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THANK YOU FOR JOINING US THIS

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MORNING AGAIN.

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WE HAD AN AMAZING DAY YESTERDAY

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WITH OUR PRAGMATIC TRIALS

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COLLABORATORY ANNUAL WORKSHOP.

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OUR TOPIC YESTERDAY AND TODAY,

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GETTING THE RIGHT EVIDENCE TO

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DECISION MAKERS FASTER, INSIGHTS

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FROM THE PRAGMATIC TRIALS

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COLLABORATORY.

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IT'S MY PLEASURE TO WELCOME YOU

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AGAIN TODAY THIS MORNING.

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MY NAME IS WENDY WEBER, AT THE

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NATIONAL CENTER FOR

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COMPLEMENTARY AND INTEGRATIVE

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HEALTH HERE AT THE NATIONAL

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INSTITUTES OF HEALTH.

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I'VE BEEN WORKING WITH THE

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PRAGMATIC TRIALS COLLABORATORY

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SINCE WE LAUNCHED IN 2011-2012,

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AND WE LEARNED A LOT OVER THE

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LAST 11+ YEARS IN THE PROGRAM.

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SO, WE'RE LOOKING FORWARD TO

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ANOTHER REALLY EXCITING DAY

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TODAY.

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YESTERDAY WE HEARD FROM SEVERAL

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TRIALS AS EXAMPLES WHAT THEY

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HAVE LEARNED AND FROM THEIR

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HEALTH CARE SYSTEM PARTNERS

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REALLY LOOKING AT WHAT HAPPENS

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WITH THE RESULTS OF THEIR

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STUDIES AND WHAT WAS

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IMPLEMENTED, SUSTAINED, CHANGED,

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MODIFIED.

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TODAY WE'LL TALK MORE ABOUT IS

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THERE ANY WAY WE CAN GET THIS

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MORNING AND LEARN RESULTS OF

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TRIALS MORE QUICKLY, DO WE GET

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SIGNALS EARLIER, WE'LL HAVE AN

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INTERESTING CONVERSATION ABOUT

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HOW TO TEASE OUT WHAT'S A SIGNAL

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AND HOW MUCH NOISE IS THERE

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AROUND THAT SIGNAL AND DO WE

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REALLY KNOW WHAT'S HAPPENING OR

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DO WE NEED TO KEEP GOING.

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SO I THINK IT'S GOING TO BE A

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REALLY EXCITING DISCUSSION

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TODAY.

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I WANT TO THANK OUR PLANNING

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COMMITTEE MEMBERS.

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TODAY YOU GOAT HEAR FROM SEVERAL

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OF OUR OTHER PLANNING COMMITTEE

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MEMBERS, FIRST SESSION MODERATED

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BY DR. KEVIN WEINFURT, SECOND BY

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DR. RICHARD PLATTE.

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WE HAVE JUST A REALLY EXCITING

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GROUP OF SPEAKERS, SOME ARE

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PRINCIPAL INVESTIGATORS FROM

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SOME TRIALS, AS WELL AS SOME OF

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OUR STAFF, NATIONAL INSTITUTES

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OF HEALTH, AS WELL AS OTHER

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PARTS OF THE FEDERAL GOVERNMENT,

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YOU'LL HEAR FROM PEOPLE IN

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SEVERAL PERSPECTIVES AS WE THINK

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ABOUT HOW DO WE LEARN FASTER AND

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THEN OUR LAST SESSION TODAY IS

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GOING TO BE WHAT COULD WE AS

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POTENTIALLY FUNDERS AS THOSE

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PROPOSING APPLICATIONS FOR

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PRAGMATIC TRIALS HOW MIGHT WE

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STRUCTURE OR PUT INCENTIVES TO

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PLACE TO LEARN MORE QUICKLY AS

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WE'RE CONDUCTING THESE TRIALS.

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I KNOW IT'S EARLY ON THE WEST

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COAST.

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BUT THANK YOU FOR JOINING US.

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FOR EVERYONE THAT IS THERE ON

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THE WEST COAST JOINING US THIS

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MORNING, AGAIN, THANK YOU TO OUR

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KEYNOTE SPEAKER.

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YESTERDAY A GREAT PERSPECTIVE

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THINKING ABOUT HOW TO THINK

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ABOUT LEARNING HEALTH CARE

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SYSTEMS AND WHAT WE NEED TO DO

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IN ORDER TO MAKE THAT HAPPEN.

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SO, I THINK I'M GOING TO GO

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AHEAD AND TURN THINGS OVER TO

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OUR FIRST PANELIST.

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OH, THANK YOU FOR THE REMINDER.

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ONE HOUSEKEEPING TIP, WE WILL

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PUT THIS E-MAIL UP AGAIN AS WE

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GET TO THE Q&A SESSIONS
BRIEFLY.

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IF YOU HAVE QUESTIONS, PLEASE DO

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SEND THEM TO THIS E-MAIL FOR THE

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WORKSHOP.

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I'M ACTUALLY MONITORING IT AND

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SO I'LL BE SURE THE QUESTIONS

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GET TO OUR PANELISTS AND TO OUR

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SPEAKERS.

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YOU CAN ALSO USE THE "LIVE

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FEEDBACK" FEATURE IN THE

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VIDEOCAST.

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IT WILL END THE E-MAIL TO THE

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SAME E-MAIL BOX TO SHARE

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QUESTIONS WITH PANELISTS AND

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SPEAKERS.

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WE DO REALLY WANT TO MAKE THIS

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ENGAGING AND SO IF YOU HAVE

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QUESTIONS PLEASE DO SEND THEM IN

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TO US.

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SO, KEVIN, I'M GOING TO TURN

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THINGS OVER TO YOU TO GET US

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STARTED IN OUR FIRST PANEL

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TODAY, LEARNING FASTER.

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>> THANK YOU SO MUCH.

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GOOD MORNING, EVERYONE.

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I'VE KEVIN WEINFURT FROM DUKE

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UNIVERSITY.

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I'M ONE OF THE CO-P.I.s OF THE

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COORDINATING CENTER OF THE

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COLLABORATORY.

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GOOD TO HAVE EVERYONE BACK WITH

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US THIS MORNING.

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AS WENDY POINTED OUT, YESTERDAY

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A FEW DIFFERENT TIMES, THIS

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THEME OF TRYING TO LEARN FASTER

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CAME UP.

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AND WE'RE GOING TO REALLY FOCUS

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ON THAT IN THIS THIRD PANEL.

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AND WE'LL HEAR SOME

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REVERBERATIONS OF SOME PRIOR

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TOPICS THAT WERE DISCUSSED, BUT

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WE'LL BE LOOKING AT THEM IN THE

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CONTEXT OF HOW WE MIGHT LEARN

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FASTER.

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AND, YOU KNOW, WE'VE OBSERVED AT

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LEAST THREE DIFFERENT SITUATIONS

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WITH PRIOR TRIALS, WHERE IT

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MIGHT BE APPROPRIATE TO MODIFY

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OR END A STUDY.

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ONE SITUATION IS DETERMINATION

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IN THE PLANNING FACE  -- PHASE

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THE INTERVENTION IS NOT FEASIBLE

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OR ETHICAL.

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WE'VE SEEN SITUATIONS WITH

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INABILITY TO EFFECTIVELY

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IMPLEMENT THE INTERVENTION.

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AND THERE'S ALSO THE POSSIBILITY

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THAT WE COULD DETERMINE THE

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INTERVENTION HAS ALREADY MET ITS

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MAJOR AIM BEFORE THE END OF THE

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STUDY, OR IT'S UNLIKELY TO DO SO

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WHICH YOU MIGHT REGARD AS

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FUTILITY.

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SOME OF THESE ISSUES ARE GOING

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TO SOUND FAMILIAR FOR

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TRADITIONAL TRIALS, WHERE WE

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MIGHT HAVE A DSMB ADVISING A

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TRIAL BE STOPPED BECAUSE OF

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OVERWHELMING EVIDENCE OF BENEFIT

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OR FUTILITY.

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BUT WE'LL BE TALKING ABOUT SOME

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OF THE ISSUES THAT COME TO PLAY

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IN PRAGMATIC TRIALS.

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THERE'S SOME INTERESTING WRING

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WRINKLES, ONE INGREDIENT OF THE

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INTERVENTION BEAK TESTED MIGHT

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BE EXPLICIT FOR MONITORING

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INTERVENTIONS, WE HAVE TWO MAJOR

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QUESTIONS THAT WE'RE LOOKING AT

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IN THIS SECTION.

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THE FIRST IS HOW SOON

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INVESTIGATORS MIGHT KNOW THAT A

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TRIAL IS UNLIKELY TO SUCCEED IF

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IT STAYS ON ITS PRESENT COURSE,

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WHAT ARE OPPORTUNITIES AND

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CHALLENGES FOR MONITORING

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SIGNALS IN REAL TIME ABOUT THE

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INTERVENTION AND THE

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IMPLEMENTATION OF THE

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INTERVENTION.

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SO, WE'LL HAVE ONE GROUP OF

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DISCUSSANTS ADDRESSING THIS

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QUESTION OF WHAT ARE THE

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OPPORTUNITIES AND CHALLENGES FOR

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GETTING EARLIER SIGNALS.

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THEN THE SECOND POINT OF

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DISCUSSION IS WHAT ARE THE

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CONSIDERATIONS FOR DECIDING WHEN

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AND HOW TO ACT ON THESE SIGNALS

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THAT WE MIGHT BE GETTING, AND

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WE'RE GOING HEAR FROM DIFFERENT

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PERSPECTIVES, THOSE INVOLVED

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WITH DSMBs, SPONSOR

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PERSPECTIVE, BOTH ETHICS,

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BIOSTATISTICS.

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WE SHOULD HAVE A GREAT

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DISCUSSION TO SURFACE SOME OF

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THESE CONSIDERATIONS WHEN TRYING

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TO ACT ON EARLY SIGNALS THAT

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MIGHT BE COMING IN.

202
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SO, LET'S START IN WITH OUR

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FIRST SECTION HERE.

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AND WE HAVE THREE OF OUR

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COLLABORATORY PRINCIPAL

206
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INVESTIGATORS, WHO ARE GOING TO

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BE SPEAKING AND SHARING A LITTLE

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BIT OF THEIR EXPERIENCE.

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AND SO I'D LIKE TO START OUT

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WITH DR. GLORIA CORONADO,

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TALKING ABOUT THE STOP CRC AND

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RELATED EXPERIENCES.

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GOOD MORNING, GLORIA.

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>> GOOD MORNING.

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GOOD MORNING.

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>> THANK YOU FOR GETTING
UP

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EARLY FOR US.

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>> YOU'RE VERY WELCOME.

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YEAH, THANK YOU FOR KICKING OFF

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THIS VERY INTERESTING PANEL.

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SO I'M GOING TO START JUST BY

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GIVING YOU A TWO SENTENCE

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BACKGROUND ABOUT STOP CRC AND

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THEN SOME OF THE WAYS I FEEL

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LIKE WE GOT SOME EARLY SIGNALS

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OR INFORMATION ABOUT THE STUDY

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THAT I THINK WERE REALLY

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CRITICAL AND HELPED US MAKE

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DECISIONS ABOUT GETTING

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INFORMATION TO DECISION MAKERS

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IN ORDER TO REDUCE SOME BARRIERS

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THAT WE WERE ENCOUNTERING.

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STOP CRC WAS A PRAGMATIC STUDY,

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ONE OF THE FIRST -- FUNDED IN

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THE FIRST ROUND OF THE NIH

236
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COLLABORATORY AND FOCUSED ON

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TESTING INTERVENTION TO REDUCE

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RATES OF COLORECTAL SCREENING IN

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FEDERALLY QUALIFIED HEALTH

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CENTERS, RECRUITED 26 QUALIFIED

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CLINICS IN OREGON OR NORTHERN

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CALIFORNIA, AND WE DID A CLUSTER

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RANDOMIZED DESIGN TO TEST MALE

244
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FIT INTERVENTION DELIVERED

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PRAGMATICALLY BY CLINIC STAFF.

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00:09:08,240 --> 00:09:10,360
WE DEVELOPED ELECTRONIC HEALTH

247
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RECORD TOOLS TO IDENTIFY

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PATIENTS DUE FOR SCREENING AND

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DELIVERING EACH STEP OF THIS

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MULTI-STEP INTERVENTION TO MAIL

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FIT KITS TO PATIENTS DUE FOR

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CAREENING. 

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SOUNDS LIKE A STRAIGHT FORWARD

254
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INTERVENTION.

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WE ASSEMBLED -- ONE OF THE

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CRITICAL THINGS AT THE BEGINNING

257
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WAS ASSEMBLE AN ADVISORY BOARD

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THAT CONSISTED OF MOST OF THE

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MEDICAL DIRECTORS FROM OUR

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FEDERALLY QUALIFIED HEALTH

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CENTERS, AS WELL AS OTHER

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STAKEHOLDERS AND REPRESENTATIVES

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FROM COMMUNITY ORGANIZATIONS.

264
00:09:50,440 --> 00:09:53,040
I REMEMBER KIND OF OUR FIRST

265
00:09:53,040 --> 00:09:54,120
IN-PERSON MEETING.

266
00:09:54,120 --> 00:09:56,520
I THINK WE'VE SCHEDULED LIKE

267
00:09:56,520 --> 00:09:59,920
FIVE HOURS DURING A DAY.

268
00:09:59,920 --> 00:10:03,200
WE BROUGHT EVERYBODY IN TO OUR

269
00:10:03,200 --> 00:10:03,880
HEADQUARTERED LOCATION IN

270
00:10:03,880 --> 00:10:04,560
PORTLAND, OREGON.

271
00:10:04,560 --> 00:10:06,600
WE SHARED ABOUT THE STUDY AND WE

272
00:10:06,600 --> 00:10:10,800
KIND OF FACILITATED A VARIETY OF

273
00:10:10,800 --> 00:10:13,440
CONVERSATIONS, AT THAT TIME THIS

274
00:10:13,440 --> 00:10:15,840
WAS LIKE 2012 OR 2013.

275
00:10:15,840 --> 00:10:17,040
AND AT THAT TIME, THE AFFORDABLE

276
00:10:17,040 --> 00:10:19,240
CARE ACT HAD JUST RECENTLY

277
00:10:19,240 --> 00:10:19,760
PASSED.

278
00:10:19,760 --> 00:10:20,640
AS PART OF THE AFFORDABLE CARE

279
00:10:20,640 --> 00:10:23,160
ACT THERE WAS A PREVENTIVE

280
00:10:23,160 --> 00:10:27,440
HEALTH MANDATE THAT NOW PAID FOR

281
00:10:27,440 --> 00:10:28,960
SCREENINGS, ALL KINDS OF CANCER

282
00:10:28,960 --> 00:10:30,520
SCREENINGS THAT WERE RECOMMENDED

283
00:10:30,520 --> 00:10:33,240
BY U.S. PREVENTIVE SERVICES TASK

284
00:10:33,240 --> 00:10:35,000
FORCE WITH NO COST, NO CO-PAYS

285
00:10:35,000 --> 00:10:35,760
TO PATIENTS.

286
00:10:35,760 --> 00:10:39,600
SO ONE OF THE THINGS THIS BOARD,

287
00:10:39,600 --> 00:10:41,880
THE MEDICAL DIRECTORS OR

288
00:10:41,880 --> 00:10:44,360
CONCERNS THE MEDICAL DIRECTORS

289
00:10:44,360 --> 00:10:48,440
RAISED IS THAT BY REFERRING

290
00:10:48,440 --> 00:10:51,520
PATIENTS TO FIT TESTING OR

291
00:10:51,520 --> 00:10:54,040
OFFERING PATIENTS FIT TESTING IF

292
00:10:54,040 --> 00:10:56,120
THAT PATIENT HAD ABNORMAL FIT

293
00:10:56,120 --> 00:10:57,760
TEST RESULT THEY WOULD FACE

294
00:10:57,760 --> 00:11:01,280
CO-PAYS FOR THE FOLLOW-UP COLON

295
00:11:01,280 --> 00:11:01,520
ONOSCOPY.

296
00:11:01,520 --> 00:11:03,800
IF THE PATIENT WERE REFERRED

297
00:11:03,800 --> 00:11:04,920
DIRECTLY FOR COLONOSCOPY THERE

298
00:11:04,920 --> 00:11:06,760
WOULD BE NO CO-PAYS ACCORDING TO

299
00:11:06,760 --> 00:11:07,400
PREVENTIVE HEALTH MANDATE.

300
00:11:07,400 --> 00:11:10,160
ONE OF THE THINGS THIS BOARD DID

301
00:11:10,160 --> 00:11:12,120
WAS, YOU KNOW, WORK WITH OUR

302
00:11:12,120 --> 00:11:16,240
LEGISLATIVE LEAD THAT WAS ON OUR

303
00:11:16,240 --> 00:11:17,800
BOARD, SO MITCH GREENLAKE WAS

304
00:11:17,800 --> 00:11:18,880
FOUND EVERY MY RESEARCH CENTER.

305
00:11:18,880 --> 00:11:20,280
I HAVE A POSITION THAT'S NAMED

306
00:11:20,280 --> 00:11:21,520
AFTER HIM.

307
00:11:21,520 --> 00:11:23,280
HE WAS ON OUR BOARD.

308
00:11:23,280 --> 00:11:25,520
AND SO IT WAS PRETTY EASY TO

309
00:11:25,520 --> 00:11:29,640
WORK WITH HIM TO SAY, GOSH, THIS

310
00:11:29,640 --> 00:11:30,840
IS AN IMPORTANT CHALLENGE THAT

311
00:11:30,840 --> 00:11:34,880
ALL OF OUR CLINICS ARE FACING IN

312
00:11:34,880 --> 00:11:35,880
TERMS OF IT'S REALLY IMPACTING

313
00:11:35,880 --> 00:11:38,400
HOW THIS PROGRAM WILL BE

314
00:11:38,400 --> 00:11:39,480
IMPLEMENTED AND HOW THE

315
00:11:39,480 --> 00:11:43,040
PATIENT -- WHETHER OR NOT THE

316
00:11:43,040 --> 00:11:44,240
PATIENTS WILL EXPERIENCE OR

317
00:11:44,240 --> 00:11:47,000
PHASE, YOU KNOW, SUBSTANTIAL

318
00:11:47,000 --> 00:11:48,000
CO-PAYS TO GETTING THE

319
00:11:48,000 --> 00:11:48,600
RECOMMENDED SERVICE.

320
00:11:48,600 --> 00:11:52,640
AND SO WE WERE ABLE TO WORK WITH

321
00:11:52,640 --> 00:11:54,760
MITCH TO EDUCATE LEGISLATORS WHO

322
00:11:54,760 --> 00:11:56,480
EVENTUALLY CHANGED THE POLICY IN

323
00:11:56,480 --> 00:11:58,560
OUR STATE, AND FOR THOSE THAT

324
00:11:58,560 --> 00:12:00,720
TRACK THIS POLICY YOU'LL KNOW

325
00:12:00,720 --> 00:12:03,280
THAT IT'S NOW A LOT OF THE LAND.

326
00:12:03,280 --> 00:12:04,520
SO NATIONAL POLICY HAS BEEN

327
00:12:04,520 --> 00:12:06,360
CHANGED IN ACCORDANCE WITH THE

328
00:12:06,360 --> 00:12:07,880
POLICY THAT WAS CHANGED HERE IN

329
00:12:07,880 --> 00:12:09,200
OREGON YEARS AND YEARS AGO.

330
00:12:09,200 --> 00:12:11,280
SO, I THINK THAT'S AN EXAMPLE OF

331
00:12:11,280 --> 00:12:14,240
SOMETHING THAT WE LEARNED THAT

332
00:12:14,240 --> 00:12:15,680
WAS ESSENTIALLY A POLICY LEVEL

333
00:12:15,680 --> 00:12:18,520
BARRIER THAT WE WERE ABLE TO

334
00:12:18,520 --> 00:12:20,920
CHANGE BECAUSE WE HAD CONVENED

335
00:12:20,920 --> 00:12:22,560
THIS GROUP OF STAKEHOLDERS WHO

336
00:12:22,560 --> 00:12:24,000
WERE FACING THIS ISSUE IN THEIR

337
00:12:24,000 --> 00:12:30,320
CLINIC DAY IN AND DAY OUT.

338
00:12:30,320 --> 00:12:31,640
AND SO THAT HAPPENED TO BE AN

339
00:12:31,640 --> 00:12:34,360
EARLY LEARNING WE WERE ABLE TO

340
00:12:34,360 --> 00:12:36,680
TAKE ACTION ON TO IMPROVE

341
00:12:36,680 --> 00:12:37,600
REDUCED BARRIERS TO IMPLEMENTING

342
00:12:37,600 --> 00:12:42,160
OUR PROGRAM OVER THE COURSE OF

343
00:12:42,160 --> 00:12:42,600
THE STUDY.

344
00:12:42,600 --> 00:12:45,320
THE OTHER EXAMPLE THAT I WANT TO

345
00:12:45,320 --> 00:12:55,880
GIVE, AND I THINK I CREDIT RUSS

346
00:12:57,680 --> 00:13:04,240
GOSGO, A PROGRAM CENTER, AN

347
00:13:04,240 --> 00:13:04,840
APPROACH.

348
00:13:04,840 --> 00:13:09,560
THIS IS A VERY COMMON AND WELL

349
00:13:09,560 --> 00:13:12,720
KNOWN STRATEGY TO -- OF

350
00:13:12,720 --> 00:13:15,560
ITERATIVE SMALL TEST OF CHANGE,

351
00:13:15,560 --> 00:13:17,320
CLINICS ARE TYPICALLY TRAINED

352
00:13:17,320 --> 00:13:19,280
AND FAMILIAR WITH, THAT ALLOWS

353
00:13:19,280 --> 00:13:20,800
THEM TO REALLY IMPROVE A

354
00:13:20,800 --> 00:13:21,560
PROCESS.

355
00:13:21,560 --> 00:13:26,840
AND SO WE DECIDED TO TAKE RUSS'

356
00:13:26,840 --> 00:13:28,160
ADVICE, AND USE PLANNED USE

357
00:13:28,160 --> 00:13:30,360
STUDIES AS OUR STRATEGY FOR

358
00:13:30,360 --> 00:13:31,640
SUPPORTING AND FACILITATING THE

359
00:13:31,640 --> 00:13:33,000
IMPLEMENTATION OF THE PROGRAM

360
00:13:33,000 --> 00:13:33,720
WITHIN OUR CLINICS.

361
00:13:33,720 --> 00:13:37,640
AND SO WE WORKED WITH OUR

362
00:13:37,640 --> 00:13:39,440
PRIMARY CARE ASSOCIATION TO KIND

363
00:13:39,440 --> 00:13:41,880
OF DO A BOOSTER TRAINING AT EACH

364
00:13:41,880 --> 00:13:45,880
ONE OF OUR KIND OF LEADERSHIP

365
00:13:45,880 --> 00:13:48,880
TEAMS OF EACH HEALTH CENTER AND

366
00:13:48,880 --> 00:13:50,640
CREATED A FORUM THAT WOULD HAVE

367
00:13:50,640 --> 00:13:52,520
THEM GIVE US THEIR IDEA FOR A

368
00:13:52,520 --> 00:13:53,480
SINGLE CYCLE AND WE WERE GOING

369
00:13:53,480 --> 00:13:55,240
TO ASK THEM TO REPORT BACK ON

370
00:13:55,240 --> 00:13:56,960
THE FINDINGS FROM THAT CYCLE.

371
00:13:56,960 --> 00:13:59,360
AND SO GOING INTO THIS PROCESS,

372
00:13:59,360 --> 00:14:01,680
WE ANTICIPATED THAT OUR CLINICS

373
00:14:01,680 --> 00:14:04,200
WOULD TEST OUT DIFFERENT

374
00:14:04,200 --> 00:14:05,280
REMINDER APPROACHES, LIKE MAKE

375
00:14:05,280 --> 00:14:06,400
ADDITIONAL PHONE CALL TO

376
00:14:06,400 --> 00:14:09,240
PATIENTS OR REALLY KIND OF FOCUS

377
00:14:09,240 --> 00:14:11,080
IN HOW TO INCREASE RETURN RATES

378
00:14:11,080 --> 00:14:14,920
ON THE FIT KITS BEING MAILED OUT

379
00:14:14,920 --> 00:14:16,040
TO PATIENTS FOR COLORECTAL

380
00:14:16,040 --> 00:14:17,560
CANCER SCREENING.

381
00:14:17,560 --> 00:14:20,720
TO OUR SURPRISE, WE FOUND ALL

382
00:14:20,720 --> 00:14:22,360
KINDS OF ADDITIONAL

383
00:14:22,360 --> 00:14:23,720
IMPLEMENTATION BARRIERS THAT WE

384
00:14:23,720 --> 00:14:25,720
PROBABLY WOULDN'T HAVE FOUND OUT

385
00:14:25,720 --> 00:14:26,200
ABOUT OTHERWISE.

386
00:14:26,200 --> 00:14:28,680
AND SO ONE OF OUR CLINICS SAID,

387
00:14:28,680 --> 00:14:32,120
WELL, WE WANT TO FOCUS OUR PDSA

388
00:14:32,120 --> 00:14:34,760
ON THE ISSUES WE'RE HAVING WITH

389
00:14:34,760 --> 00:14:36,920
OUR LAB BECAUSE WE'RE GETTING

390
00:14:36,920 --> 00:14:40,520
COMPLETED FIT TESTS RETURNED BUT

391
00:14:40,520 --> 00:14:42,160
THROWING THEM OUT BECAUSE THEY

392
00:14:42,160 --> 00:14:45,120
DON'T HAVE A COLLECTION DATE.

393
00:14:45,120 --> 00:14:46,440
OUR REFERENCE LAB WILL NOT

394
00:14:46,440 --> 00:14:47,400
PROCESS WITHOUT A COLLECTION

395
00:14:47,400 --> 00:14:47,960
DATE.

396
00:14:47,960 --> 00:14:51,240
THIS LED TO THINKING THROUGH THE

397
00:14:51,240 --> 00:14:52,000
PROCESS, AND CHANGING THE

398
00:14:52,000 --> 00:14:54,120
MATERIALS THEY WERE SENDING TO

399
00:14:54,120 --> 00:14:55,640
PATIENTS TO EMPHASIZE THE

400
00:14:55,640 --> 00:14:56,520
IMPORTANCE OF ADDING THAT

401
00:14:56,520 --> 00:14:57,480
COLLECTION DATE.

402
00:14:57,480 --> 00:14:59,680
SO THIS IS A VERY PRACTICAL

403
00:14:59,680 --> 00:15:01,960
EXAMPLE OF SOMETHING THAT MIGHT

404
00:15:01,960 --> 00:15:03,160
BE INTERFERING WITH THE RESULTS

405
00:15:03,160 --> 00:15:04,600
OF YOUR STUDY.

406
00:15:04,600 --> 00:15:06,440
SO IN OUR CASE, THOSE KITS THAT

407
00:15:06,440 --> 00:15:10,200
WERE BEING THROWN OUT WERE NOT

408
00:15:10,200 --> 00:15:11,800
BEING CREDITED AS A SUCCESS OF

409
00:15:11,800 --> 00:15:13,480
THE STUDY AND SO IT WAS REALLY

410
00:15:13,480 --> 00:15:16,520
CLEAR PROBLEM THAT ALL OF US

411
00:15:16,520 --> 00:15:17,440
WANTED TO FIX.

412
00:15:17,440 --> 00:15:21,040
AND, AGAIN, IT'S SOMETHING THAT

413
00:15:21,040 --> 00:15:22,240
WE PROBABLY WOULD NEVER HAD

414
00:15:22,240 --> 00:15:24,640
LEARNED ABOUT HAD WE NOT USED

415
00:15:24,640 --> 00:15:27,360
THE PDSA CYCLES.

416
00:15:27,360 --> 00:15:34,920
SO MY EXAMPLES ARE TANGIBLE TO

417
00:15:34,920 --> 00:15:36,760
HOW YOU MIGHT LEARN FASTER,

418
00:15:36,760 --> 00:15:38,200
ABOUT CON CAREENING MEDICAL

419
00:15:38,200 --> 00:15:39,760
DIRECTORS AND PEOPLE --

420
00:15:39,760 --> 00:15:44,320
CONVENING MEDICAL VECTORS AND

421
00:15:44,320 --> 00:15:47,720
POLICY LEVERS THAT MIGHT NEED TO

422
00:15:47,720 --> 00:15:49,680
BE CHANGED, ALSO QUALIFY

423
00:15:49,680 --> 00:15:50,560
IMPROVEMENT PROCESS PDSAs THAT

424
00:15:50,560 --> 00:15:52,760
WAS HELPFUL.

425
00:15:52,760 --> 00:15:53,280
SO I'LL STOP THERE.

426
00:15:53,280 --> 00:15:56,400
>> THANK YOU SO MUCH,
GLORIA.

427
00:15:56,400 --> 00:15:59,040
THAT WAS TERRIFIC.

428
00:15:59,040 --> 00:16:06,760
OUR NEXT COLLABORATORY P.I., DR.

429
00:16:06,760 --> 00:16:07,760
NATALIA MORONE, EXPERIENCES IN

430
00:16:07,760 --> 00:16:09,600
THE OPTIMUM TRIAL AND OTHER

431
00:16:09,600 --> 00:16:10,960
RELATED EXPERIENCES.

432
00:16:10,960 --> 00:16:11,320
GOOD MORNING.

433
00:16:11,320 --> 00:16:13,800
>> GOOD MORNING, KEVIN
AND

434
00:16:13,800 --> 00:16:14,040
EVERYONE.

435
00:16:14,040 --> 00:16:15,640
I'M GLAD -- THANK YOU FOR

436
00:16:15,640 --> 00:16:17,960
INVITING ME TO SPEAK TODAY.

437
00:16:17,960 --> 00:16:21,560
A LITTLE BIT OF QUICK

438
00:16:21,560 --> 00:16:26,840
BACKGROUND, THE OPTIMUM TRIAL IS

439
00:16:26,840 --> 00:16:27,720
A TELEHEALTH-DELIVERED GROUP

440
00:16:27,720 --> 00:16:28,880
MINDFULNESS PROGRAM FOR PERSONS

441
00:16:28,880 --> 00:16:32,080
WHO HAVE CHRONIC LOW BACK PAIN.

442
00:16:32,080 --> 00:16:34,160
AND IT'S BEING OFFERED CURRENTLY

443
00:16:34,160 --> 00:16:36,120
SO WE'RE STILL DOING THE

444
00:16:36,120 --> 00:16:36,560
CLINICAL TRIAL.

445
00:16:36,560 --> 00:16:41,800
WE'RE TOWARDS OF END OF

446
00:16:41,800 --> 00:16:42,160
RECRUITMENT.

447
00:16:42,160 --> 00:16:51,200
WE'RE IN OUR YEAR FOUR OF OUR

448
00:16:51,200 --> 00:16:52,760
UH3 PRAGMATIC -- AWARD, A

449
00:16:52,760 --> 00:16:54,480
PRAGMATIC TRIAL.

450
00:16:54,480 --> 00:16:57,040
I REALLY ENJOYED LISTENING TO

451
00:16:57,040 --> 00:16:59,960
WHAT GLORIA HAD TO SAY, AND I

452
00:16:59,960 --> 00:17:04,120
THINK WE MAY BE STARTING A

453
00:17:04,120 --> 00:17:04,320
SCENE.

454
00:17:04,320 --> 00:17:06,640
WHEN WE STARTED THE TRIAL, WE

455
00:17:06,640 --> 00:17:10,440
HAD ALREADY AHEAD OF TIME

456
00:17:10,440 --> 00:17:13,320
PLANNED TO DO -- HAVE A

457
00:17:13,320 --> 00:17:15,720
COMMUNITY ADVISORY BOARD AND

458
00:17:15,720 --> 00:17:18,760
PLANNED TO INTERVIEW DIFFERENT

459
00:17:18,760 --> 00:17:20,320
STAKEHOLDERS AND PARTICULARLY

460
00:17:20,320 --> 00:17:24,240
WHAT ENDED UP BEING PRESCIENT IN

461
00:17:24,240 --> 00:17:26,440
RETROSPECT IS WE DID A LITTLE

462
00:17:26,440 --> 00:17:28,520
PILOT STUDY OF THE INTERVENTION.

463
00:17:28,520 --> 00:17:30,600
THIS IS ALL PLANNED AHEAD OF

464
00:17:30,600 --> 00:17:32,360
TIME, BEFORE WE ACTUALLY

465
00:17:32,360 --> 00:17:33,760
DELIVERED THE LARGER

466
00:17:33,760 --> 00:17:35,080
INTERVENTION.

467
00:17:35,080 --> 00:17:38,040
AND THAT'S HOW THE UG3/UH3s

468
00:17:38,040 --> 00:17:40,000
ARE SET UP.

469
00:17:40,000 --> 00:17:45,480
IT TURNS OUT WE HAD TO QUICKLY

470
00:17:45,480 --> 00:17:47,960
PIVOT IN 2020 TO A

471
00:17:47,960 --> 00:17:48,400
TELEHEALTH-DELIVERED

472
00:17:48,400 --> 00:17:49,120
INTERVENTION INSTEAD OF IN

473
00:17:49,120 --> 00:17:52,400
PERSON BECAUSE OF THE PANDEMIC.

474
00:17:52,400 --> 00:17:58,720
AND SO AT THE TIME, WE WERE NOT

475
00:17:58,720 --> 00:18:02,320
PLANNING THAT, WHICH MEANT WE

476
00:18:02,320 --> 00:18:04,800
HAD TO PIVOT IN THE WAY THAT THE

477
00:18:04,800 --> 00:18:05,560
INTERVENTION WOULD BE DELIVERED

478
00:18:05,560 --> 00:18:07,960
BECAUSE IT WAS NOT GOING TO BE

479
00:18:07,960 --> 00:18:11,920
DELIVERED BY A GROUP AND ONLINE.

480
00:18:11,920 --> 00:18:15,960
AND ALSO MAKING SURE THAT OUR

481
00:18:15,960 --> 00:18:20,760
PARTICIPANTS WHICH WE HAVE

482
00:18:20,760 --> 00:18:22,680
DIVERSE PARTICIPANTS, WE'RE AT A

483
00:18:22,680 --> 00:18:27,480
SAFETY NET HOSPITAL HERE IN

484
00:18:27,480 --> 00:18:30,800
BOSTON, WE HAD TO MAKE SURE OUR

485
00:18:30,800 --> 00:18:33,080
PARTICIPANTS COULD ACCESS THE

486
00:18:33,080 --> 00:18:34,400
PROGRAM THROUGH THEIR

487
00:18:34,400 --> 00:18:34,680
TECHNOLOGY.

488
00:18:34,680 --> 00:18:37,760
AND SO WHEN WE RAN THE PILOT, WE

489
00:18:37,760 --> 00:18:38,720
DID IT ONLINE.

490
00:18:38,720 --> 00:18:43,120
AND WE WERE ABLE TO ASK THE

491
00:18:43,120 --> 00:18:44,440
PARTICIPANTS BECAUSE IT WAS

492
00:18:44,440 --> 00:18:45,840
OFFLINE AHEAD OF TIME, WE WERE

493
00:18:45,840 --> 00:18:47,080
PLANNING TO DO EXIT INTERVIEWS

494
00:18:47,080 --> 00:18:50,800
BUT WE WERE ABLE TO PIVOT VERY

495
00:18:50,800 --> 00:18:52,760
QUICKLY TO GET FEEDBACK ON THOSE

496
00:18:52,760 --> 00:18:56,160
EXIT INTERVIEWS ABOUT THE

497
00:18:56,160 --> 00:18:59,680
DELIVERY OF THE INTERVENTION,

498
00:18:59,680 --> 00:19:01,520
AND HOW AS A PARTICIPANTS AND AS

499
00:19:01,520 --> 00:19:03,400
A PATIENT HOW IT WAS FOR THEM.

500
00:19:03,400 --> 00:19:07,080
SO WE WERE -- I WAS VERY FOCUSED

501
00:19:07,080 --> 00:19:12,360
INITIALLY AS P.I. OF OPTIMUM

502
00:19:12,360 --> 00:19:14,000
MAKING SURE WE WERE FAITHFUL TO

503
00:19:14,000 --> 00:19:15,080
THE INTERVENTION WHICH NOW HAD

504
00:19:15,080 --> 00:19:16,200
TO BE DELIVERED ONLINE.

505
00:19:16,200 --> 00:19:17,920
THAT WAS VERY, VERY HELPFUL.

506
00:19:17,920 --> 00:19:23,080
AND WHAT WAS SO HELPFUL ABOUT

507
00:19:23,080 --> 00:19:24,760
DOING THAT VERY EARLY PILOT WAS

508
00:19:24,760 --> 00:19:26,800
THE TYPE OF COMMENTS THAT PEOPLE

509
00:19:26,800 --> 00:19:28,120
WERE SAYING ABOUT THE

510
00:19:28,120 --> 00:19:32,040
INTERVENTION AND WAS IN LINE

511
00:19:32,040 --> 00:19:35,560
WITH WHAT QUALITATIVE DATA WITH

512
00:19:35,560 --> 00:19:38,720
MINDFULNESS INTERVENTION. 

513
00:19:38,720 --> 00:19:40,480
SO THEY WERE APPLYING THE

514
00:19:40,480 --> 00:19:42,040
METHODS NOT ONLY TO THEIR PAIN

515
00:19:42,040 --> 00:19:44,960
BUT ALSO TO THEIR DAILY LIVES.

516
00:19:44,960 --> 00:19:47,400
SO THERE WAS REASSURANCE EARLY

517
00:19:47,400 --> 00:19:50,040
THAT DELIVERING IN THIS MODE WAS

518
00:19:50,040 --> 00:19:52,200
GOING TO BE OKAY.

519
00:19:52,200 --> 00:20:02,720
AND SO THAT WAS VERY HELPFUL.

520
00:20:03,640 --> 00:20:06,520
THE OTHER, AGAIN, PLAN AHEAD OF

521
00:20:06,520 --> 00:20:08,960
TIME WHICH ENDED UP BEING

522
00:20:08,960 --> 00:20:14,320
HELPFUL ANTICIPATING IT WAS VERY

523
00:20:14,320 --> 00:20:15,720
EARLY COLLABORATION AMONG THE

524
00:20:15,720 --> 00:20:17,720
MINDFULNESS INSTRUCTORS AS WELL

525
00:20:17,720 --> 00:20:19,640
AS PRIMARY CARE PROVIDERS.

526
00:20:19,640 --> 00:20:21,760
THIS IS AN INTERVENTION

527
00:20:21,760 --> 00:20:22,960
DELIVERED IN PRIMARY CARE.

528
00:20:22,960 --> 00:20:24,160
AND I HAVE ALWAYS BEEN

529
00:20:24,160 --> 00:20:27,320
INTERESTED IN HAVING THE PRIMARY

530
00:20:27,320 --> 00:20:28,120
CARE PROVIDER INVOLVED.

531
00:20:28,120 --> 00:20:30,400
AND SO FROM THE BEGINNING THERE

532
00:20:30,400 --> 00:20:31,520
WAS VERY CLOSE COMMUNICATION

533
00:20:31,520 --> 00:20:33,040
BETWEEN THE TWO.

534
00:20:33,040 --> 00:20:37,200
AND WE HAD TO PIVOT IN PERSON TO

535
00:20:37,200 --> 00:20:41,120
ONLINE, THIS BECAME EVEN MORE

536
00:20:41,120 --> 00:20:41,680
IMPORTANT.

537
00:20:41,680 --> 00:20:42,800
THOSE ALREADY PLANNED

538
00:20:42,800 --> 00:20:47,120
COMMUNICATIONS AMONG THE TEAM

539
00:20:47,120 --> 00:20:50,040
ITSELF, TO BE AS, AGAIN, FOR

540
00:20:50,040 --> 00:20:53,840
FIDELITY OF DELIVERY OF THE

541
00:20:53,840 --> 00:20:54,160
INTERVENTION.

542
00:20:54,160 --> 00:21:00,360
THAT ENDED UP BEING VERY, VERY

543
00:21:00,360 --> 00:21:00,720
HELPFUL.

544
00:21:00,720 --> 00:21:10,560
THIS IS SIMILAR TO WHAT GLORIA

545
00:21:10,560 --> 00:21:11,960
WAS SAYING, PLANNED AHEAD TO

546
00:21:11,960 --> 00:21:13,520
HAVE STAKEHOLDER INVOLVEMENT.

547
00:21:13,520 --> 00:21:16,240
IN OUR CASE WE HAD IMMEDIATELY

548
00:21:16,240 --> 00:21:16,920
INVOLVEMENT FROM OUR

549
00:21:16,920 --> 00:21:19,320
PARTICIPANTS EVEN IN THE PILOT

550
00:21:19,320 --> 00:21:21,840
THAT REALLY GAVE ME A LOT OF

551
00:21:21,840 --> 00:21:27,080
REASSURANCE THAT THE PIVOT THAT

552
00:21:27,080 --> 00:21:29,360
WE WERE MAKING WAS STILL GOING

553
00:21:29,360 --> 00:21:31,880
TO DELIVER THE INTERVENTION THE

554
00:21:31,880 --> 00:21:39,480
WAY I HAD INTENDED.

555
00:21:39,480 --> 00:21:42,320
THE OTHER -- LOOKING BACK TO

556
00:21:42,320 --> 00:21:47,360
WHAT KEVIN HAD MENTIONED, YES,

557
00:21:47,360 --> 00:21:51,960
SO ADDRESSING THE ISSUES AS THEY

558
00:21:51,960 --> 00:21:55,040
AROSE WAS, AGAIN, VERY HELPFUL.

559
00:21:55,040 --> 00:21:59,280
THESE, AS WE STARTED THE MAIN

560
00:21:59,280 --> 00:22:01,280
TRIAL, HAVING THE FEEDBACK FROM

561
00:22:01,280 --> 00:22:04,000
PARTICIPANTS AND FROM THE VERY

562
00:22:04,000 --> 00:22:10,760
BEGINNING ENDED UP BEING VERRY

563
00:22:10,760 --> 00:22:11,520
HELPFUL PUTTING SIGNIFICANT

564
00:22:11,520 --> 00:22:13,600
AMOUNT OF TIME TEACHING THEM HOW

565
00:22:13,600 --> 00:22:15,040
TO USE TECHNOLOGY.

566
00:22:15,040 --> 00:22:17,120
SIMPLE THINGS LOCALLY THAT REAL

567
00:22:17,120 --> 00:22:19,960
MADE A DIFFERENCE IN BOSTON, A

568
00:22:19,960 --> 00:22:22,200
LOT OF OUR PARTICIPANTS USE

569
00:22:22,200 --> 00:22:24,440
PHONES AND THEY WERE VERY HAPPY

570
00:22:24,440 --> 00:22:26,760
USING THE INTERVENTION ON THEIR

571
00:22:26,760 --> 00:22:27,000
PHONE.

572
00:22:27,000 --> 00:22:28,160
WHEREAS IN THE PITTSBURGH THEY

573
00:22:28,160 --> 00:22:31,240
WERE MORE LIKELY TO USE LIKE A

574
00:22:31,240 --> 00:22:34,200
LAPTOP, FOR EXAMPLE.

575
00:22:34,200 --> 00:22:35,720
THESE SIMPLE THINGS GAVE ME A

576
00:22:35,720 --> 00:22:37,480
LOT OF REASSURANCE THAT PIVOTING

577
00:22:37,480 --> 00:22:39,200
AND HOW THE INTERVENTION WAS

578
00:22:39,200 --> 00:22:40,960
BEING DELIVERED, WHICH WAS A

579
00:22:40,960 --> 00:22:44,680
MAJOR CHANGE GOING FROM

580
00:22:44,680 --> 00:22:47,560
IN-PERSON TO BASICALLY PEOPLE

581
00:22:47,560 --> 00:22:56,960
BEING IN THEIR HOMES, WATCHING A

582
00:22:56,960 --> 00:22:58,360
SCREEN, WAS STILL GIVING WHAT WE

583
00:22:58,360 --> 00:23:00,200
WERE INTENDING.

584
00:23:00,200 --> 00:23:01,760
THESE WERE WAYS WE WERE ABLE TO

585
00:23:01,760 --> 00:23:03,840
HARNESS WHAT WE ALREADY BUILT

586
00:23:03,840 --> 00:23:07,680
INTO THE TRIAL TO ACTUALLY DO A

587
00:23:07,680 --> 00:23:12,320
VERY QUICK PIVOT THAT WAS AT THE

588
00:23:12,320 --> 00:23:15,320
TIME UNEXPECTED BUT I THINK THIS

589
00:23:15,320 --> 00:23:16,280
IS WHERE HAVING THINKING-AHEAD

590
00:23:16,280 --> 00:23:17,400
TIME AS COMMUNITY ADVISORY

591
00:23:17,400 --> 00:23:22,880
BOARDS AND STAKEHOLDERS AS WELL

592
00:23:22,880 --> 00:23:24,320
AS PARTICIPANTS.

593
00:23:24,320 --> 00:23:25,400
THE OTHER, AGAIN, THAT WE BUILT

594
00:23:25,400 --> 00:23:27,480
IN AHEAD OF TIME WAS THE TEAM.

595
00:23:27,480 --> 00:23:30,880
SO TEAM MEETINGS ACROSS ALL

596
00:23:30,880 --> 00:23:34,680
THREE SITES HAVE ALWAYS MET

597
00:23:34,680 --> 00:23:35,600
FREQUENTLY THROUGHOUT THE TRIAL,

598
00:23:35,600 --> 00:23:40,040
AND I MAKE SURE TO INVITE PEOPLE

599
00:23:40,040 --> 00:23:42,680
ALL THE DIFFERENT PARTS OF THE

600
00:23:42,680 --> 00:23:46,520
TEAM TO COMMUNICATE.

601
00:23:46,520 --> 00:23:47,960
AND SO, FOR EXAMPLE, THE TEAM

602
00:23:47,960 --> 00:23:51,960
THAT WAS DOING THE TECH

603
00:23:51,960 --> 00:23:52,800
ORIENTATIONS FOR THE CLINICAL

604
00:23:52,800 --> 00:23:56,280
TRIAL, THEY WOULD BE GIVING US

605
00:23:56,280 --> 00:23:58,880
VERY USEFUL FEEDBACK, REALLY

606
00:23:58,880 --> 00:24:00,120
REALTIME FEEDBACK, WHAT

607
00:24:00,120 --> 00:24:01,160
PARTICIPANTS NEEDED TO REALLY

608
00:24:01,160 --> 00:24:06,880
LEARN  HOW TO USE TECHNOLOGY.

609
00:24:06,880 --> 00:24:12,360
THIS REALTIME FEEDBACK WAS VERY,

610
00:24:12,360 --> 00:24:13,600
VERY IMPORTANT.

611
00:24:13,600 --> 00:24:16,440
SO, MORE OF THE POLICY LEVEL

612
00:24:16,440 --> 00:24:17,840
LIKE GLORIA WAS TALKING ABOUT

613
00:24:17,840 --> 00:24:19,480
BUT REALLY BEING ABLE TO

614
00:24:19,480 --> 00:24:22,240
ACTUALLY MAKE SURE YEAR

615
00:24:22,240 --> 00:24:28,120
DELIVERING INTERVENTIONS YOU

616
00:24:28,120 --> 00:24:29,560
INTENDED AND THAT IS SIGNALS OF

617
00:24:29,560 --> 00:24:32,480
EARLY RESPONSE THAT IT ACTUALLY

618
00:24:32,480 --> 00:24:33,800
IS WORKING.

619
00:24:33,800 --> 00:24:38,280
SO THOSE ARE SOME BRIEF COMMENTS

620
00:24:38,280 --> 00:24:41,880
HOW WE WERE ABLE TO TAKE

621
00:24:41,880 --> 00:24:46,600
ADVANTAGE OF THE -- OF BOTH

622
00:24:46,600 --> 00:24:47,480
PARTICIPANTS, STAKEHOLDERS, TEAM

623
00:24:47,480 --> 00:24:48,400
ENGAGEMENT DURING A PERIOD OF

624
00:24:48,400 --> 00:24:51,320
TIME WHEN WE HAD TO REALLY DO A

625
00:24:51,320 --> 00:24:56,240
180 HOW OUR INTERVENTION WAS

626
00:24:56,240 --> 00:24:57,400
GOING TO BE DELIVERED.

627
00:24:57,400 --> 00:24:59,400
>> THANK YOU SO MUCH,
NATALIA.

628
00:24:59,400 --> 00:25:05,000
LET'S GO TO OUR THIRD SPEAKER,

629
00:25:05,000 --> 00:25:10,440
DR. CORITA GRUDZEN TO HEAR ABOUT

630
00:25:10,440 --> 00:25:11,280
THE STUDY AND EXPERIENCES.

631
00:25:11,280 --> 00:25:14,000
>> THUMBS UP IF YOU CAN
HEAR

632
00:25:14,000 --> 00:25:14,200
ME.

633
00:25:14,200 --> 00:25:15,200
OKAY, THANK YOU.

634
00:25:15,200 --> 00:25:16,880
SO I'M GOING TO PIVOT A LITTLE

635
00:25:16,880 --> 00:25:18,440
BIT, IT WAS REALLY INTERESTING

636
00:25:18,440 --> 00:25:24,400
TO HEAR FROM BOTH OF YOU.

637
00:25:24,400 --> 00:25:26,560
I GUESS PRIMARY PALLIATIVE CARE

638
00:25:26,560 --> 00:25:29,320
FOR EMERGENCY MEDICINE WAS QUITE

639
00:25:29,320 --> 00:25:30,960
A COMPLEX INTERVENTION, AND SO I

640
00:25:30,960 --> 00:25:34,000
THINK LOOKING FOR A SIGNAL EARLY

641
00:25:34,000 --> 00:25:35,560
IS A VERY COMPLICATED QUESTION

642
00:25:35,560 --> 00:25:37,640
AND I WOULD ARGUE ALMOST

643
00:25:37,640 --> 00:25:37,960
DANGEROUS.

644
00:25:37,960 --> 00:25:40,600
I'LL EXPLAIN WHY.

645
00:25:40,600 --> 00:25:42,800
YOU KNOW, OUR INTERVENTION

646
00:25:42,800 --> 00:25:44,280
INVOLVED MULTIPLE COMPONENTS,

647
00:25:44,280 --> 00:25:45,920
INVOLVED MULTIPLE TARGETS, IT

648
00:25:45,920 --> 00:25:48,040
WAS EMERGENCY PHYSICIANS,

649
00:25:48,040 --> 00:25:49,880
TEACHING EMERGENCY PHYSICIANS,

650
00:25:49,880 --> 00:25:52,200
PRIMARY PALLIATIVE CARE SKILLS,

651
00:25:52,200 --> 00:25:52,680
THERE WERE TECHNOLOGICAL

652
00:25:52,680 --> 00:25:54,480
ENHANCEMENTS TO REMIND THEM.

653
00:25:54,480 --> 00:25:57,880
SO WE TARGETED PHYSICIANS,

654
00:25:57,880 --> 00:26:01,160
APPs, NURSES, SOCIAL WORK.

655
00:26:01,160 --> 00:26:02,320
AND AT MULTIPLE LEVELS SO THE

656
00:26:02,320 --> 00:26:06,320
LEVEL OF THE E.D., LEVEL OF THE

657
00:26:06,320 --> 00:26:06,640
HEALTH SYSTEM.

658
00:26:06,640 --> 00:26:09,960
AND SO BECAUSE OF THIS, I WOULD

659
00:26:09,960 --> 00:26:14,000
SAY LOOKING FOR AN EARLY SIGNAL

660
00:26:14,000 --> 00:26:16,040
IS A LITTLE MORE COMPLEX.

661
00:26:16,040 --> 00:26:17,920
SO I WOULD ARGUE THAT IN OUR

662
00:26:17,920 --> 00:26:22,200
CASE OF COURSE WE -- IT WAS A

663
00:26:22,200 --> 00:26:25,440
UH3 WE PILOTED AT ONE INTERNAL

664
00:26:25,440 --> 00:26:27,440
SITE, ONE EXTERNAL SITE, AND

665
00:26:27,440 --> 00:26:29,840
FOCUSED MAINLY ON IMPLEMENTATION

666
00:26:29,840 --> 00:26:30,480
OUTCOMES, NOT EFFECTIVENESS,

667
00:26:30,480 --> 00:26:32,120
ALTHOUGH THAT COULD BE AN

668
00:26:32,120 --> 00:26:35,760
IMPLEMENTATION OUTCOME BUT WE

669
00:26:35,760 --> 00:26:37,840
FOCUSED ON REALLY MAKING SURE

670
00:26:37,840 --> 00:26:39,240
THAT THE INTERVENTION WAS

671
00:26:39,240 --> 00:26:44,080
FEASIBLE, THAT THERE WAS REACH,

672
00:26:44,080 --> 00:26:46,920
ADOPTION, YOU KNOW, THAT THE

673
00:26:46,920 --> 00:26:47,880
CLINICAL DECISION SUPPORTS TO

674
00:26:47,880 --> 00:26:51,200
IDENTIFY PATIENTS IN NEED OF

675
00:26:51,200 --> 00:26:53,000
PALLIATIVE CARE AND MAYBE PRIOR

676
00:26:53,000 --> 00:26:56,080
ADVANCE DIRECTIVES WERE UP AND

677
00:26:56,080 --> 00:27:00,480
RUNNING BUT WE DIDN'T LOOK AT

678
00:27:00,480 --> 00:27:02,120
SIGNALS FOR PRIMARY OUTCOME

679
00:27:02,120 --> 00:27:06,400
MEASURES ON UTILIZATION AND

680
00:27:06,400 --> 00:27:08,040
SECONDARY MEASURES.

681
00:27:08,040 --> 00:27:10,760
THE REASON IS BECAUSE COMPLEX

682
00:27:10,760 --> 00:27:14,800
INTERVENTIONS REQUIRE SO MUCH

683
00:27:14,800 --> 00:27:16,920
ADAPTATION TO LOCAL CONTEXT THAT

684
00:27:16,920 --> 00:27:19,880
I THINK WHILE OUR IMPLEMENTATION

685
00:27:19,880 --> 00:27:23,080
OUTCOMES WERE GREAT, IF WE HAD

686
00:27:23,080 --> 00:27:25,600
SIMPLY SAID, OKAY, THIS IS --

687
00:27:25,600 --> 00:27:27,960
UPTAKE IS GREAT, WE HAVE REACH,

688
00:27:27,960 --> 00:27:29,360
ADOPTION, I'M NOT SURE THAT

689
00:27:29,360 --> 00:27:31,760
WOULD HAVE TRANSLATED.

690
00:27:31,760 --> 00:27:32,840
NOT ONLY THAT BUT I THINK, YOU

691
00:27:32,840 --> 00:27:38,760
KNOW, IF YOU LOOK AT THE WORK OF

692
00:27:38,760 --> 00:27:42,120
BRIAN MITTMAN, HE WAS PART OF

693
00:27:42,120 --> 00:27:44,920
THE PCORI STANDARDS FOR COMPLEX

694
00:27:44,920 --> 00:27:49,520
INTERVENTIONS, HE ARGUES I THINK

695
00:27:49,520 --> 00:27:52,760
VERY -- IN MY CASE I THINK VERY

696
00:27:52,760 --> 00:27:55,080
WELL THAT THE MORE COMPLEX AN

697
00:27:55,080 --> 00:27:56,680
INTERVENTION, THE LESS LIKELY IT

698
00:27:56,680 --> 00:27:58,800
IS TO WORK ACROSS THE BOARD.

699
00:27:58,800 --> 00:28:01,320
AND THE QUESTION IS NOT WILL IT

700
00:28:01,320 --> 00:28:02,960
WORK ON AVERAGE ACROSS ALL OF

701
00:28:02,960 --> 00:28:05,560
THE HEALTH SYSTEMS BUT IN WHAT

702
00:28:05,560 --> 00:28:08,640
LOCAL CONTEXT DOES IT WORK AND

703
00:28:08,640 --> 00:28:09,040
WHY.

704
00:28:09,040 --> 00:28:11,800
AND I THINK WE MAKE A MISTAKE TO

705
00:28:11,800 --> 00:28:15,200
THINK AND TO SORT OF HAVE AN

706
00:28:15,200 --> 00:28:17,080
APPROACH THAT ASSUMES IT'S A YES

707
00:28:17,080 --> 00:28:20,840
OR NO ANSWER AND REALLY IT'S ALL

708
00:28:20,840 --> 00:28:21,760
ABOUT CONTEXT.

709
00:28:21,760 --> 00:28:24,920
AND SO WE WERE AT THE STAGE THAT

710
00:28:24,920 --> 00:28:27,000
WE HAVE ALL OF OUR FINAL DATA,

711
00:28:27,000 --> 00:28:31,600
TO LOOK AT OUR OUTCOMES.

712
00:28:31,600 --> 00:28:40,960
WE'VE, YOU KNOW, AD NAUSEAM

713
00:28:40,960 --> 00:28:43,560
PUBLISHED OUTCOME OUTCOMES,

714
00:28:43,560 --> 00:28:44,480
QUANTITATIVE AND QUALITATIVE

715
00:28:44,480 --> 00:28:48,440
WAYS BUT EFFECT WHICH EFFECT

716
00:28:48,440 --> 00:28:50,280
HEALTH CARE UTILIZATION WILL BE

717
00:28:50,280 --> 00:28:52,680
MUCH MORE CHALLENGING TO

718
00:28:52,680 --> 00:28:54,480
UNDERSTAND AND -- NOT TO

719
00:28:54,480 --> 00:28:55,840
UNDERSTAND BUT I THINK WILL

720
00:28:55,840 --> 00:28:58,360
BE -- THERE WILL BE A LOT MORE

721
00:28:58,360 --> 00:29:01,240
HETEROGENEITY IN TERMS OF HOW

722
00:29:01,240 --> 00:29:02,440
THEY IMPACT PATIENT OUTCOMES.

723
00:29:02,440 --> 00:29:05,920
AND PROBABLY A LOT OF THAT WILL

724
00:29:05,920 --> 00:29:06,800
RELATE TO LOCAL LEADERSHIP, YOU

725
00:29:06,800 --> 00:29:09,640
KNOW, A HOST OF FACTORS.

726
00:29:09,640 --> 00:29:11,520
PROBABLY MOST IMPORTANTLY THE

727
00:29:11,520 --> 00:29:14,360
PANDEMIC, BECAUSE WE HAD TO STOP

728
00:29:14,360 --> 00:29:16,040
RECRUITMENT OR STOP OUR -- IT'S

729
00:29:16,040 --> 00:29:18,200
A STEPPED WEDGE, HAD TO PAUSE

730
00:29:18,200 --> 00:29:22,720
FOR SIX MONTHS. 

731
00:29:22,720 --> 00:29:26,160
SO, I I DON'T HAVE MUCH ELSE TO

732
00:29:26,160 --> 00:29:29,240
SAY SO I'LL LEAVE MORE TIME FOR

733
00:29:29,240 --> 00:29:30,120
DISCUSSION.

734
00:29:30,120 --> 00:29:31,600
THAT'S MY MAIN POINT.

735
00:29:31,600 --> 00:29:33,520
>> THANK YOU SO MUCH.

736
00:29:33,520 --> 00:29:35,720
I WANT TO FIRST BEGIN BY ASKING

737
00:29:35,720 --> 00:29:38,240
THE THREE OF YOU, ASK THERE

738
00:29:38,240 --> 00:29:39,400
ANYTHING THE OTHERS SAID THAT

739
00:29:39,400 --> 00:29:40,840
MADE YOU THINK OF SOMETHING ELSE

740
00:29:40,840 --> 00:29:45,120
YOU WANTED TO ADD OR COMMENT ON

741
00:29:45,120 --> 00:29:49,720
ABOUT THE OTHER TRIALS? 

742
00:29:49,720 --> 00:29:52,120
WE HAD SOME COMMON THEMES, BUT

743
00:29:52,120 --> 00:29:54,200
ANYTHING -- ANYONE WANT TO ADD

744
00:29:54,200 --> 00:29:56,160
BEFORE WE GO FOR DISCUSSION?

745
00:29:56,160 --> 00:29:59,680
>> I'LL JUST SAY I RELATE
TO

746
00:29:59,680 --> 00:30:01,000
THE CYCLE.

747
00:30:01,000 --> 00:30:02,840
IT'S A DIFFERENT ISSUE.

748
00:30:02,840 --> 00:30:04,120
I LOVED HEARING ABOUT THAT

749
00:30:04,120 --> 00:30:07,000
BECAUSE I THINK THAT'S KEY TO

750
00:30:07,000 --> 00:30:08,560
FIGURING OUT HOW TO EVEN --

751
00:30:08,560 --> 00:30:09,200
BEFORE YOU EVALUATE THE

752
00:30:09,200 --> 00:30:11,080
INTERVENTION YOU HAVE TO FIGURE

753
00:30:11,080 --> 00:30:12,720
OUT WHAT ALL OF THE PAINFUL

754
00:30:12,720 --> 00:30:15,840
POINTS ARE THAT NEED TO BE

755
00:30:15,840 --> 00:30:16,040
FIXED.

756
00:30:16,040 --> 00:30:20,280
SO I RELATE.

757
00:30:20,280 --> 00:30:26,280
>> THAT'S A GOOD PLACE TO
START

758
00:30:26,280 --> 00:30:27,720
A DISCUSSION.

759
00:30:27,720 --> 00:30:30,560
YESTERDAY HAYDEN BOSWORTH IN HIS

760
00:30:30,560 --> 00:30:32,640
SUMMARY HAD A REALLY INTERESTING

761
00:30:32,640 --> 00:30:35,160
QUESTION WHICH WAS WHEN IS IT

762
00:30:35,160 --> 00:30:37,560
TIME TO STOP ADAPTING AND JUST

763
00:30:37,560 --> 00:30:37,880
STOP?

764
00:30:37,880 --> 00:30:41,000
AND SO IN THESE TRIALS WHERE

765
00:30:41,000 --> 00:30:42,960
THERE'S THE INTENTION TO

766
00:30:42,960 --> 00:30:49,720
EXPLICITLY MONITOR IN REAL TIME

767
00:30:49,720 --> 00:30:52,360
AND MAKE LOCAL ADJUSTMENTS, HOW

768
00:30:52,360 --> 00:30:56,080
DO YOU THINK ABOUT WHEN FURTHER

769
00:30:56,080 --> 00:30:58,880
ADAPTATIONS ARE NOT GOING TO BE

770
00:30:58,880 --> 00:31:00,120
USEFUL OR DO YOU?

771
00:31:00,120 --> 00:31:08,920
HOW DO WE FIGURE THAT OUT? 

772
00:31:08,920 --> 00:31:11,520
>> THIS IS GLORIA.

773
00:31:11,520 --> 00:31:13,040
SUCH A GOOD QUESTION.

774
00:31:13,040 --> 00:31:14,680
I ACTUALLY DON'T KNOW IF IT'S

775
00:31:14,680 --> 00:31:17,320
GOING TO BE THE SAME ANSWER FOR

776
00:31:17,320 --> 00:31:18,960
EVERY PROJECT OR EVERY SCENARIO

777
00:31:18,960 --> 00:31:21,680
BECAUSE I THINK IT'S GOING TO

778
00:31:21,680 --> 00:31:23,680
BE -- IT'S GOING TO REALLY

779
00:31:23,680 --> 00:31:25,200
DEPEND ON CONTEXT BUT IT'S

780
00:31:25,200 --> 00:31:27,160
SOMETHING WE'VE THOUGHT A LOT

781
00:31:27,160 --> 00:31:29,040
ABOUT, BECAUSE THERE'S SOME

782
00:31:29,040 --> 00:31:31,440
CLINICS THAT WILL TAKE ON AN

783
00:31:31,440 --> 00:31:32,240
INTERVENTION WITH GUSTO, AND

784
00:31:32,240 --> 00:31:33,840
THEN THEY WILL LOOK AT THE

785
00:31:33,840 --> 00:31:34,920
FINDINGS AND SAY, WELL, THIS

786
00:31:34,920 --> 00:31:38,120
ISN'T WHAT I EXPECTED.

787
00:31:38,120 --> 00:31:40,200
I EXPECTED TO SEE A, YOU KNOW, A

788
00:31:40,200 --> 00:31:41,960
60% INCREASE IN THIS OUTCOME AND

789
00:31:41,960 --> 00:31:44,800
I GOT A 10 OR 12%.

790
00:31:44,800 --> 00:31:46,720
AND THEN THEY WILL ABANDON THE

791
00:31:46,720 --> 00:31:47,160
EFFORT.

792
00:31:47,160 --> 00:31:48,800
THERE ARE OTHER CLINICS THAT

793
00:31:48,800 --> 00:31:50,640
MIGHT TAKE A MORE KIND OF

794
00:31:50,640 --> 00:31:52,520
MEASURED APPROACH AND REALLY

795
00:31:52,520 --> 00:31:54,040
THINK ABOUT HOW THEY CAN DESIGN

796
00:31:54,040 --> 00:31:56,560
THE STUDY SO THEY CAN CLAIM SOME

797
00:31:56,560 --> 00:31:58,440
EARLY SUCCESS, AND BUILD ON THAT

798
00:31:58,440 --> 00:32:00,400
MOMENTUM AND EXPAND OUT FURTHER.

799
00:32:00,400 --> 00:32:02,480
AND SO I DO SEE, YOU KNOW,

800
00:32:02,480 --> 00:32:04,000
CLINICS TAKING VERY DIFFERENT

801
00:32:04,000 --> 00:32:06,280
APPROACHES AND I CERTAINLY THINK

802
00:32:06,280 --> 00:32:07,720
THAT THE MORE MEASURED APPROACH

803
00:32:07,720 --> 00:32:12,880
TENDS TO BE ONE THAT PERHAPS IS

804
00:32:12,880 --> 00:32:14,960
PLANNING FOR LONGER TERM

805
00:32:14,960 --> 00:32:15,320
IMPLEMENTATION.

806
00:32:15,320 --> 00:32:18,240
I THINK I MEAN WE HEAR A LOT

807
00:32:18,240 --> 00:32:18,880
ABOUT PLANNING FOR

808
00:32:18,880 --> 00:32:21,080
SUSTAINABILITY AT THE VERY

809
00:32:21,080 --> 00:32:23,280
BEGINNING, WHICH I THINK DOES

810
00:32:23,280 --> 00:32:24,920
MAKE ME THINK HOW DO DO YOU

811
00:32:24,920 --> 00:32:26,800
SOMETHING SMALL AND THEN EXPAND

812
00:32:26,800 --> 00:32:30,640
IT OUT VERSUS GOING ALL IN AND

813
00:32:30,640 --> 00:32:39,280
POTENTIALLY ABANDONING THE

814
00:32:39,280 --> 00:32:45,160
EFFORT LATER.

815
00:32:45,160 --> 00:32:45,480
>> THANKS.

816
00:32:45,480 --> 00:32:48,280
>> THIS IS AN INTERESTING
ONE.

817
00:32:48,280 --> 00:32:49,600
PRAGMATIC TRIALS WE'RE WORKING

818
00:32:49,600 --> 00:32:51,120
WITH EVIDENCE-BASED MEDICINE SO

819
00:32:51,120 --> 00:32:53,760
TRYING TO PUT FORWARD EVIDENCE

820
00:32:53,760 --> 00:32:54,360
BASE.

821
00:32:54,360 --> 00:32:56,360
SO, THAT'S WHY IT'S A TRICKY

822
00:32:56,360 --> 00:32:59,840
QUESTION BECAUSE IT'S LIKE

823
00:32:59,840 --> 00:33:02,680
SAYING, YOU KNOW, WE WANT TO PUT

824
00:33:02,680 --> 00:33:05,320
FORWARD SOME TYPE OF WALL TO

825
00:33:05,320 --> 00:33:08,080
MAKING THAT EVIDENCE GO FORWARD

826
00:33:08,080 --> 00:33:09,160
AND REALLY GETTING IT

827
00:33:09,160 --> 00:33:09,800
IMPLEMENTED.

828
00:33:09,800 --> 00:33:12,880
SO I THINK THAT'S WHY -- WHAT

829
00:33:12,880 --> 00:33:15,920
I'VE HEARD IS HOW ALL OF US

830
00:33:15,920 --> 00:33:18,480
WORKED HARD AT SHIFTING SO THAT

831
00:33:18,480 --> 00:33:21,120
WE DON'T HAVE TO GIVE UP THE

832
00:33:21,120 --> 00:33:25,120
GHOST, SO TO SPEAK.

833
00:33:25,120 --> 00:33:27,640
SO I THINK THAT OUR SIGNALS

834
00:33:27,640 --> 00:33:28,960
THOUGH THAT POTENTIALLY IT NEEDS

835
00:33:28,960 --> 00:33:32,800
TO CHANGE, AND THIS IS WHY I

836
00:33:32,800 --> 00:33:35,960
LOVE GLORIA SAYING THE PDSA

837
00:33:35,960 --> 00:33:38,360
CYCLE, REMINDS ME OF RESIDENCY

838
00:33:38,360 --> 00:33:39,880
WHERE THAT'S A REQUIREMENT, I'M

839
00:33:39,880 --> 00:33:42,480
AN INTERNIST, THAT WE DO THAT.

840
00:33:42,480 --> 00:33:44,080
AND IT'S VERY USEFUL IN THE

841
00:33:44,080 --> 00:33:47,320
CLINIC AND IT'S ACTUALLY A

842
00:33:47,320 --> 00:33:49,280
MINDSET THAT PRIMARY CARE

843
00:33:49,280 --> 00:33:50,400
PROVIDERS WILL UNDERSTAND, IF

844
00:33:50,400 --> 00:33:51,800
YOU APPROACH THE CLINIC WITH

845
00:33:51,800 --> 00:33:52,240
THAT.

846
00:33:52,240 --> 00:33:55,000
SO, I THINK PART OF IT IS SOME

847
00:33:55,000 --> 00:33:57,760
OF THE ADAPTATIONS MAY BE MORE

848
00:33:57,760 --> 00:34:00,640
THAN WE HAVE EXPECTED.

849
00:34:00,640 --> 00:34:01,920
EVIDENCE BASE MIGHT HAVE THE

850
00:34:01,920 --> 00:34:04,000
IMPLEMENTATION ONE WAY AND WE'RE

851
00:34:04,000 --> 00:34:04,880
GOING TO POTENTIALLY BE CHANGING

852
00:34:04,880 --> 00:34:07,480
IT A LOT MORE THAN EXPECTED.

853
00:34:07,480 --> 00:34:10,040
I THINK THAT'S ONLY FAIR GIVEN

854
00:34:10,040 --> 00:34:11,440
THE HETEROGENEITY OF EACH OF THE

855
00:34:11,440 --> 00:34:13,520
CLINICS THAT WE'VE TALKED ABOUT.

856
00:34:13,520 --> 00:34:17,320
SO, SOMETIMES I WONDER HOW MUCH

857
00:34:17,320 --> 00:34:18,680
IS ACTUALLY STOPPING, THIS IS

858
00:34:18,680 --> 00:34:24,880
REALLY MAKING A CHANGE, THAT

859
00:34:24,880 --> 00:34:29,000
WASN'T THE ORIGINAL RANDOMIZED

860
00:34:29,000 --> 00:34:29,400
CONTROLLED TRIAL.

861
00:34:29,400 --> 00:34:35,600
>> YEAH, THAT TERM

862
00:34:35,600 --> 00:34:37,800
HETEROGENEITY WAS ONE CORITA

863
00:34:37,800 --> 00:34:39,120
USED A FEW MINUTES AGO.

864
00:34:39,120 --> 00:34:43,600
FOR FOLKS NOT USED TO THINKING

865
00:34:43,600 --> 00:34:44,880
ABOUT PRAGMATIC TRIALS

866
00:34:44,880 --> 00:34:47,200
ESPECIALLY INVOLVING COMPLEX

867
00:34:47,200 --> 00:34:50,240
INTERVENTIONS IT MAY STRIKE

868
00:34:50,240 --> 00:34:52,480
PEOPLE AS WEIRD THE ABILITY TO

869
00:34:52,480 --> 00:34:55,400
ADAPT LOCALLY IN WAYS NOW THAT

870
00:34:55,400 --> 00:35:00,680
IT'S DIFFICULT TO SAY WHAT THE

871
00:35:00,680 --> 00:35:02,400
INTERVENTION IS, APART FROM AN

872
00:35:02,400 --> 00:35:03,040
EXPLICIT PROCESS PEOPLE SHOULD

873
00:35:03,040 --> 00:35:04,520
GO THROUGH TO FIGURE OUT WHAT'S

874
00:35:04,520 --> 00:35:07,000
GOING TO HAPPEN LOCALLY.

875
00:35:07,000 --> 00:35:09,200
I THOUGHT IT WAS INTERESTING

876
00:35:09,200 --> 00:35:10,160
CORITA, YOU WERE SAYING THAT

877
00:35:10,160 --> 00:35:12,800
WHEN IT COMES TO LOOKING AT THE

878
00:35:12,800 --> 00:35:16,640
BIG PRIMARY AND SECONDARY

879
00:35:16,640 --> 00:35:19,840
EFFICACY ENDPOINTS, IT MIGHT BE

880
00:35:19,840 --> 00:35:20,960
CHALLENGING NOW BECAUSE YOU'RE

881
00:35:20,960 --> 00:35:23,240
ASSUMING THERE'S GOING TO BE

882
00:35:23,240 --> 00:35:24,080
HETEROGENEITY THERE.

883
00:35:24,080 --> 00:35:27,160
AND I GUESS A PROVOCATIVE

884
00:35:27,160 --> 00:35:29,680
QUESTION MIGHT BE IS THIS

885
00:35:29,680 --> 00:35:31,000
HETEROGENEITY OF TREATMENT

886
00:35:31,000 --> 00:35:31,560
EFFECTIVE A WELL-DEFINED

887
00:35:31,560 --> 00:35:40,200
TREATMENT OR TO WHAT EXTENT ARE

888
00:35:40,200 --> 00:35:42,080
WE ACTUALLY DOCUMENTING EFFECTS

889
00:35:42,080 --> 00:35:42,600
OF DIFFERENT TREATMENTS.

890
00:35:42,600 --> 00:35:45,240
>> I THINK IT'S THE
LATTER,

891
00:35:45,240 --> 00:35:45,600
UNFORTUNATELY.

892
00:35:45,600 --> 00:35:47,760
I WISH IT WAS SIMPLER AND WE

893
00:35:47,760 --> 00:35:50,840
WERE JUST -- THERE WAS JUST

894
00:35:50,840 --> 00:35:51,800
HETEROGENEITY OF TREATMENT

895
00:35:51,800 --> 00:35:53,760
EFFECT, YOU KNOW, BUT I THINK

896
00:35:53,760 --> 00:35:56,880
IT'S UNFORTUNATELY MORE

897
00:35:56,880 --> 00:35:58,080
COMPLICATED THAN THAT.

898
00:35:58,080 --> 00:35:59,040
THE BEER VENGES IS BY NATURE

899
00:35:59,040 --> 00:36:02,120
GOING TO BE A LITTLE BIT

900
00:36:02,120 --> 00:36:03,560
DIFFERENT, OR IT'S NOT -- THE

901
00:36:03,560 --> 00:36:05,920
INTERVENTION IS GOING TO BE

902
00:36:05,920 --> 00:36:13,480
DIFFERENT OR IF YOU HAVE COMPLEX

903
00:36:13,480 --> 00:36:16,400
INTERVENTION, YOU DON'T ADAPT

904
00:36:16,400 --> 00:36:18,600
IT, YOU'RE TOAST.

905
00:36:18,600 --> 00:36:29,120
>> YEAH, I THINK THAT'S
-- IT

906
00:36:29,880 --> 00:36:31,880
REALLY MAKES IT FUZZY TALKING

907
00:36:31,880 --> 00:36:33,080
ABOUT EARLY SIGNALS THE

908
00:36:33,080 --> 00:36:34,600
INTERVENTION MIGHT NOT WORK,

909
00:36:34,600 --> 00:36:35,560
INTERPRETED DIFFERENTLY, IN A

910
00:36:35,560 --> 00:36:36,560
SITUATION LIKE THIS WHERE IT'S

911
00:36:36,560 --> 00:36:41,600
PART OF THE INTERVENTION TO DO

912
00:36:41,600 --> 00:36:43,360
THESE ADAPTATIONS AND SO THAT

913
00:36:43,360 --> 00:36:45,640
RAISES THAT QUESTION ABOUT AT

914
00:36:45,640 --> 00:36:53,000
WHAT POINT DO YOU SAY WE CAN'T

915
00:36:53,000 --> 00:36:56,040
ITERATE  FURTHER, ITERATING

916
00:36:56,040 --> 00:36:58,280
FURTHER SEEMS TO BE FRUITLESS,

917
00:36:58,280 --> 00:37:00,320
SEEMS LIKE THAT'S AN INTERESTING

918
00:37:00,320 --> 00:37:06,520
BUT CHALLENGING DECISION POINT

919
00:37:06,520 --> 00:37:07,000
TO CONSIDER.

920
00:37:07,000 --> 00:37:10,240
>> YEAH, I MEAN, I WAS

921
00:37:10,240 --> 00:37:12,520
STRUGGLING, I STRUGGLE WITH

922
00:37:12,520 --> 00:37:15,280
THAT, YOU KNOW, DO YOU KEEP

923
00:37:15,280 --> 00:37:15,600
ADAPTING?

924
00:37:15,600 --> 00:37:18,000
BUT I THINK IN MY MIND THE MOST

925
00:37:18,000 --> 00:37:19,960
IMPORTANT THING IS JUST FOCUSING

926
00:37:19,960 --> 00:37:23,120
ON IMPLEMENTATION AND JUST

927
00:37:23,120 --> 00:37:24,240
KEEPING THOSE IMPLEMENTATION

928
00:37:24,240 --> 00:37:26,960
OUTCOMES IN MIND BECAUSE IF YOU

929
00:37:26,960 --> 00:37:28,920
PASS OVER THAT, THEN WHAT IN THE

930
00:37:28,920 --> 00:37:31,160
WORLD ARE YOU DOING, WHAT ARE

931
00:37:31,160 --> 00:37:33,640
YOU TESTING, BECAUSE YOU'RE NOT,

932
00:37:33,640 --> 00:37:37,280
YOU KNOW, AND AS LONG AS YOU ARE

933
00:37:37,280 --> 00:37:38,680
RELIGIOUS ABOUT THE FUNCTIONS OF

934
00:37:38,680 --> 00:37:40,080
THE INTERVENTION, THAT'S WHERE

935
00:37:40,080 --> 00:37:45,720
THE FORM FUNCTION COMES IN, I

936
00:37:45,720 --> 00:37:47,360
THINK PRE-SPECIFYING WHAT THE

937
00:37:47,360 --> 00:37:50,080
FUNCTIONS ARE, OURS WERE

938
00:37:50,080 --> 00:37:52,800
IDENTIFYING PATIENTS WITH

939
00:37:52,800 --> 00:37:55,440
SERIOUS ILLNESS WITH PALLIATIVE

940
00:37:55,440 --> 00:37:56,880
CARE NEEDS, ADVANCE LIFE

941
00:37:56,880 --> 00:37:58,760
DIRECTORS, ACTING ON THOSE PER

942
00:37:58,760 --> 00:38:00,480
THE PATIENT'S WISHES, THOSE WERE

943
00:38:00,480 --> 00:38:01,240
THE FUNCTIONS.

944
00:38:01,240 --> 00:38:03,000
THE FORMS THEY MIGHT TAKE,

945
00:38:03,000 --> 00:38:07,240
WHETHER IT'S A BANNER OR

946
00:38:07,240 --> 00:38:08,600
INTERRUPTIVE ALERT, LIKE SOME

947
00:38:08,600 --> 00:38:10,480
HEALTH SYSTEMS DID NOT USE

948
00:38:10,480 --> 00:38:11,440
INTERRUPTIVE ALERTS.

949
00:38:11,440 --> 00:38:12,440
THERE WAS A NON-STARTER.

950
00:38:12,440 --> 00:38:15,560
THEY DIDN'T DO IT.

951
00:38:15,560 --> 00:38:17,760
OTHER ONES, THEY LOVED IT.

952
00:38:17,760 --> 00:38:21,160
WE CAN'T IMPOSE OUR WILL AND SAY

953
00:38:21,160 --> 00:38:23,360
YOU HAVE TO HAVE AN INTERRUPTIVE

954
00:38:23,360 --> 00:38:23,640
ALERT.

955
00:38:23,640 --> 00:38:29,800
I JUST PUT IT IN THE BANNER,

956
00:38:29,800 --> 00:38:31,120
WHATEVER THE LOCAL CONTEXT IS.

957
00:38:31,120 --> 00:38:37,640
AS LONG AS YOU'RE FOCUSED ON THE

958
00:38:37,640 --> 00:38:40,040
FORMS IS, YEAH, THE WAY TO MAKE

959
00:38:40,040 --> 00:38:42,280
SURE YOU'RE I GUESS KEEPING WITH

960
00:38:42,280 --> 00:38:51,440
THE PURPOSE OF THE WHOLE

961
00:38:51,440 --> 00:38:51,760
INTERVENTION.

962
00:38:51,760 --> 00:38:53,920
>> THIS IS GLORIA, TO ADD
TO

963
00:38:53,920 --> 00:38:55,720
THE CONVERSATION, IN OUR CASE

964
00:38:55,720 --> 00:38:58,200
THERE WAS QUITE A BIT OF

965
00:38:58,200 --> 00:39:00,400
EVIDENCE MAIL KIT OUTREACH WAS A

966
00:39:00,400 --> 00:39:01,240
SUCCESSFUL INTERVENTION.

967
00:39:01,240 --> 00:39:04,800
I FEEL AS IF PART OF WHAT I

968
00:39:04,800 --> 00:39:07,000
NOTICED IS THAT AMONG THE

969
00:39:07,000 --> 00:39:08,600
COLLABORATORY-FUNDED PROJECTS

970
00:39:08,600 --> 00:39:12,200
THERE WAS A CONTINUUM, A RANGE

971
00:39:12,200 --> 00:39:17,680
AT WHICH THEY WERE EMPHASIZING

972
00:39:17,680 --> 00:39:18,720
EFFICACY VERSUS IMPLEMENTATION,

973
00:39:18,720 --> 00:39:20,640
OUR PROJECT WAS PERHAPS MORE ON

974
00:39:20,640 --> 00:39:22,080
THE IMPLEMENTATION END BECAUSE

975
00:39:22,080 --> 00:39:23,720
WE DIDN'T NECESSARILY NEED TO

976
00:39:23,720 --> 00:39:26,280
PROVE IT WOULD WORK AS A WHOLE.

977
00:39:26,280 --> 00:39:27,760
WHAT WE NEEDED TO REALLY

978
00:39:27,760 --> 00:39:29,160
DEMONSTRATE OR WE WANTED TO

979
00:39:29,160 --> 00:39:30,920
DEMONSTRATE IS THAT THIS COULD

980
00:39:30,920 --> 00:39:31,920
WORK IN MULTIPLE SETTINGS, IT

981
00:39:31,920 --> 00:39:33,440
MIGHT NEED TO BE ADAPTED FOR

982
00:39:33,440 --> 00:39:35,080
THOSE SETTINGS BUT IT COULD WORK

983
00:39:35,080 --> 00:39:39,680
IN THESE SAFETY NET CLINICS,

984
00:39:39,680 --> 00:39:40,120
RIGHT?

985
00:39:40,120 --> 00:39:43,640
AND SO WHAT WE LEARNED THROUGH

986
00:39:43,640 --> 00:39:45,160
THE PROCESS, AGAIN, IS IT

987
00:39:45,160 --> 00:39:47,560
WASN'T -- THERE WERE A LOT MORE

988
00:39:47,560 --> 00:39:49,960
QUESTIONS THAT WERE PUT ON THE

989
00:39:49,960 --> 00:39:52,480
TABLE, LIKE DURING THE PDSA

990
00:39:52,480 --> 00:39:54,560
APPROACH THERE WAS ONE CLINIC

991
00:39:54,560 --> 00:39:56,760
THAT SAID, WELL, WE DON'T WANT

992
00:39:56,760 --> 00:39:58,000
TO LOOK BACK TO IDENTIFY

993
00:39:58,000 --> 00:39:59,440
PATIENTS WITH A CLINIC VISIT IN

994
00:39:59,440 --> 00:40:00,640
THE LAST YEAR, WE WANT TO JUST

995
00:40:00,640 --> 00:40:03,000
LOOK BACK AT THE LAST TWO MONTHS

996
00:40:03,000 --> 00:40:04,880
AND MAIL OUT TO THOSE PATIENTS

997
00:40:04,880 --> 00:40:06,560
WHO WEREN'T GIVEN ONE DURING THE

998
00:40:06,560 --> 00:40:07,760
CLINIC VISIT.

999
00:40:07,760 --> 00:40:10,080
IT'S LIKE A SWEEP OF THOSE

1000
00:40:10,080 --> 00:40:11,840
PATIENTS WHO WERE ESSENTIALLY

1001
00:40:11,840 --> 00:40:12,400
MISSED.

1002
00:40:12,400 --> 00:40:14,600
AND SO IT'S REALLY -- IT WAS AN

1003
00:40:14,600 --> 00:40:16,720
INTERESTING IDEA ABOUT HOW YOU

1004
00:40:16,720 --> 00:40:19,720
CAN ADAPT THE PROGRAM TO PERHAPS

1005
00:40:19,720 --> 00:40:21,680
GET EVEN HIGHER RETURN RATE

1006
00:40:21,680 --> 00:40:23,760
BECAUSE THESE PATIENTS HAVE HAD

1007
00:40:23,760 --> 00:40:26,280
A RECENT CONTACT WITH THE

1008
00:40:26,280 --> 00:40:27,920
CLINIC, TYPICALLY HAVE GOOD

1009
00:40:27,920 --> 00:40:29,120
CONTACT INFORMATION IN THE

1010
00:40:29,120 --> 00:40:30,480
ELECTRONIC HEALTH RECORD, JUST

1011
00:40:30,480 --> 00:40:34,480
HAD A VISIT, SO TO SEND A LETTER

1012
00:40:34,480 --> 00:40:39,560
THAT SAYS, OOPS, WE FORGOT TO

1013
00:40:39,560 --> 00:40:50,040
GIVE YOU A TEST, MAIL IT BACK,

1014
00:40:50,320 --> 00:40:51,240
WAS FEDERALLY QUALIFIED CLINICS

1015
00:40:51,240 --> 00:40:52,240
MAY CLAIM EARLY SUCCESS IF

1016
00:40:52,240 --> 00:40:53,960
BUILDING OVER TIME OR KEEPING IT

1017
00:40:53,960 --> 00:40:57,560
A SMALL SCALE IF THAT'S WHAT BEE

1018
00:40:57,560 --> 00:40:59,680
NEED TO DO OR ANY NEED TO BE

1019
00:40:59,680 --> 00:41:00,880
FILLED THERE'S TYPICALLY A WAY

1020
00:41:00,880 --> 00:41:02,280
TO ADAPT THE PROGRAM TO MAKE IT

1021
00:41:02,280 --> 00:41:02,600
WORK.

1022
00:41:02,600 --> 00:41:04,240
I THINK THAT'S SOME OF THE MOST

1023
00:41:04,240 --> 00:41:06,200
VALUABLE FINDINGS FROM OUR WORK

1024
00:41:06,200 --> 00:41:09,040
IS REALLY WHAT ARE THOSE PLACES

1025
00:41:09,040 --> 00:41:10,240
WHERE THINGS CAN GO OFF THE

1026
00:41:10,240 --> 00:41:11,680
RAILS OR THINGS THAT YOU NEED TO

1027
00:41:11,680 --> 00:41:14,760
PAY ATTENTION TO IN ORDER TO

1028
00:41:14,760 --> 00:41:16,800
SUCCESSFULLY IMPLEMENT THIS

1029
00:41:16,800 --> 00:41:17,840
PROGRAM.

1030
00:41:17,840 --> 00:41:20,400
>> I REALLY APPRECIATE
BOTH

1031
00:41:20,400 --> 00:41:24,400
YOUR COMMENTS, AND I WANT TO

1032
00:41:24,400 --> 00:41:26,800
UNDERCORE ALSO WHAT CORITA SAID,

1033
00:41:26,800 --> 00:41:27,960
THERE'S A DIFFERENCE BETWEEN

1034
00:41:27,960 --> 00:41:29,080
WHAT'S AT THE CORE AT WHAT YOU

1035
00:41:29,080 --> 00:41:32,960
WANT TO DELIVER AND WHAT'S THE

1036
00:41:32,960 --> 00:41:33,440
ADAPTATION.

1037
00:41:33,440 --> 00:41:34,760
SO, YOU KNOW, THE ANALOGY, YOU

1038
00:41:34,760 --> 00:41:38,280
KNOW, IS IF YOU'RE TRYING TO GET

1039
00:41:38,280 --> 00:41:39,920
GLORIA, PEOPLE, TO GET THEIR

1040
00:41:39,920 --> 00:41:41,120
SCREENING DONE, HOW YOU REACH

1041
00:41:41,120 --> 00:41:43,400
THEM, WHETHER YOU DO IT BY MAIL,

1042
00:41:43,400 --> 00:41:50,000
BY PHONE, WHETHER YOU SEND  A

1043
00:41:50,000 --> 00:41:51,400
TEXT, THAT'S THE ADAPTATION.

1044
00:41:51,400 --> 00:41:53,440
WHETHER YOU DO IT OVER THE PAST

1045
00:41:53,440 --> 00:41:55,040
TWO, THAT IS NOT GOING TO

1046
00:41:55,040 --> 00:41:56,000
COMPROMISE THE CORE OF WHAT

1047
00:41:56,000 --> 00:41:58,040
YOU'RE TRYING TO DO.

1048
00:41:58,040 --> 00:42:02,000
I JUST WANTED TO UNDERSCORE

1049
00:42:02,000 --> 00:42:03,280
BECAUSE THERE'S A DIFFERENCE

1050
00:42:03,280 --> 00:42:04,400
BETWEEN THE TWO.

1051
00:42:04,400 --> 00:42:07,720
AS INVESTIGATORS WE HAVE TO KEEP

1052
00:42:07,720 --> 00:42:10,880
THAT IN MIND AND NOT FORGET

1053
00:42:10,880 --> 00:42:13,080
THAT, WHAT IS IT THAT WE'RE

1054
00:42:13,080 --> 00:42:16,000
TRYING TO ACTUALLY DO VERSUS

1055
00:42:16,000 --> 00:42:20,720
WHAT ARE THE ADAPTATIONS, THAT'S

1056
00:42:20,720 --> 00:42:22,240
A REALLY NICE POINT.

1057
00:42:22,240 --> 00:42:26,600
>> I SEE A COMMENT FROM
KEVIN

1058
00:42:26,600 --> 00:42:28,240
CHAN AT NIDDK WHO AGREES WITH

1059
00:42:28,240 --> 00:42:30,800
THE ISSUE OF FORM AND FUNCTION

1060
00:42:30,800 --> 00:42:32,080
AND KEVIN SAYS IT'S IMPORTANT

1061
00:42:32,080 --> 00:42:34,160
THAT YOU CAN DESCRIBE YOUR

1062
00:42:34,160 --> 00:42:34,760
INTERVENTION AS PRECISELY AS

1063
00:42:34,760 --> 00:42:37,040
POSSIBLE SO IT COULD BE

1064
00:42:37,040 --> 00:42:41,480
REPLICATED IN OTHER CENTERS

1065
00:42:41,480 --> 00:42:42,800
ACROSS THE U.S.

1066
00:42:42,800 --> 00:42:45,000
GREG SIMON HAD A QUESTION ABOUT

1067
00:42:45,000 --> 00:42:47,400
SIGNAL TO NOISE, SIGNAL VERSUS

1068
00:42:47,400 --> 00:42:47,600
NOISE.

1069
00:42:47,600 --> 00:42:51,000
GREG, DO YOU WANT TO POSE YOUR

1070
00:42:51,000 --> 00:42:51,280
QUESTION?

1071
00:42:51,280 --> 00:42:51,680
>> SURE.

1072
00:42:51,680 --> 00:42:54,280
IT'S SOMETHING I'VE BEEN

1073
00:42:54,280 --> 00:42:57,000
THINKING ABOUT BUT GLORIA'S

1074
00:42:57,000 --> 00:42:58,640
POINT ABOUT CO-PAYMENTS FOR

1075
00:42:58,640 --> 00:43:00,600
COLONOSCOPY IS A NICE EXAMPLE OF

1076
00:43:00,600 --> 00:43:03,400
WHEN YOU RUN INTO A BARRIER HOW

1077
00:43:03,400 --> 00:43:05,600
DO YOU DECIDE WHETHER THIS

1078
00:43:05,600 --> 00:43:06,640
BARRIER IS AN ARTIFICIAL THING,

1079
00:43:06,640 --> 00:43:08,960
WHICH SHOULD BE AT LEAST IN THE

1080
00:43:08,960 --> 00:43:12,360
CONTEXT OF THE TRIAL REMOVED

1081
00:43:12,360 --> 00:43:14,640
BECAUSE IT'S NOISE, VERSUS THIS

1082
00:43:14,640 --> 00:43:16,200
BARRIER IS SIGNAL, THIS IS A

1083
00:43:16,200 --> 00:43:18,040
TRUE REALITY OF THE PLACE TO

1084
00:43:18,040 --> 00:43:19,920
WHERE WE WOULD HOPE TO

1085
00:43:19,920 --> 00:43:20,600
GENERALIZE TRIAL RESULTS,

1086
00:43:20,600 --> 00:43:23,840
THEREFORE YOU MUST ADAPT OR

1087
00:43:23,840 --> 00:43:25,800
ACCOMMODATE TO IT.

1088
00:43:25,800 --> 00:43:29,040
TO ME IT'S A REALLY IMPORTANT

1089
00:43:29,040 --> 00:43:30,160
QUESTION WHEN YOU THINK IF

1090
00:43:30,160 --> 00:43:31,560
THERE'S A BARRIER DO YOU NEED TO

1091
00:43:31,560 --> 00:43:32,680
CHANGE THE ENVIRONMENT TO TAKE

1092
00:43:32,680 --> 00:43:34,360
AWAY THE BARRIER OR DO YOU NEED

1093
00:43:34,360 --> 00:43:39,040
TO CHANGE THE INTERVENTION TO

1094
00:43:39,040 --> 00:43:39,840
ACCOMMODATE THE BARRIER?

1095
00:43:39,840 --> 00:43:42,880
>> YEAH, SUCH A GOOD
QUESTION,

1096
00:43:42,880 --> 00:43:43,080
GREG.

1097
00:43:43,080 --> 00:43:48,800
I HAVE TO SAY THE EXAMPLE I GAVE

1098
00:43:48,800 --> 00:43:49,640
AROUND CO-PAYMENTS FOR

1099
00:43:49,640 --> 00:43:51,200
COLORECTAL CANCER SCREENING AND

1100
00:43:51,200 --> 00:43:56,120
A DECISION THE PROVIDER MIGHT

1101
00:43:56,120 --> 00:44:01,040
MAKE GIVEN BOTH WOULD HAVE NO

1102
00:44:01,040 --> 00:44:03,440
CO-PAYMENTS BUT THE FOLLOW-UP

1103
00:44:03,440 --> 00:44:06,600
COLONOSCOPY WOULD IF THE TEST

1104
00:44:06,600 --> 00:44:07,960
WAS ABNORMAL, WE'RE TRAINED TO

1105
00:44:07,960 --> 00:44:08,960
ADAPT, RIGHT?

1106
00:44:08,960 --> 00:44:10,760
OH, WE NEED TO CHANGE THE

1107
00:44:10,760 --> 00:44:13,000
INTERVENTION, NEED TO CHANGE HOW

1108
00:44:13,000 --> 00:44:14,440
IT'S BEING DELIVERED, AND THIS

1109
00:44:14,440 --> 00:44:17,040
WAS ACTUALLY AN ISSUE THAT WE'RE

1110
00:44:17,040 --> 00:44:18,800
LIKE WHAT CAN WE DO?

1111
00:44:18,800 --> 00:44:22,640
LIKE WE COULDN'T THINK OF HOW WE

1112
00:44:22,640 --> 00:44:24,280
WOULD ADAPT THE PROGRAM TO DEAL

1113
00:44:24,280 --> 00:44:25,480
WITH THIS BARRIER.

1114
00:44:25,480 --> 00:44:27,680
SO IT REALLY FELT, TO US, THAT

1115
00:44:27,680 --> 00:44:29,320
THERE WAS ONLY A POLICY

1116
00:44:29,320 --> 00:44:29,960
SOLUTION.

1117
00:44:29,960 --> 00:44:32,240
AND I THINK THAT'S WHY WE

1118
00:44:32,240 --> 00:44:35,360
PURSUED THAT APPROACH BECAUSE WE

1119
00:44:35,360 --> 00:44:36,320
COULDN'T IMAGINE, COULDN'T DREAM

1120
00:44:36,320 --> 00:44:38,720
UP A WAY WE COULD STILL

1121
00:44:38,720 --> 00:44:39,600
ENCOURAGE THESE PROVIDERS WHO

1122
00:44:39,600 --> 00:44:41,600
FELT LIKE THEY WERE FACING AN

1123
00:44:41,600 --> 00:44:43,360
ETHICAL DILEMMA, RIGHT?

1124
00:44:43,360 --> 00:44:45,280
LIKE IF I GIVE THIS TO MY

1125
00:44:45,280 --> 00:44:47,640
PATIENT THEY MAY FACE CO-PAYS

1126
00:44:47,640 --> 00:44:49,080
AND THEY ARE NOT GOING TO GET

1127
00:44:49,080 --> 00:44:51,040
THE COLONOSCOPY AND WHAT DO I

1128
00:44:51,040 --> 00:44:51,480
DO?

1129
00:44:51,480 --> 00:44:53,480
IT WAS BOTH ETHICAL AND

1130
00:44:53,480 --> 00:44:54,600
PRACTICAL CHALLENGE THEY WERE

1131
00:44:54,600 --> 00:44:55,360
ENCOUNTERING AND WE COULDN'T

1132
00:44:55,360 --> 00:44:59,200
DREAM OF A WAY TO FIX IT OTHER

1133
00:44:59,200 --> 00:44:59,600
THAN POLICY.

1134
00:44:59,600 --> 00:45:00,720
>> YEAH, IT'S AN
INTERESTING

1135
00:45:00,720 --> 00:45:02,560
QUESTION BECAUSE THE TRIAL

1136
00:45:02,560 --> 00:45:06,320
RESULTS ARE NOT FOR NOW, THEY

1137
00:45:06,320 --> 00:45:07,960
ARE FOR THE FUTURE, TO INFORM

1138
00:45:07,960 --> 00:45:09,360
WHAT PEOPLE CAN DO IN THE FUTURE

1139
00:45:09,360 --> 00:45:10,360
AND WE CAN'T KNOW WHAT THE

1140
00:45:10,360 --> 00:45:11,680
FUTURE WILL BE LIKE.

1141
00:45:11,680 --> 00:45:14,640
BUT OUR LAWS ARE EASIER TO

1142
00:45:14,640 --> 00:45:16,600
CHANGE THAN PEOPLE, YOU KNOW.

1143
00:45:16,600 --> 00:45:18,880
ONE OF MY RULES WOULD BE TO THE

1144
00:45:18,880 --> 00:45:20,040
EXTENT THE BARRIER INVOLVES

1145
00:45:20,040 --> 00:45:22,640
POLICIES AND LAWS THEY CAN

1146
00:45:22,640 --> 00:45:26,520
CHANGE TO THE EXTENT THE BARRIER

1147
00:45:26,520 --> 00:45:27,440
INVOLVES FUNDAMENTALS OF HUMAN

1148
00:45:27,440 --> 00:45:33,800
BEHAVIOR NOT GOING TO CHANGE.

1149
00:45:33,800 --> 00:45:34,760
>> NICE PERSPECTIVE.

1150
00:45:34,760 --> 00:45:37,840
>> I WANT TO SHIFT GEARS
A

1151
00:45:37,840 --> 00:45:40,080
LITTLE BIT, NATALIA WAS

1152
00:45:40,080 --> 00:45:43,520
MENTIONING THE UG3/UH3 PHASES

1153
00:45:43,520 --> 00:45:45,040
THAT THE COLLABORATORY USES, AND

1154
00:45:45,040 --> 00:45:47,360
WE KNOW THAT OTHER MECHANISMS

1155
00:45:47,360 --> 00:45:50,640
AND FUNDERS ARE USING SOME

1156
00:45:50,640 --> 00:45:51,720
SIMILAR APPROACHES OF HAVING,

1157
00:45:51,720 --> 00:45:56,000
YOU KNOW, A PLANNING PHASE AND

1158
00:45:56,000 --> 00:45:57,880
THEN THE ACTUAL IMPLEMENTATION

1159
00:45:57,880 --> 00:46:00,800
OF THE TRIAL PHASE, AND WHEN WE

1160
00:46:00,800 --> 00:46:03,000
THINK ABOUT EARLY LEARNING AND

1161
00:46:03,000 --> 00:46:05,960
OPPORTUNITIES TO KIND OF SQUEEZE

1162
00:46:05,960 --> 00:46:07,160
MORE INFORMATION OUT OF OUR

1163
00:46:07,160 --> 00:46:09,760
EXPERIENCES SO THAT WE CAN

1164
00:46:09,760 --> 00:46:12,960
ANTICIPATE WHAT MIGHT BE COMING,

1165
00:46:12,960 --> 00:46:16,000
DO YOU THREE THINK THERE WERE

1166
00:46:16,000 --> 00:46:18,600
ANY OPPORTUNITIES TO DO

1167
00:46:18,600 --> 00:46:21,040
ADDITIONAL WORK IN THE PLANNING

1168
00:46:21,040 --> 00:46:24,200
PHASE, THAT FIRST YEAR, AND WHAT

1169
00:46:24,200 --> 00:46:26,280
IF IT HAD BEEN TWO YEARS, WHAT'S

1170
00:46:26,280 --> 00:46:28,160
THE OPPORTUNITY FOR GETTING EVEN

1171
00:46:28,160 --> 00:46:29,880
MORE LEARNING IN THAT PHASE

1172
00:46:29,880 --> 00:46:37,160
BEFORE THE TRIAL IS IMPLEMENTED?

1173
00:46:37,160 --> 00:46:40,120
SO WHAT ARE YOUR THOUGHTS ABOUT

1174
00:46:40,120 --> 00:46:40,320
THAT?

1175
00:46:40,320 --> 00:46:41,320
>> THIS IS GLORIA.

1176
00:46:41,320 --> 00:46:42,320
I'LL START.

1177
00:46:42,320 --> 00:46:44,160
ONE OF THE APPROACHES WE TOOK

1178
00:46:44,160 --> 00:46:49,960
FOR OUR PILOT, AND WE WERE BUSY

1179
00:46:49,960 --> 00:46:52,440
DURING THE PILOT YEAR, BUT TO

1180
00:46:52,440 --> 00:46:55,000
REALLY PILOT TEST OUR

1181
00:46:55,000 --> 00:46:56,200
INTERVENTION, IN OUR MOST

1182
00:46:56,200 --> 00:46:57,640
DIVERSE CLINIC.

1183
00:46:57,640 --> 00:46:59,240
THIS REALLY HELPED US DEVELOP

1184
00:46:59,240 --> 00:47:02,680
MATERIALS IN ENGLISH AND SPANISH

1185
00:47:02,680 --> 00:47:03,960
AND DO SOME FORMATIVE WORK SO WE

1186
00:47:03,960 --> 00:47:06,040
WOULD HAVE A SET OF MATERIALS

1187
00:47:06,040 --> 00:47:10,320
THAT WERE -- AND APPROACHES

1188
00:47:10,320 --> 00:47:13,040
GENERALIZABLE TO THE OTHER

1189
00:47:13,040 --> 00:47:15,000
SITES, EFFECTIVE APPROACH.

1190
00:47:15,000 --> 00:47:17,120
WE DEVELOPED TOOLS, GOT

1191
00:47:17,120 --> 00:47:18,640
FEEDBACK, WORKED WITH OUR I.T.

1192
00:47:18,640 --> 00:47:19,600
SPECIALISTS FROM EACH OF OUR

1193
00:47:19,600 --> 00:47:20,720
HEALTH CENTERS TO DEVELOP THE

1194
00:47:20,720 --> 00:47:24,760
TOOLS IN A WAY THAT MADE SENSE

1195
00:47:24,760 --> 00:47:25,000
TO THEM.

1196
00:47:25,000 --> 00:47:27,280
WE VALIDATED WHETHER WE WERE

1197
00:47:27,280 --> 00:47:28,840
ACTUALLY CAPTURING PATIENTS WHO

1198
00:47:28,840 --> 00:47:32,320
WERE DUE BECAUSE WE KIND OF WENT

1199
00:47:32,320 --> 00:47:33,200
INTO THIS THINKING, OH, THE

1200
00:47:33,200 --> 00:47:35,600
CLINICS, YOU KNOW, ARE DOING A

1201
00:47:35,600 --> 00:47:37,560
LOT OF PROMOTION, WE'RE GOING TO

1202
00:47:37,560 --> 00:47:39,080
KIND OF BOOST THEIR EFFORTS.

1203
00:47:39,080 --> 00:47:41,080
WHAT WE REALIZE IS THEY WEREN'T

1204
00:47:41,080 --> 00:47:44,120
DOING A LOT OF FIT PROMOTION, IN

1205
00:47:44,120 --> 00:47:48,080
SOME CASES CLINICS WERE STILL

1206
00:47:48,080 --> 00:47:50,000
USING A THREE SAMPLE FOBT AND

1207
00:47:50,000 --> 00:47:51,760
WANTED TO SWITCH BEFORE THE

1208
00:47:51,760 --> 00:47:53,400
TRIAL STARTED, A LOT OF STUFF WE

1209
00:47:53,400 --> 00:47:54,960
DID IN THE SINGLE YEAR.

1210
00:47:54,960 --> 00:47:57,160
I WOULD SAY IF ANYTHING ANOTHER

1211
00:47:57,160 --> 00:47:58,240
SIX MONTHS PROBABLY WOULD HAVE

1212
00:47:58,240 --> 00:48:01,600
BEEN VALUABLE TO TEST OUT A FEW

1213
00:48:01,600 --> 00:48:04,680
THINGS, BUT WE DID A HECK OF A

1214
00:48:04,680 --> 00:48:12,680
LOT IN THAT SHORT AMOUNT OF

1215
00:48:12,680 --> 00:48:12,880
TIME.

1216
00:48:12,880 --> 00:48:15,000
>> THANKS, GLORIA.

1217
00:48:15,000 --> 00:48:17,080
CORITA AND NATALIA WHAT ARE YOUR

1218
00:48:17,080 --> 00:48:17,840
THOUGHTS FOR OPPORTUNITIES FOR

1219
00:48:17,840 --> 00:48:18,240
EARLY LEARNING.

1220
00:48:18,240 --> 00:48:19,920
>> I AGREE WITH GLORIA,
ANOTHER

1221
00:48:19,920 --> 00:48:22,200
SIX MONTHS WOULD HAVE BEEN NICE.

1222
00:48:22,200 --> 00:48:25,400
TWO YEARS FEELS A LITTLE LONG,

1223
00:48:25,400 --> 00:48:26,880
TO BE HONEST, BECAUSE OPTIMUM IS

1224
00:48:26,880 --> 00:48:27,840
THREE SITES IT WAS REALLY

1225
00:48:27,840 --> 00:48:29,720
IMPORTANT FOR ME TO PILOT AT ALL

1226
00:48:29,720 --> 00:48:31,560
THREE SITES.

1227
00:48:31,560 --> 00:48:35,920
THE MEDICAL CENTERS WERE VERY,

1228
00:48:35,920 --> 00:48:36,760
AGAIN, FOR HETEROGENEITY,

1229
00:48:36,760 --> 00:48:38,880
MEDICAL CENTERS WERE VERY

1230
00:48:38,880 --> 00:48:39,400
DIFFERENT.

1231
00:48:39,400 --> 00:48:41,840
WHAT WAS UNEXPECTED, WHAT WE

1232
00:48:41,840 --> 00:48:43,040
LEARNED, IS PEOPLE -- BECAUSE IT

1233
00:48:43,040 --> 00:48:45,440
WAS PILOTED AT ALL THE SITES,

1234
00:48:45,440 --> 00:48:50,280
SOME OF THE SITES EXPERIENCED

1235
00:48:50,280 --> 00:48:51,360
CERTAIN BEHAVIORS IN

1236
00:48:51,360 --> 00:48:53,120
PARTICIPANTS THAT THE OTHER

1237
00:48:53,120 --> 00:48:56,160
SITES DIDN'T.

1238
00:48:56,160 --> 00:49:03,600
FOR EXAMPLE, NORMALLY IN AN

1239
00:49:03,600 --> 00:49:06,560
IN-PERSON GROUP, MEDICAL GROUP,

1240
00:49:06,560 --> 00:49:08,000
PEOPLE FELT COMFORTABLE SMOKING

1241
00:49:08,000 --> 00:49:09,640
AND SO WE DECIDED WE WERE GOING

1242
00:49:09,640 --> 00:49:13,520
TO DO SOME RULES FOR

1243
00:49:13,520 --> 00:49:14,440
PARTICIPANTS THAT WOULD NOT HAVE

1244
00:49:14,440 --> 00:49:15,840
HAPPENED IF WE HADN'T DONE THE

1245
00:49:15,840 --> 00:49:16,640
PILOT AHEAD OF TIME.

1246
00:49:16,640 --> 00:49:18,360
THERE ARE OTHER THINGS WE

1247
00:49:18,360 --> 00:49:20,760
DISCUSSED THAT WE DECIDED IT WAS

1248
00:49:20,760 --> 00:49:24,160
ACCESSIBLE, WORKING WITH CHRONIC

1249
00:49:24,160 --> 00:49:26,240
PAIN POPULATION, IT WAS TOO HARD

1250
00:49:26,240 --> 00:49:28,960
FOR THEM TO STAY FOR THE

1251
00:49:28,960 --> 00:49:29,480
TWO-HOUR SESSIONS.

1252
00:49:29,480 --> 00:49:31,400
SO IT WAS INTERESTING.

1253
00:49:31,400 --> 00:49:33,760
I THINK AHEAD OF TIME I HAD

1254
00:49:33,760 --> 00:49:36,000
REALLY WANTED TO PILOT IT AT ALL

1255
00:49:36,000 --> 00:49:39,600
THREE SITES BUT I GOT

1256
00:49:39,600 --> 00:49:43,120
INFORMATION, THE WHOLE TEAM GOT

1257
00:49:43,120 --> 00:49:44,760
INFORMATION, ONE SITE WAS ABLE

1258
00:49:44,760 --> 00:49:46,200
TO SHARE WITH OTHER SITES THAT

1259
00:49:46,200 --> 00:49:50,440
ACTUALLY IMPACTED WHAT WE DID.

1260
00:49:50,440 --> 00:49:53,480
THERE'S SO MUCH TO DO IN THAT

1261
00:49:53,480 --> 00:49:55,560
FIRST YEAR, IT GETS COMPACTED

1262
00:49:55,560 --> 00:49:56,680
BECAUSE OF THE REQUIREMENTS,

1263
00:49:56,680 --> 00:49:57,680
WHEN THINGS ARE DUE, FOR

1264
00:49:57,680 --> 00:49:58,120
EXAMPLE.

1265
00:49:58,120 --> 00:49:59,520
BUT THIS IS WHERE MORE TIME

1266
00:49:59,520 --> 00:50:00,120
WOULD HAVE BEEN NICE.

1267
00:50:00,120 --> 00:50:01,600
BUT ON THE OTHER HAND IT WAS

1268
00:50:01,600 --> 00:50:04,000
ALSO NICE TO GET THAT YEAR OVER

1269
00:50:04,000 --> 00:50:04,320
WITH.

1270
00:50:04,320 --> 00:50:06,080
SO, YOU KNOW, AND MOVE FORWARD.

1271
00:50:06,080 --> 00:50:08,920
I DON'T MEAN IT THAT WAY BUT

1272
00:50:08,920 --> 00:50:10,800
JUST GET THAT PILOTING PART DONE

1273
00:50:10,800 --> 00:50:12,000
AND OVER WITH.

1274
00:50:12,000 --> 00:50:15,400
I WOULD SAY THE DECISION TO

1275
00:50:15,400 --> 00:50:20,320
PILOT IN ONE, ONE SITE, WAS

1276
00:50:20,320 --> 00:50:22,760
REALLY CRITICAL FOR US.

1277
00:50:22,760 --> 00:50:23,400
>> GREAT, THANKS.

1278
00:50:23,400 --> 00:50:25,480
>> YEAH, I WOULD SAY TWO
SITES

1279
00:50:25,480 --> 00:50:25,760
ABSOLUTELY.

1280
00:50:25,760 --> 00:50:28,440
I THINK ONE YEAR IS REALLY

1281
00:50:28,440 --> 00:50:30,360
CHALLENGING WHERE YOU'RE WORKING

1282
00:50:30,360 --> 00:50:31,960
IN THE SAFETY YET HOSPITAL

1283
00:50:31,960 --> 00:50:35,440
BECAUSE THEY CAN'T EVEN GET A

1284
00:50:35,440 --> 00:50:37,720
CONTRACT THROUGH, SUBCONTRACT

1285
00:50:37,720 --> 00:50:38,360
THROUGH.

1286
00:50:38,360 --> 00:50:40,440
WE PILOTED A NYU, WHICH WAS

1287
00:50:40,440 --> 00:50:41,440
EASY, YOU KNOW, BECAUSE WE

1288
00:50:41,440 --> 00:50:43,400
DIDN'T HAVE THE MONEY TO PAY

1289
00:50:43,400 --> 00:50:44,400
INCENTIVES OR WHATEVER, WE

1290
00:50:44,400 --> 00:50:46,000
COULD, YOU KNOW, BORROW AND PAY

1291
00:50:46,000 --> 00:50:48,840
BACK LATER.

1292
00:50:48,840 --> 00:50:50,280
BUT OUR SECOND SITE WAS

1293
00:50:50,280 --> 00:50:53,040
UNIVERSITY HOSPITAL IN NEWARK,

1294
00:50:53,040 --> 00:50:54,560
WHERE THERE IS JUST -- I DON'T

1295
00:50:54,560 --> 00:50:56,280
THINK WE PAID THEM A DOLLAR TO

1296
00:50:56,280 --> 00:50:58,840
THIS DAY, IT WAS SO CHALLENGING

1297
00:50:58,840 --> 00:51:01,880
TO GET THINGS THROUGH THEIR

1298
00:51:01,880 --> 00:51:03,200
CONTRACTS OFFICE, THEY HAVE NO

1299
00:51:03,200 --> 00:51:07,480
SUPPORT FOR RESEARCH.

1300
00:51:07,480 --> 00:51:09,480
SO I THINK, YEAH, OUTSIDE OF TWO

1301
00:51:09,480 --> 00:51:11,440
YEARS WOULD HAVE BEEN EASIER.

1302
00:51:11,440 --> 00:51:17,120
MY VOTE IS FOR TWO PLUS FOUR BUT

1303
00:51:17,120 --> 00:51:19,720
FOR THE UG3/UH3, BUT ESPECIALLY

1304
00:51:19,720 --> 00:51:21,680
WHEN WORKING IN SAFETY NET

1305
00:51:21,680 --> 00:51:22,680
ORGANIZATIONS AND HEALTH SYSTEMS

1306
00:51:22,680 --> 00:51:24,120
IT'S VERY CHALLENGING TO GET

1307
00:51:24,120 --> 00:51:28,640
THINGS DONE IN REAL TIME.

1308
00:51:28,640 --> 00:51:31,480
>> SUCH A GREAT POINT,
CORITA.

1309
00:51:31,480 --> 00:51:34,080
AND KNOWING I THINK THERE'S A

1310
00:51:34,080 --> 00:51:36,360
GENERAL PUSH TO DO RESEARCH IN A

1311
00:51:36,360 --> 00:51:40,920
BROADER RANGE OF SETTINGS,

1312
00:51:40,920 --> 00:51:41,480
INCLUDING UNDERRESOURCED

1313
00:51:41,480 --> 00:51:43,320
SETTINGS, SOUND LIKE IT WOULD BE

1314
00:51:43,320 --> 00:51:44,760
USEFUL TO CONSIDER THE LONGER

1315
00:51:44,760 --> 00:51:48,400
TIME IT WOULD TAKE TO EVEN DO

1316
00:51:48,400 --> 00:51:50,960
THAT PILOT LEVEL LEARNING TO GET

1317
00:51:50,960 --> 00:51:55,120
THOSE EARLY SIGNALS OF SUCCESS,

1318
00:51:55,120 --> 00:51:55,360
YEAH. 

1319
00:51:55,360 --> 00:51:59,040
YOU KNOW, THERE WAS ANOTHER

1320
00:51:59,040 --> 00:52:01,120
THEME THAT I HEARD, THE

1321
00:52:01,120 --> 00:52:02,560
IMPORTANCE OF A

1322
00:52:02,560 --> 00:52:04,080
MULTI-STAKEHOLDER PANEL IN

1323
00:52:04,080 --> 00:52:05,160
HELPING TO FIGURE OUT WHAT

1324
00:52:05,160 --> 00:52:09,000
THINGS NEEDED TO BE LEARNED AND

1325
00:52:09,000 --> 00:52:11,320
REACT TO LEARNINGS THERE.

1326
00:52:11,320 --> 00:52:15,120
I WONDER IF YOU ALL HAVE ANY

1327
00:52:15,120 --> 00:52:18,600
TIPS FOR HOW BEST TO USE SUCH A

1328
00:52:18,600 --> 00:52:21,360
PANEL TO IDENTIFY THOSE EARLY

1329
00:52:21,360 --> 00:52:30,560
SIGNALS AND DIGEST THEM

1330
00:52:30,560 --> 00:52:30,840
INTERNALLY.

1331
00:52:30,840 --> 00:52:34,040
>> I GUESS I CAN START.

1332
00:52:34,040 --> 00:52:38,120
SO, OUR PANEL MEETS MONTHLY.

1333
00:52:38,120 --> 00:52:40,000
AND IT TAKES TIME, COMMUNITY

1334
00:52:40,000 --> 00:52:42,000
ADVISORY BOARD MEETS MONTHLY.

1335
00:52:42,000 --> 00:52:45,800
AND SO ONE IS I KNEW TO GET A

1336
00:52:45,800 --> 00:52:49,360
REALTIME FEEDBACK THAT WOULD BE

1337
00:52:49,360 --> 00:52:51,680
USEFUL FOR THE BOARD, WE WOULD

1338
00:52:51,680 --> 00:52:53,560
NEED TO MEET MORE FREQUENTLY.

1339
00:52:53,560 --> 00:52:55,000
NOT ALL COMMUNITY ADVISORY

1340
00:52:55,000 --> 00:52:57,720
BOARDS MIGHT MEET THAT

1341
00:52:57,720 --> 00:52:58,000
FREQUENTLY.

1342
00:52:58,000 --> 00:52:59,680
FOR US IT'S BEEN VERY, VERY

1343
00:52:59,680 --> 00:53:00,000
LEEPFUL.

1344
00:53:00,000 --> 00:53:07,800
THIS  -- HELPFUL.

1345
00:53:07,800 --> 00:53:13,840
IT DOESN'T JUST HAPPEN AT

1346
00:53:13,840 --> 00:53:14,880
SPECIFIC TIMES.

1347
00:53:14,880 --> 00:53:16,520
AND SO WE COULD REAL TIME BRING

1348
00:53:16,520 --> 00:53:20,480
UP ISSUES TO OUR BOARD AND THEN

1349
00:53:20,480 --> 00:53:21,240
GET FEEDBACK.

1350
00:53:21,240 --> 00:53:23,200
BECAUSE WE ALREADY HAD A SYSTEM

1351
00:53:23,200 --> 00:53:24,280
IN PLACE WITH COMMUNICATION, I

1352
00:53:24,280 --> 00:53:27,000
MENTIONED BEFORE WITH THE TEAM,

1353
00:53:27,000 --> 00:53:29,200
WE COULD RAPIDLY IMPLEMENT IT.

1354
00:53:29,200 --> 00:53:32,200
SOME HAS TO DEAL WITH ADDING

1355
00:53:32,200 --> 00:53:33,400
CONFIDENTIALITY LANGUAGE, FOR

1356
00:53:33,400 --> 00:53:37,560
EXAMPLE, TO THE TELEPHONE

1357
00:53:37,560 --> 00:53:39,480
SCRIPTS THAT WE USE.

1358
00:53:39,480 --> 00:53:40,800
REALLY REAL TIME, THAT WAS ONE

1359
00:53:40,800 --> 00:53:47,800
OF THE WAYS WE HAVE DONE IT, BY,

1360
00:53:47,800 --> 00:53:50,320
ONE, FREQUENCY OF MEETINGS, TWO

1361
00:53:50,320 --> 00:53:54,680
HAVING AGENDAS WITH FLEXIBILITY

1362
00:53:54,680 --> 00:54:01,600
TO ADD AGENDAS, AND ABILITY TO

1363
00:54:01,600 --> 00:54:02,360
IMPLEMENT EFFECTIVELY WHAT'S

1364
00:54:02,360 --> 00:54:02,640
RECOMMENDED.

1365
00:54:02,640 --> 00:54:07,040
I'D BE INTERESTED IN THE PDSA

1366
00:54:07,040 --> 00:54:08,440
CYCLE YOU MENTIONED, GLORIA, HOW

1367
00:54:08,440 --> 00:54:11,560
LONG IT TOOK TO DO THOSE CYCLES

1368
00:54:11,560 --> 00:54:13,520
RELATED TO HOW TO DECIDE WHAT TO

1369
00:54:13,520 --> 00:54:17,800
DO AND THE IN THE CYCLES.

1370
00:54:17,800 --> 00:54:19,000
>> YEAH, SO WE, YOU KNOW,
WENT

1371
00:54:19,000 --> 00:54:22,200
TO EACH OF OUR HEALTH CENTERS,

1372
00:54:22,200 --> 00:54:26,880
SO 26 CLINICS, I THINK ABOUT

1373
00:54:26,880 --> 00:54:28,800
EIGHT FEDERALLY QUALIFIED HEALTH

1374
00:54:28,800 --> 00:54:31,440
CENTERS, WE MET WITH LEADERSHIP

1375
00:54:31,440 --> 00:54:34,160
TEAMS, CARVED OUT A TWO-HOUR

1376
00:54:34,160 --> 00:54:36,600
MEETING TO REFRESH KNOWLEDGE OF

1377
00:54:36,600 --> 00:54:38,000
PDSAs, INTRODUCE FORMS AND

1378
00:54:38,000 --> 00:54:38,360
REQUIREMENTS.

1379
00:54:38,360 --> 00:54:42,480
THEN WE ARRIVE AT THAT MEETING,

1380
00:54:42,480 --> 00:54:44,120
ALLOWED TIME FOR BRAINSTORMING

1381
00:54:44,120 --> 00:54:45,240
BECAUSE THEY WERE MEETING AND

1382
00:54:45,240 --> 00:54:46,760
MIGHT THINK OF IDEAS RIGHT AWAY.

1383
00:54:46,760 --> 00:54:50,840
THEN I THINK IT WAS ABOUT TWO

1384
00:54:50,840 --> 00:54:53,800
MONTHS LATER THAT WE ASKED THEM

1385
00:54:53,800 --> 00:54:55,880
TO PRESENT THEIR FINDINGS AT A

1386
00:54:55,880 --> 00:54:56,960
BOARD MEETING, TWO OR THREE

1387
00:54:56,960 --> 00:55:00,000
MONTHS LATER THAT WE HEARD ABOUT

1388
00:55:00,000 --> 00:55:01,880
THEIR FINDINGS.

1389
00:55:01,880 --> 00:55:04,160
IT WAS SUCH A GREAT PROCESS FOR

1390
00:55:04,160 --> 00:55:05,720
OUR PROJECT FOR A COUPLE

1391
00:55:05,720 --> 00:55:06,320
REASONS.

1392
00:55:06,320 --> 00:55:08,760
ONE IS THAT WE, AGAIN, FOUND ALL

1393
00:55:08,760 --> 00:55:10,000
THESE REALLY INTERESTING

1394
00:55:10,000 --> 00:55:13,160
CHALLENGES THAT WE WOULDN'T HAVE

1395
00:55:13,160 --> 00:55:14,480
OTHERWISE THOUGHT ABOUT OR

1396
00:55:14,480 --> 00:55:16,640
LEARNED ABOUT WAY TOO LATE,

1397
00:55:16,640 --> 00:55:17,320
BECAUSE WE HAD ACTIVITIES

1398
00:55:17,320 --> 00:55:18,760
PLANNED AT THE END BUT THEY

1399
00:55:18,760 --> 00:55:19,640
WOULDN'T HAVE AN ACTIONABLE.

1400
00:55:19,640 --> 00:55:21,040
SO THAT WAS REALLY HELPFUL.

1401
00:55:21,040 --> 00:55:24,600
BUT THE OTHER THING THAT WE

1402
00:55:24,600 --> 00:55:26,280
ENCOUNTERED IS THAT I THINK

1403
00:55:26,280 --> 00:55:29,240
PERSPECTIVE OF OUR CLINICS WAS

1404
00:55:29,240 --> 00:55:31,320
LIKE, OKAY, YOU'RE WORKING WITH

1405
00:55:31,320 --> 00:55:33,080
THAT CLINIC, SO THAT ONE IS

1406
00:55:33,080 --> 00:55:37,440
YOURS TO WORK WITH, AND SO WE'LL

1407
00:55:37,440 --> 00:55:40,920
DO STUFF IN OUR USUAL CARE

1408
00:55:40,920 --> 00:55:42,640
CLINICS, SO REALLY INITIALLY

1409
00:55:42,640 --> 00:55:45,880
HANDS OFF WITH THE CLINICS THAT

1410
00:55:45,880 --> 00:55:46,600
WERE INTERVENTION CLINICS, WHICH

1411
00:55:46,600 --> 00:55:49,360
IS NOT HOW WE WANTED IT TO BE.

1412
00:55:49,360 --> 00:55:51,240
LIKE WE NEEDED TO ENGAGE THEM,

1413
00:55:51,240 --> 00:55:52,840
NEEDED TO WORK WITH THEIR TEAMS

1414
00:55:52,840 --> 00:55:56,120
AND HAVE THEM, YOU KNOW,

1415
00:55:56,120 --> 00:55:56,880
CHAMPIONING THE INTERVENTION.

1416
00:55:56,880 --> 00:55:59,440
SO THE OTHER THING THAT REALLY

1417
00:55:59,440 --> 00:56:00,640
CHANGED WAS THAT WILLINGNESS TO

1418
00:56:00,640 --> 00:56:02,560
DIG IN AND GET YOUR HANDS DIRTY

1419
00:56:02,560 --> 00:56:03,680
AND THINK ABOUT THE CHALLENGES

1420
00:56:03,680 --> 00:56:06,440
AND THINK ABOUT HOW YOU MIGHT

1421
00:56:06,440 --> 00:56:06,920
SOLVE THOSE CHALLENGES.

1422
00:56:06,920 --> 00:56:08,840
AND SO IT WAS REALLY HELPFUL

1423
00:56:08,840 --> 00:56:11,240
FROM THAT PERSPECTIVE AS WELL,

1424
00:56:11,240 --> 00:56:12,440
JUST REALLY HELPING THEM

1425
00:56:12,440 --> 00:56:13,360
UNDERSTAND THAT THAT'S AN OKAY

1426
00:56:13,360 --> 00:56:15,280
THING TO DO BECAUSE THIS IS A

1427
00:56:15,280 --> 00:56:16,520
PRAGMATIC STUDY AND WE'RE ASKING

1428
00:56:16,520 --> 00:56:18,160
THEM TO ACTUALLY DO IT, NOT US

1429
00:56:18,160 --> 00:56:22,880
TO COME IN AND DO THE STUDY WITH

1430
00:56:22,880 --> 00:56:28,640
THEIR PATIENTS.

1431
00:56:28,640 --> 00:56:30,080
>> THANKS, GLORIA.

1432
00:56:30,080 --> 00:56:30,720
OKAY.

1433
00:56:30,720 --> 00:56:32,920
WELL, THIS HAS BEEN REALLY

1434
00:56:32,920 --> 00:56:33,240
INTERESTING.

1435
00:56:33,240 --> 00:56:36,720
AND I WANT THE THREE OF YOU TO

1436
00:56:36,720 --> 00:56:38,320
HANG IN THROUGH THE NEXT FOUR

1437
00:56:38,320 --> 00:56:41,640
WHEN WE HAVE BROADER DISCUSSION,

1438
00:56:41,640 --> 00:56:43,640
PLEASE CAN'T TO SHARE YOUR

1439
00:56:43,640 --> 00:56:43,960
EXPERIENCES.

1440
00:56:43,960 --> 00:56:47,080
WE'LL MOVE NOW TO CONSIDER THE

1441
00:56:47,080 --> 00:56:49,400
DIFFERENT THINGS THAT DECISION

1442
00:56:49,400 --> 00:56:52,400
MAKERS MIGHT LOOK AT AS THEY ARE

1443
00:56:52,400 --> 00:56:53,880
MONITORING AND MAKING DECISIONS

1444
00:56:53,880 --> 00:56:56,440
ABOUT WHAT TO DO WITH THE STUDY

1445
00:56:56,440 --> 00:56:57,640
BASED ON EARLY SIGNALS THEY ARE

1446
00:56:57,640 --> 00:56:59,720
GETTING AND WE'LL HAVE FOUR

1447
00:56:59,720 --> 00:57:01,560
PERSPECTIVES AND WE'LL START

1448
00:57:01,560 --> 00:57:06,080
WITH DR. KEVIN CHAN, WHO IS AT

1449
00:57:06,080 --> 00:57:09,240
NIDDK, TO KICK US OFF.

1450
00:57:09,240 --> 00:57:10,520
KEVIN, TAKE IT AWAY.

1451
00:57:10,520 --> 00:57:13,520
>> THANK YOU, KEVIN, I'M
FROM

1452
00:57:13,520 --> 00:57:15,680
NIDDKA SPONSOR OF TRIALS, WORK

1453
00:57:15,680 --> 00:57:19,960
WITH P.I.s AND DSMBs, AND

1454
00:57:19,960 --> 00:57:22,920
HAVE SLIDES TO TALK HOW WE

1455
00:57:22,920 --> 00:57:27,520
PROCESS INFORMATION ABOUT

1456
00:57:27,520 --> 00:57:28,600
TRIALS.

1457
00:57:28,600 --> 00:57:30,880
NEXT SLIDE.

1458
00:57:30,880 --> 00:57:32,840
EMBEDDED CLINICAL TRIAL,

1459
00:57:32,840 --> 00:57:33,880
EFFECTIVENESS, TESTED EMBEDDED

1460
00:57:33,880 --> 00:57:36,160
IN USUAL CLINICAL CARE.

1461
00:57:36,160 --> 00:57:44,920
I WANT TO START, I THINK OF

1462
00:57:44,920 --> 00:57:47,720
THESE OF QUALITY IMPROVEMENT

1463
00:57:47,720 --> 00:57:49,080
PROJECTS, INHERENTLY CHALLENGING

1464
00:57:49,080 --> 00:57:52,960
WHEN YOU START CHANGING HOW A

1465
00:57:52,960 --> 00:57:55,320
HEALTH ECOSYSTEM OPERATES, OR

1466
00:57:55,320 --> 00:57:57,400
YOU START CHANGING PEOPLE'S JOB

1467
00:57:57,400 --> 00:57:59,200
DESCRIPTIONS, IT WAS MENTIONED

1468
00:57:59,200 --> 00:58:00,680
IT'S EASIER TO CHANGE LAWS THAT

1469
00:58:00,680 --> 00:58:02,520
BE PEOPLE, IT'S A COMPLEX

1470
00:58:02,520 --> 00:58:05,080
PROCESS TO GET THIS DONE IN

1471
00:58:05,080 --> 00:58:05,960
HEALTH SYSTEMS.

1472
00:58:05,960 --> 00:58:11,280
TO DO THIS WE DO THESE LARGE

1473
00:58:11,280 --> 00:58:14,560
QUALITY IMPROVEMENT PROJECTS,

1474
00:58:14,560 --> 00:58:17,400
THE WHOLE RESOURCES THAT HELP

1475
00:58:17,400 --> 00:58:21,920
YOU BE SUCCESSFUL, SUCH AS

1476
00:58:21,920 --> 00:58:26,520
TRAINING, OPERATIONS, REALTIME

1477
00:58:26,520 --> 00:58:28,480
DATA REPORTING, MONITORING, ROOT

1478
00:58:28,480 --> 00:58:29,280
CAUSE ANALYSIS.

1479
00:58:29,280 --> 00:58:30,600
NOT ALL TRIALS MAY HAVE ACCESS

1480
00:58:30,600 --> 00:58:34,800
TO ALL THESE RESOURCES TO

1481
00:58:34,800 --> 00:58:35,800
IMPLEMENT COMPLEX AND

1482
00:58:35,800 --> 00:58:36,600
HETEROGENEOUS INTERVENTIONS WE

1483
00:58:36,600 --> 00:58:37,240
TALKED ABOUT.

1484
00:58:37,240 --> 00:58:38,960
AND IT GETS MORE CHALLENGING

1485
00:58:38,960 --> 00:58:40,960
WHEN THE GOALS OF THE RESEARCH

1486
00:58:40,960 --> 00:58:45,120
DON'T ALIGN WITH THE HEALTH CARE

1487
00:58:45,120 --> 00:58:45,880
SYSTEM AND YOU'RE WORKING

1488
00:58:45,880 --> 00:58:47,880
AGAINST WHERE THE HEALTH SYSTEM

1489
00:58:47,880 --> 00:58:49,520
IS GOING.

1490
00:58:49,520 --> 00:58:50,360
NEXT SLIDE.

1491
00:58:50,360 --> 00:58:54,640
SO, I WAS ASKED TO TALK ABOUT

1492
00:58:54,640 --> 00:59:00,200
HOW TO MAKE GO AND NO GO

1493
00:59:00,200 --> 00:59:01,000
DECISIONS ON TRIALS.

1494
00:59:01,000 --> 00:59:02,640
I BELIEVE IN SECOND CHANCES, I

1495
00:59:02,640 --> 00:59:05,800
WANT YOU TO KEEP THAT IN MIND.

1496
00:59:05,800 --> 00:59:09,000
BUT IN A TRIAL INDICATIONS FOR

1497
00:59:09,000 --> 00:59:10,760
STOPPING THE TRIAL EARLY,

1498
00:59:10,760 --> 00:59:13,400
BUCKETED THEM INTO THREE

1499
00:59:13,400 --> 00:59:13,680
CATEGORIES.

1500
00:59:13,680 --> 00:59:17,000
ONE IS FUTILITY, A COUPLE WAYS

1501
00:59:17,000 --> 00:59:20,600
TO LOOK AT FUTILITY.

1502
00:59:20,600 --> 00:59:22,280
ANOTHER CATEGORY IS

1503
00:59:22,280 --> 00:59:24,200
NON-RANDOMIZED BIAS, MAYBE ITS

1504
00:59:24,200 --> 00:59:25,880
OWN CATEGORY.

1505
00:59:25,880 --> 00:59:30,040
SAFETY OR HARM, OR OVERWHELMING

1506
00:59:30,040 --> 00:59:30,680
EFFECTIVENESS OR NEW STUDIES

1507
00:59:30,680 --> 00:59:36,040
HAVE COME OUT THAT MAY CHANGE

1508
00:59:36,040 --> 00:59:36,600
CARE.

1509
00:59:36,600 --> 00:59:41,320
BUT GO AND NO GO, IT'S NOT ONE

1510
00:59:41,320 --> 00:59:42,000
SIGNAL.

1511
00:59:42,000 --> 00:59:44,240
IT'S A TOTALITY OF DATA.

1512
00:59:44,240 --> 00:59:49,200
I'LL TALK MORE AS WE GO ALONG.

1513
00:59:49,200 --> 00:59:49,880
NEXT SLIDE.

1514
00:59:49,880 --> 00:59:54,360
SO, IF YOU WANT TO THINK ABOUT

1515
00:59:54,360 --> 00:59:57,960
CHANGING OR STOPPING A TRIAL

1516
00:59:57,960 --> 00:59:59,680
EARLY, HAVING DATA AND GOOD DATA

1517
00:59:59,680 --> 01:00:04,760
EARLY IS I THINK ONE OF THE

1518
01:00:04,760 --> 01:00:06,640
FIRST FOUNDATIONS.

1519
01:00:06,640 --> 01:00:09,600
THIS IS FROM A PAPER BY

1520
01:00:09,600 --> 01:00:12,240
ELLENBERG, I'M NOT GOING TO GO

1521
01:00:12,240 --> 01:00:13,160
OVER IT IN DETAIL.

1522
01:00:13,160 --> 01:00:16,840
YOU CAN LOOK AT THE ARTICLE.

1523
01:00:16,840 --> 01:00:21,560
IT OUTLINES HOW TO MONITOR

1524
01:00:21,560 --> 01:00:23,880
PRAGMATIC CLINICAL TRIAL.

1525
01:00:23,880 --> 01:00:28,680
IN A PRAGMATIC TRIAL, A COUPLE

1526
01:00:28,680 --> 01:00:31,920
THINGS, DATA QUALITY, USING REAL

1527
01:00:31,920 --> 01:00:33,080
WORLD DATA FROM EHRs, NOT

1528
01:00:33,080 --> 01:00:36,880
PERFECTLY ASKER  -- ASCERTAINED.

1529
01:00:36,880 --> 01:00:39,400
WE CAN BUCKET INTO THREE

1530
01:00:39,400 --> 01:00:42,360
CATEGORIES OF HOW WOULD WE LOOK

1531
01:00:42,360 --> 01:00:45,960
AT THESE AND FOCUS ON LOOK AT

1532
01:00:45,960 --> 01:00:51,880
POWER, SEPARATION OR FIDELITY OF

1533
01:00:51,880 --> 01:00:53,440
THE INTERVENTION, NONRANDOM BIAS

1534
01:00:53,440 --> 01:00:54,640
IN AN UNBLINDED STUDY, I'LL TALK

1535
01:00:54,640 --> 01:00:56,480
MORE ABOUT THAT LATER.

1536
01:00:56,480 --> 01:01:01,840
THE LAST BUCKET IS SAFETY, IS

1537
01:01:01,840 --> 01:01:03,720
THIS CAUSING HARM TO PATIENTS.

1538
01:01:03,720 --> 01:01:04,120
NEXT SLIDES.

1539
01:01:04,120 --> 01:01:06,240
I WANT TO TALK ABOUT TWO THEMES

1540
01:01:06,240 --> 01:01:13,680
THAT SEEM TO SHOW UP MORE IN

1541
01:01:13,680 --> 01:01:16,200
PRAGMATIC TRIALS THAN TYPICAL

1542
01:01:16,200 --> 01:01:19,920
WELL-CONTROLLED TRIALS, FIDELITY

1543
01:01:19,920 --> 01:01:22,000
AND ADHERENCE.

1544
01:01:22,000 --> 01:01:23,240
WE'VE HAD LESS TIGHTLY

1545
01:01:23,240 --> 01:01:27,160
CONTROLLED BY RESEARCH TEAM THAT

1546
01:01:27,160 --> 01:01:27,920
PRAGMATIC TRIAL AND

1547
01:01:27,920 --> 01:01:31,320
INTERVENTION, AND WILL THE STUDY

1548
01:01:31,320 --> 01:01:31,960
ACHIEVE ADEQUATE SEPARATION,

1549
01:01:31,960 --> 01:01:33,840
SOMETHING THAT IS A BIGGER

1550
01:01:33,840 --> 01:01:36,440
CONCERN BECAUSE WE HAVE LESS

1551
01:01:36,440 --> 01:01:38,320
CONTROL OF THE INTERVENTION WHEN

1552
01:01:38,320 --> 01:01:40,720
THE INTERVENTION IS EMBEDDED ON

1553
01:01:40,720 --> 01:01:43,160
TOP OF TYPICAL CLINICAL CARE.

1554
01:01:43,160 --> 01:01:45,960
SO, ONE THING IS THE

1555
01:01:45,960 --> 01:01:47,080
REENGINEERING, WE'VE HEARD ABOUT

1556
01:01:47,080 --> 01:01:48,280
THE INTERVENTION AND MAKING

1557
01:01:48,280 --> 01:01:51,440
CHANGES AS WE GO ALONG.

1558
01:01:51,440 --> 01:01:53,280
THE OTHER DESIGN CONSIDERATION,

1559
01:01:53,280 --> 01:01:55,000
NOW I'VE BEEN HEARING FROM

1560
01:01:55,000 --> 01:01:56,200
LECTURES YOU SHOULD TRY TO

1561
01:01:56,200 --> 01:01:57,640
OVERPOWER YOUR TRIAL.

1562
01:01:57,640 --> 01:02:01,560
SO WE OVERPOWER TO ACCOUNT FOR

1563
01:02:01,560 --> 01:02:04,480
DROPOUT, WE SHOULD ALSO CONSIDER

1564
01:02:04,480 --> 01:02:06,320
A FACTOR TO OVERPOWER FOR LOWER

1565
01:02:06,320 --> 01:02:08,680
ADHERENCE OF UPTAKE OF THE

1566
01:02:08,680 --> 01:02:09,880
INTERVENTION, ANOTHER WAY TO

1567
01:02:09,880 --> 01:02:12,920
PROTECT AGAINST THIS.

1568
01:02:12,920 --> 01:02:16,440
NEXT SLIDE.

1569
01:02:16,440 --> 01:02:19,600
SO, THE OTHER ISSUE IN PRAGMATIC

1570
01:02:19,600 --> 01:02:23,320
CLINICAL TRIALS IS TRIALS ARE

1571
01:02:23,320 --> 01:02:24,760
NOT BLINDED.

1572
01:02:24,760 --> 01:02:26,200
SO, THEY ARE RANDOMIZED, WE DID

1573
01:02:26,200 --> 01:02:30,040
A LOT OF OBSERVATIONAL STUDIES,

1574
01:02:30,040 --> 01:02:31,200
SENT MANUSCRIPTS, THEY COME BACK

1575
01:02:31,200 --> 01:02:34,720
AND SAY IT'S NOT RANDOMIZED SO

1576
01:02:34,720 --> 01:02:36,600
WE DON'T KNOW THE UNMEASURED

1577
01:02:36,600 --> 01:02:37,680
FACTORS OF DIFFERENCES.

1578
01:02:37,680 --> 01:02:40,200
ONE THING OVERLOOKED IS POWER OF

1579
01:02:40,200 --> 01:02:41,160
BLINDED STUDY, TO PROTECT THE

1580
01:02:41,160 --> 01:02:46,520
TRIAL TO PROTECT IT FROM

1581
01:02:46,520 --> 01:02:50,600
NONRANDOM BIAS, ONCE THE TRIAL

1582
01:02:50,600 --> 01:02:50,840
STARTS.

1583
01:02:50,840 --> 01:02:52,880
PRESERVING INTERNAL VALIDITY OF

1584
01:02:52,880 --> 01:02:57,920
THE STUDY IN TRADITIONAL TRIALS.

1585
01:02:57,920 --> 01:03:02,600
AND THE CHALLENGE OF PRAGMATIC

1586
01:03:02,600 --> 01:03:04,000
TRIALS, IT'S OFTEN DIFFICULT OR

1587
01:03:04,000 --> 01:03:06,120
NOT FEASIBLE TO BLIND THE

1588
01:03:06,120 --> 01:03:09,120
INTERVENTION TO THE HEALTH CARE

1589
01:03:09,120 --> 01:03:10,680
PROVIDERS, OR WHO HAS DELIVERED

1590
01:03:10,680 --> 01:03:13,160
THE INTERVENTION, AND TO BLIND

1591
01:03:13,160 --> 01:03:15,800
THIS TO THE PARTICIPANTS.

1592
01:03:15,800 --> 01:03:20,120
AND THE CRUX OF THE TRIAL

1593
01:03:20,120 --> 01:03:22,560
ASSUMES THERE'S EQUI POISE

1594
01:03:22,560 --> 01:03:24,120
BETWEEN THE TWO TREATMENTS.

1595
01:03:24,120 --> 01:03:26,960
IF THERE'S NO EQUIPOISE THEN IT

1596
01:03:26,960 --> 01:03:27,920
MAKES IT MORE DIFFICULT TO

1597
01:03:27,920 --> 01:03:33,840
JUSTIFY A TRIAL.

1598
01:03:33,840 --> 01:03:34,400
NEXT SLIDE.

1599
01:03:34,400 --> 01:03:36,000
SO THIS IS A DIAGRAM.

1600
01:03:36,000 --> 01:03:37,120
AND WHEN I THOUGHT ABOUT THINGS

1601
01:03:37,120 --> 01:03:42,360
AND LOOKED AT THE LITERATURE,

1602
01:03:42,360 --> 01:03:45,680
ALL THE THINGS THAT COULD GO

1603
01:03:45,680 --> 01:03:47,520
WRONG AND CAUSE NONRANDOM BIAS

1604
01:03:47,520 --> 01:03:48,480
WHEN YOU'RE NOT BLINDED, COULD

1605
01:03:48,480 --> 01:03:51,920
START AT THE SCREENING PHASE

1606
01:03:51,920 --> 01:03:52,720
WHERE THERE'S DIFFERENT

1607
01:03:52,720 --> 01:03:54,080
APPLICATIONS, WHO YOU INCLUDE

1608
01:03:54,080 --> 01:03:56,120
AND EXCLUDE IF YOU KNOW WHAT THE

1609
01:03:56,120 --> 01:03:57,960
TREATMENT IS, THIS WOULD BE A

1610
01:03:57,960 --> 01:04:00,760
DIFFERENCE IN HOW PEOPLE ARE

1611
01:04:00,760 --> 01:04:01,040
CONSENTED.

1612
01:04:01,040 --> 01:04:02,640
AND ALSO PATIENTS HAVE

1613
01:04:02,640 --> 01:04:06,480
PREFERENCES, MAY CLUES TO HE

1614
01:04:06,480 --> 01:04:08,200
BE - MAY CHOOSE TO ENROLL IN ONE

1615
01:04:08,200 --> 01:04:10,520
GROUP AND NOT THE OTHER IF THEY

1616
01:04:10,520 --> 01:04:15,240
KNOW WHAT THEY ARE BEING

1617
01:04:15,240 --> 01:04:17,400
RANDOMIZED TO, RANDOMIZATION

1618
01:04:17,400 --> 01:04:18,720
OCCURS BEFORE ENTHUSIASM.

1619
01:04:18,720 --> 01:04:20,240
ENTHUSIASM, CROSSOVER FOR

1620
01:04:20,240 --> 01:04:21,680
PATIENTS WHO DON'T GET PREFERRED

1621
01:04:21,680 --> 01:04:29,440
CHOICES, THEY KNOW IT'S NOT

1622
01:04:29,440 --> 01:04:30,960
BLINDED, AND DIFFERENTIAL

1623
01:04:30,960 --> 01:04:32,320
REPORTING ESPECIALLY IF THERE'S

1624
01:04:32,320 --> 01:04:33,600
A HEALTH CARE PROVIDER

1625
01:04:33,600 --> 01:04:34,640
ASCERTAINING OUTCOMES.

1626
01:04:34,640 --> 01:04:40,000
THERE'S WAYS TO DEAL WITH THESE

1627
01:04:40,000 --> 01:04:42,480
ISSUES THAT IS NOT -- DOES NOT

1628
01:04:42,480 --> 01:04:44,240
USE BLINDING BUT THAT'S I THINK

1629
01:04:44,240 --> 01:04:46,040
SOMETHING FOR A DIFFERENT

1630
01:04:46,040 --> 01:04:46,320
LECTURE.

1631
01:04:46,320 --> 01:04:48,040
BUT I WANT YOU TO THINK ABOUT

1632
01:04:48,040 --> 01:04:51,120
THIS WHEN YOU'RE LOOKING AT A

1633
01:04:51,120 --> 01:04:52,480
TRIAL.

1634
01:04:52,480 --> 01:04:53,560
NEXT SLIDE PLEASE.

1635
01:04:53,560 --> 01:04:57,280
SO FOR ME AS A SPONSOR I THINK

1636
01:04:57,280 --> 01:04:57,960
ABOUT DE-RISKING TRIALS, NOT

1637
01:04:57,960 --> 01:04:59,920
TRYING TO HIT THE HOME RUN.

1638
01:04:59,920 --> 01:05:01,880
I WANT TO DE-RISK THE TRIAL AND

1639
01:05:01,880 --> 01:05:05,600
TRY TO MAKE SURE WE CAN  FINISH

1640
01:05:05,600 --> 01:05:06,800
THE TRIAL AND GET SOMETHING

1641
01:05:06,800 --> 01:05:08,120
SENSIBLE OUT OF IT.

1642
01:05:08,120 --> 01:05:10,640
AND THE COMPLEXITY OF THESE

1643
01:05:10,640 --> 01:05:16,120
TRIALS MAKE THESE TRIALS I

1644
01:05:16,120 --> 01:05:16,480
BELIEVE RISKIER.

1645
01:05:16,480 --> 01:05:17,760
AND INCREASED CHANCES ONCE WE

1646
01:05:17,760 --> 01:05:22,480
START THESE TRIALS WE CAN

1647
01:05:22,480 --> 01:05:23,360
UNCOVER EARLY UNANTICIPATED

1648
01:05:23,360 --> 01:05:24,360
SIGNALS THAT SUGGEST THERE'S A

1649
01:05:24,360 --> 01:05:27,760
PROBLEM IN HOW THE TRIAL IS

1650
01:05:27,760 --> 01:05:27,960
GOING.

1651
01:05:27,960 --> 01:05:32,240
AND ONCE AGAIN, I THINK OF THESE

1652
01:05:32,240 --> 01:05:34,440
AS QUALITY IMPROVEMENT TRIALS,

1653
01:05:34,440 --> 01:05:36,840
LOOKING AT AHRQ THERE'S A

1654
01:05:36,840 --> 01:05:40,000
PROCESS OF ENGAGING

1655
01:05:40,000 --> 01:05:40,560
STAKEHOLDERS, DEMONSTRATION

1656
01:05:40,560 --> 01:05:42,080
PROJECTS, IT'S ITERATIVE.

1657
01:05:42,080 --> 01:05:46,160
WE GO BACK AND CHANGE OR

1658
01:05:46,160 --> 01:05:48,320
REENGINEER BECAUSE OF

1659
01:05:48,320 --> 01:05:53,360
UNANTICIPATED OUTCOMES,

1660
01:05:53,360 --> 01:05:55,440
ESPECIALLY COMPLEXITY AND

1661
01:05:55,440 --> 01:05:57,960
HETEROGENEITY IN THE POPULATION.

1662
01:05:57,960 --> 01:05:59,080
IS IT OKAY TO FAIL?

1663
01:05:59,080 --> 01:06:01,360
I THINK IT'S OKAY TO FAIL.

1664
01:06:01,360 --> 01:06:03,240
IN MANY QUALITY IMPROVEMENT

1665
01:06:03,240 --> 01:06:04,440
PROJECTS WE DON'T GET IT RIGHT

1666
01:06:04,440 --> 01:06:05,520
THE FIRST TIME.

1667
01:06:05,520 --> 01:06:07,920
IF WE SEE SOMETHING NOT GOING

1668
01:06:07,920 --> 01:06:11,160
RIGHT IN THE FIRST 10 TO 20% OF

1669
01:06:11,160 --> 01:06:13,000
PATIENTS ENROLLED, IS THIS AN

1670
01:06:13,000 --> 01:06:14,400
OPPORTUNITY TO STOP AND

1671
01:06:14,400 --> 01:06:15,080
REENGINEER AND CHANGE THE COURSE

1672
01:06:15,080 --> 01:06:16,240
OF THE TRIAL?

1673
01:06:16,240 --> 01:06:18,400
IT GETS MUCH MORE DIFFICULT WHEN

1674
01:06:18,400 --> 01:06:20,000
50% OF THE POPULATION IS

1675
01:06:20,000 --> 01:06:22,520
ENROLLED BUT WHEN IT'S AT 10%

1676
01:06:22,520 --> 01:06:23,920
WE'RE JUST GETTING STARTED AND

1677
01:06:23,920 --> 01:06:25,640
THERE'S STILL A LOT OF -- IT'S

1678
01:06:25,640 --> 01:06:28,520
STILL EARLY IN THE TRIAL AND I

1679
01:06:28,520 --> 01:06:31,080
BELIEVE WE SHOULD FIND OUT

1680
01:06:31,080 --> 01:06:32,840
THINGS EARLIER AND MAKE CHANGES

1681
01:06:32,840 --> 01:06:33,120
EARLIER.

1682
01:06:33,120 --> 01:06:35,440
I THINK THAT'S THE BEST THING TO

1683
01:06:35,440 --> 01:06:42,120
HAVE A BEST TO CHANGE AND

1684
01:06:42,120 --> 01:06:42,400
REENGINEER.

1685
01:06:42,400 --> 01:06:43,840
NEXT SLIDE.

1686
01:06:43,840 --> 01:06:45,520
SO PAUSING SOME TRIALS, I JUST

1687
01:06:45,520 --> 01:06:48,920
WANT TO CLOSE OUT WITH THIS,

1688
01:06:48,920 --> 01:06:52,400
THAT TO STOP OR PAUSE OR CHANGE

1689
01:06:52,400 --> 01:06:55,600
A TRIAL, IT PLACES -- DSMB HAS

1690
01:06:55,600 --> 01:06:59,320
TO MAKE A DIFFICULT DECISION.

1691
01:06:59,320 --> 01:07:00,520
HAVING ROBUST DATA IS IMPORTANT.

1692
01:07:00,520 --> 01:07:03,920
IT HAS TO BE OBJECTIVE.

1693
01:07:03,920 --> 01:07:07,080
SO IT'S NOT ONE SIGNAL.

1694
01:07:07,080 --> 01:07:08,280
IT'S ABOUT THE TOTALITY OF ALL

1695
01:07:08,280 --> 01:07:09,480
THE DATA.

1696
01:07:09,480 --> 01:07:12,120
YOU HAVE TO LOOK AT TOTALITY AND

1697
01:07:12,120 --> 01:07:14,360
HAVE AN EXPERT GROUP OPINION AND

1698
01:07:14,360 --> 01:07:16,160
DISCUSSION ABOUT WHAT DO YOU SEE

1699
01:07:16,160 --> 01:07:16,600
HERE.

1700
01:07:16,600 --> 01:07:19,320
IT'S NOT JUST ONE ISOLATE THAT

1701
01:07:19,320 --> 01:07:19,560
TAKES OUT.

1702
01:07:19,560 --> 01:07:21,640
YOU HAVE TO THINK ABOUT THIS AS

1703
01:07:21,640 --> 01:07:23,280
A BURDEN OF PROOF.

1704
01:07:23,280 --> 01:07:26,000
IT'S NOT PREPONDERANCE OF

1705
01:07:26,000 --> 01:07:30,280
EVIDENCE, HOW IT STAYS CLEAR AND

1706
01:07:30,280 --> 01:07:32,160
CONVINCING, HIGHLY LIKELY TRUE

1707
01:07:32,160 --> 01:07:34,240
THAN UNTRUE IS I WOULD SAY THE

1708
01:07:34,240 --> 01:07:36,440
BURDEN THAT WE ARE TRYING TO

1709
01:07:36,440 --> 01:07:40,120
THINK ABOUT, WHAT DOES THE

1710
01:07:40,120 --> 01:07:45,520
TOTALITY OF DATA TELL US?

1711
01:07:45,520 --> 01:07:49,760
IT SHOULD NOT COME AS A SURPRISE

1712
01:07:49,760 --> 01:07:51,400
DSMB INVESTIGATORS SHOULD SEE

1713
01:07:51,400 --> 01:07:51,720
THIS COMING.

1714
01:07:51,720 --> 01:07:55,560
WE SHOULD DISCUSS THIS.

1715
01:07:55,560 --> 01:08:00,000
IDEALLY BEFORE, DISCUSS WHAT ARE

1716
01:08:00,000 --> 01:08:02,640
THE GOALS, ARE THERE SECONDARY

1717
01:08:02,640 --> 01:08:06,520
RESEARCH OBJECTIVES GETTING  OUT

1718
01:08:06,520 --> 01:08:09,240
OF THIS TRIAL AND DATA?

1719
01:08:09,240 --> 01:08:11,120
INVESTIGATORS ARE NOT BLINDED,

1720
01:08:11,120 --> 01:08:12,440
IT'S DIFFICULT FOR A COLLEAGUE

1721
01:08:12,440 --> 01:08:14,400
SITTING ON THE DSMB TO STOP

1722
01:08:14,400 --> 01:08:21,640
SOMEBODY ELSE'S TRIAL.

1723
01:08:21,640 --> 01:08:23,520
SO, THERE'S SOME DSMB HESITANCY

1724
01:08:23,520 --> 01:08:26,000
TO MAKE A DECISION.

1725
01:08:26,000 --> 01:08:31,400
ARE WE NOT GOING TO ANSWER THE

1726
01:08:31,400 --> 01:08:34,320
PRIMARY QUESTION, SHOULD WE

1727
01:08:34,320 --> 01:08:36,320
REBOOT OR REENGINEER OR ARE

1728
01:08:36,320 --> 01:08:44,280
THERE SECONDARY HIGH  --

1729
01:08:44,280 --> 01:08:44,600
HYPOTHESES.

1730
01:08:44,600 --> 01:08:46,480
WE USE BIOETHICIST, HELP FOLLOW

1731
01:08:46,480 --> 01:08:48,520
ASK IF WE ASKED PATIENTS TO GIVE

1732
01:08:48,520 --> 01:08:49,880
THEIR TIME, ASKED HEALTH CARE

1733
01:08:49,880 --> 01:08:51,720
PROVIDERS TO GIVE TIME AND

1734
01:08:51,720 --> 01:08:52,600
RESOURCES, AND WE'VE ASKED THEM

1735
01:08:52,600 --> 01:08:56,560
TO BE PART OF THIS BIGGER STUDY

1736
01:08:56,560 --> 01:08:57,400
TO ANSWER A CERTAIN QUESTION AND

1737
01:08:57,400 --> 01:09:00,160
WE WANT TO BE ABLE TO SAY THAT

1738
01:09:00,160 --> 01:09:01,680
WE CAN ETHICALLY AND

1739
01:09:01,680 --> 01:09:02,360
REALISTICALLY ANSWER THIS

1740
01:09:02,360 --> 01:09:04,280
QUESTION GIVEN WHERE WE ARE

1741
01:09:04,280 --> 01:09:04,760
TODAY.

1742
01:09:04,760 --> 01:09:06,720
THE LAST THING, IT'S NOT

1743
01:09:06,720 --> 01:09:07,920
PERSONAL, BUT INVESTIGATORS WILL

1744
01:09:07,920 --> 01:09:10,560
SURE FEEL THAT WAY IF THERE'S A

1745
01:09:10,560 --> 01:09:13,680
MAJOR CHANGE IN THE COURSE OF

1746
01:09:13,680 --> 01:09:15,040
THE DSMB RECOMMENDATIONS.

1747
01:09:15,040 --> 01:09:16,440
NEXT SLIDE.

1748
01:09:16,440 --> 01:09:17,760
WITH THAT, I'LL END MY TALK AND

1749
01:09:17,760 --> 01:09:22,320
THANK YOU FOR HAVING ME.

1750
01:09:22,320 --> 01:09:26,640
>> THANK YOU SO MUCH,
KEVIN.

1751
01:09:26,640 --> 01:09:28,160
NEXT UP DR. SHERYL BOYCE, WHO

1752
01:09:28,160 --> 01:09:30,160
WILL GIVE US THE PERSPECTIVE

1753
01:09:30,160 --> 01:09:31,720
FROM OFFICE OF STRATEGIC

1754
01:09:31,720 --> 01:09:40,200
COORDINATION AT THE COMMON FUND.

1755
01:09:40,200 --> 01:09:42,040
>> IN THINKING ABOUT WHAT
WE'RE

1756
01:09:42,040 --> 01:09:43,480
TALKING ABOUT TODAY I WANTED TO

1757
01:09:43,480 --> 01:09:46,440
ALSO ADD IN TERMS OF SOME OF THE

1758
01:09:46,440 --> 01:09:48,080
CHALLENGES NOT ONLY THE DATA

1759
01:09:48,080 --> 01:09:50,520
THAT WE MIGHT TRADITIONALLY

1760
01:09:50,520 --> 01:09:55,680
THINK ABOUT BUT ALSO VALUE OF

1761
01:09:55,680 --> 01:09:57,160
QUALITATIVE DATA, CONTEXT, IN

1762
01:09:57,160 --> 01:09:58,360
TERMS OF DIFFERENT POPULATIONS

1763
01:09:58,360 --> 01:10:00,120
AND ROLES OF PATIENTS AND

1764
01:10:00,120 --> 01:10:01,920
COMMUNITIES AND HOW THAT CAN BE

1765
01:10:01,920 --> 01:10:04,120
IMPORTANT IN TERMS OF WHAT WE DO

1766
01:10:04,120 --> 01:10:06,160
IN TERMS OF EARLY SIGNALS AND

1767
01:10:06,160 --> 01:10:08,440
HOW WE MAKE CONSIDERATIONS FOR

1768
01:10:08,440 --> 01:10:09,560
HOW WE ACT.

1769
01:10:09,560 --> 01:10:12,040
IN TERMS OF THE DIFFERENT

1770
01:10:12,040 --> 01:10:14,360
LEVELS, WE HAVE PATIENTS,

1771
01:10:14,360 --> 01:10:15,560
PRACTITIONERS, TEAMS, HEALTH

1772
01:10:15,560 --> 01:10:17,520
SYSTEMS, AND COMMUNITIES WHO ARE

1773
01:10:17,520 --> 01:10:19,720
ALL A PART OF PRAGMATIC TRIALS

1774
01:10:19,720 --> 01:10:22,680
AND THE DECISIONS THAT WE MAKE.

1775
01:10:22,680 --> 01:10:24,960
AND ALSO THINKING ABOUT

1776
01:10:24,960 --> 01:10:25,960
INVOLVING SOMEWHAT OF OUR

1777
01:10:25,960 --> 01:10:26,960
COMMUNITY BASE REVIEW PROCESS

1778
01:10:26,960 --> 01:10:29,120
AND HOW WE MAKE SOME OF THESE

1779
01:10:29,120 --> 01:10:29,920
DECISIONS.

1780
01:10:29,920 --> 01:10:33,200
WE DO THINK ABOUT COMMUNITY

1781
01:10:33,200 --> 01:10:34,400
BASED RESEARCH AND

1782
01:10:34,400 --> 01:10:36,040
PATIENT-INVOLVED RESEARCH IN NEW

1783
01:10:36,040 --> 01:10:38,840
WAYS, ESPECIALLY AS WE'RE

1784
01:10:38,840 --> 01:10:39,640
REENGINEERING RESEARCH

1785
01:10:39,640 --> 01:10:41,760
ENTERPRISE WITHIN THE OFFICE OF

1786
01:10:41,760 --> 01:10:42,720
STRATEGIC COORDINATION OR COMMON

1787
01:10:42,720 --> 01:10:45,440
FUND WE ARE MOST RECENTLY HAVE A

1788
01:10:45,440 --> 01:10:47,520
COMMUNITY PARTNERSHIP TO ADVANCE

1789
01:10:47,520 --> 01:10:50,440
SCIENCE FOR SOCIETY WHERE WE ARE

1790
01:10:50,440 --> 01:10:51,680
FUNDING COMMUNITIES DIRECTLY TO

1791
01:10:51,680 --> 01:10:54,520
GIVE THEM MORE POWER IN THE

1792
01:10:54,520 --> 01:10:55,440
ACTUAL RESEARCH PROCESS.

1793
01:10:55,440 --> 01:10:57,280
BUT IN TERMS OF THINKING ABOUT

1794
01:10:57,280 --> 01:10:59,240
SOME OF THE INDIVIDUAL AND

1795
01:10:59,240 --> 01:11:01,320
COMMUNITY LEVEL PROTECTIONS AND

1796
01:11:01,320 --> 01:11:04,480
ETHICS, AND ALSO TO REALLY

1797
01:11:04,480 --> 01:11:07,120
ENHANCE WHAT WE DO, AND ENHANCE

1798
01:11:07,120 --> 01:11:10,160
AND BUILD OUR CAPACITY AND HOW

1799
01:11:10,160 --> 01:11:12,160
WE WORK WITHIN DIFFERENT

1800
01:11:12,160 --> 01:11:13,120
COMMUNITIES AND PATIENT

1801
01:11:13,120 --> 01:11:14,880
COMMUNITIES TO SHAPE OUR

1802
01:11:14,880 --> 01:11:18,960
RESEARCH, AND REALLY THINK ABOUT

1803
01:11:18,960 --> 01:11:19,840
SUSTAINABILITY THAT EFFECTIVE

1804
01:11:19,840 --> 01:11:21,360
COMMUNITY REVIEW MAY BE

1805
01:11:21,360 --> 01:11:21,600
IMPORTANT.

1806
01:11:21,600 --> 01:11:23,520
AND THAT COMMUNITY CAN BE

1807
01:11:23,520 --> 01:11:25,040
DEFINED IN DIFFERENT WAYS, BUT

1808
01:11:25,040 --> 01:11:27,440
THINKING ABOUT THAT IN TERMS OF

1809
01:11:27,440 --> 01:11:28,680
WHAT ARE THE OPPORTUNITIES IN

1810
01:11:28,680 --> 01:11:32,400
TERMS OF THE CHALLENGES THAT WE

1811
01:11:32,400 --> 01:11:34,280
FACE WITH DETECTING EARLY

1812
01:11:34,280 --> 01:11:34,800
SIGNALS.

1813
01:11:34,800 --> 01:11:39,720
AND AS WE THINK ABOUT HOW WE MAY

1814
01:11:39,720 --> 01:11:42,120
PROCEED, UNDERSTANDING AS WE

1815
01:11:42,120 --> 01:11:44,560
MOVE FORWARD INTO IMPLEMENTATION

1816
01:11:44,560 --> 01:11:47,360
AND SUSTAINABILITY THAT THERE'S

1817
01:11:47,360 --> 01:11:50,200
THE ROLE OF DEIMPLEMENTATION,

1818
01:11:50,200 --> 01:11:51,840
AND THAT NO MATTER WHAT THERE

1819
01:11:51,840 --> 01:11:52,960
WAS SOMETHING ELSE THAT PEOPLE

1820
01:11:52,960 --> 01:11:55,440
WERE DOING, WHETHER IT MAY BE

1821
01:11:55,440 --> 01:11:58,240
DIFFERENT TREATMENT OR DIFFERENT

1822
01:11:58,240 --> 01:11:59,760
BEHAVIORS, AND THOSE ALL PLAY

1823
01:11:59,760 --> 01:12:03,040
VERY WELL INTO HOW WE MAY BE

1824
01:12:03,040 --> 01:12:05,880
ABLE TO SUSTAIN OR ACT IN TERMS

1825
01:12:05,880 --> 01:12:09,200
OF THE FINDINGS THAT WE HAVE.

1826
01:12:09,200 --> 01:12:10,480
AND MAKING SURE THOSE ARE

1827
01:12:10,480 --> 01:12:18,960
CONSIDERED AND  THAT THERE'S

1828
01:12:18,960 --> 01:12:23,320
INTROSPECTION AS WE MOVE

1829
01:12:23,320 --> 01:12:23,760
FORWARD.

1830
01:12:23,760 --> 01:12:26,400
IMPACT ON SOMETHING STARTING

1831
01:12:26,400 --> 01:12:29,880
EARLY OR STOPPING REALLY CAN BE

1832
01:12:29,880 --> 01:12:32,840
QUITE PROFOUND, AND WITHOUT

1833
01:12:32,840 --> 01:12:34,240
INVOLVING PATIENTS AND

1834
01:12:34,240 --> 01:12:35,680
COMMUNITIES THROUGHOUT THE

1835
01:12:35,680 --> 01:12:38,640
PROCESS WE REALLY ARE LACKING AN

1836
01:12:38,640 --> 01:12:39,680
IMPORTANT PERSPECTIVE.

1837
01:12:39,680 --> 01:12:42,360
IMPORTANT PERSPECTIVE THAT COULD

1838
01:12:42,360 --> 01:12:45,120
BE AN OPPORTUNITY TO STRENGTHEN.

1839
01:12:45,120 --> 01:12:49,600
AND HOW WE DESIGN OR ADAPT OR

1840
01:12:49,600 --> 01:12:53,040
THINK ABOUT HOW WE MIGHT CHANGE

1841
01:12:53,040 --> 01:12:54,680
IN TERMS OF WHEN WE PLAN AND

1842
01:12:54,680 --> 01:12:56,080
WHEN WE DO.

1843
01:12:56,080 --> 01:12:57,760
AND WE ALSO HAVE A GREAT

1844
01:12:57,760 --> 01:12:59,920
OPPORTUNITY IN TERMS OF THE

1845
01:12:59,920 --> 01:13:03,760
CONSIDERATIONS AND WHEN WE DO

1846
01:13:03,760 --> 01:13:05,040
HAVE TO ACTUALLY PROCEED WITH

1847
01:13:05,040 --> 01:13:09,320
MAKING A CHANGE IN TERMS OF

1848
01:13:09,320 --> 01:13:10,520
ADAPTATION OR STOPPING A TRIAL.

1849
01:13:10,520 --> 01:13:16,440
SO WITH THAT I REALLY WANTED TO

1850
01:13:16,440 --> 01:13:17,320
ENCOURAGE SOME ADDITIONAL

1851
01:13:17,320 --> 01:13:18,960
PERSPECTIVES ACROSS THE LEVELS

1852
01:13:18,960 --> 01:13:20,160
THAT INFORM WITH COMMUNITY

1853
01:13:20,160 --> 01:13:23,120
REVIEWS AND THOSE WITH LIVED

1854
01:13:23,120 --> 01:13:24,400
EXPERIENCE THAT MAY INFORM HOW

1855
01:13:24,400 --> 01:13:27,600
WE PROCEED AND SOME OF THE

1856
01:13:27,600 --> 01:13:28,680
RECOMMENDATIONS THAT WE MOVE

1857
01:13:28,680 --> 01:13:37,360
FORTH WITH, WITH THE PANEL

1858
01:13:37,360 --> 01:13:39,440
TODAY.

1859
01:13:39,440 --> 01:13:39,720
THANK YOU.

1860
01:13:39,720 --> 01:13:41,760
>> THANK YOU, CHERYL.

1861
01:13:41,760 --> 01:13:51,240
LET'S GO FROM BIOETHICS

1862
01:13:51,240 --> 01:13:54,640
PERSPECTIVE FROM COLLABORATORY

1863
01:13:54,640 --> 01:13:55,920
COLLEAGUE, PEARL O'ROURKE.

1864
01:13:55,920 --> 01:13:57,800
>> I HAVE SLIDES.

1865
01:13:57,800 --> 01:13:58,480
THANK YOU.

1866
01:13:58,480 --> 01:14:00,200
I WANT TO SPEND A FEW MINUTES

1867
01:14:00,200 --> 01:14:03,600
TALKING ABOUT THE ETHICAL AND

1868
01:14:03,600 --> 01:14:04,280
REGULATORY CONSIDERATIONS FOR

1869
01:14:04,280 --> 01:14:06,240
PIVOTING ON A STUDY.

1870
01:14:06,240 --> 01:14:08,200
BOTTOM LINE, THERE'S ETHICAL AND

1871
01:14:08,200 --> 01:14:09,440
REGULATORY REASONS FOR PIVOTING.

1872
01:14:09,440 --> 01:14:13,040
EVERYTHING IS IN FAVOR OF

1873
01:14:13,040 --> 01:14:13,800
PIVOTING.

1874
01:14:13,800 --> 01:14:14,240
NEXT SLIDE PLEASE.

1875
01:14:14,240 --> 01:14:15,760
>>PEARL, IF YOU PAUSE FOR
A

1876
01:14:15,760 --> 01:14:18,720
SECOND, WE HAVE TO GET IT OUT OF

1877
01:14:18,720 --> 01:14:19,240
PRESENTER MODE THERE.

1878
01:14:19,240 --> 01:14:20,760
>> THAT'S SOMETHING YOU
HAVE TO

1879
01:14:20,760 --> 01:14:22,160
DO OR I HAVE TO DO?

1880
01:14:22,160 --> 01:14:27,040
>> I THINK WE DO IT ON
OUR END.

1881
01:14:27,040 --> 01:14:29,160
>> I'LL JUST KEEP
TALKING, IF

1882
01:14:29,160 --> 01:14:30,440
THAT'S OKAY.

1883
01:14:30,440 --> 01:14:30,720
>> SURE.

1884
01:14:30,720 --> 01:14:31,880
>> ALL RIGHT.

1885
01:14:31,880 --> 01:14:33,640
JUST TO REMIND EVERYBODY, THE

1886
01:14:33,640 --> 01:14:34,960
REAL BASIC QUESTIONS THAT YOU

1887
01:14:34,960 --> 01:14:37,360
HAVE TO LOOK AT IF YOU'RE DOING

1888
01:14:37,360 --> 01:14:40,640
A STUDY, FROM ETHICS AND

1889
01:14:40,640 --> 01:14:42,400
REGULATION, IS -- NOW WE'VE

1890
01:14:42,400 --> 01:14:44,280
TOTALLY DISAPPEARED -- IS

1891
01:14:44,280 --> 01:14:48,000
LOOKING AT THE RISK/BENEFIT

1892
01:14:48,000 --> 01:14:48,840
ANALYSIS.

1893
01:14:48,840 --> 01:14:51,080
AND BOTH FOR ETHICAL REASONS AS

1894
01:14:51,080 --> 01:14:54,320
WELL AS REGULATORY, YOU WANT TO

1895
01:14:54,320 --> 01:14:55,440
MAXIMIZE BENEFIT, THE QUESTION

1896
01:14:55,440 --> 01:14:57,520
THERE IS THE STUDY WORTHWHILE

1897
01:14:57,520 --> 01:14:59,280
DOING, DOES IT MATTER, WILL IT

1898
01:14:59,280 --> 01:15:00,120
BE IMPLEMENTED?

1899
01:15:00,120 --> 01:15:01,440
WE TALKED YESTERDAY ABOUT

1900
01:15:01,440 --> 01:15:01,920
IMPLEMENTATION.

1901
01:15:01,920 --> 01:15:04,960
I DON'T KNOW IF WE LOOKED AT

1902
01:15:04,960 --> 01:15:06,360
THAT IN ENOUGH DETAIL.

1903
01:15:06,360 --> 01:15:08,000
YOU WANT TO DECREASE RISK.

1904
01:15:08,000 --> 01:15:10,960
I THINK WHAT ONE OF THE POINTS

1905
01:15:10,960 --> 01:15:12,760
KEVIN MADE JUST NOW IS RELEVANT

1906
01:15:12,760 --> 01:15:17,080
IN TERMS OF, YOU KNOW, IF IT'S

1907
01:15:17,080 --> 01:15:18,840
GOING BAD, EVEN IF MINOR RISK,

1908
01:15:18,840 --> 01:15:20,040
SHOULDN'T BE DONE.

1909
01:15:20,040 --> 01:15:22,480
ANY RISK IS NOT APPROPRIATE IF

1910
01:15:22,480 --> 01:15:24,000
THERE'S GOING TO BE NO BENEFIT.

1911
01:15:24,000 --> 01:15:31,320
DOWN TO THE NEXT SLIDE PLEASE.

1912
01:15:31,320 --> 01:15:32,320
OKAY.

1913
01:15:32,320 --> 01:15:36,800
ONE BEFORE THAT. 

1914
01:15:36,800 --> 01:15:37,560
FABULOUS, OKAY.

1915
01:15:37,560 --> 01:15:39,560
SO, BASICALLY, I THINK ALSO AS

1916
01:15:39,560 --> 01:15:41,200
KEVIN NOTED, IF YOU KNOW THE

1917
01:15:41,200 --> 01:15:43,240
ANSWER, YOU SHOULDN'T BE DOING

1918
01:15:43,240 --> 01:15:44,600
THE RESEARCH.

1919
01:15:44,600 --> 01:15:45,640
IT'S NOT ETHICALLY APPROPRIATE

1920
01:15:45,640 --> 01:15:47,200
TO HAVE PEOPLE GO THROUGH ANY

1921
01:15:47,200 --> 01:15:48,800
LEVEL OF RISK.

1922
01:15:48,800 --> 01:15:51,880
THE OTHER IS TRANSPARENCY AND

1923
01:15:51,880 --> 01:15:52,120
HONESTY.

1924
01:15:52,120 --> 01:15:52,920
IT TALKED ABOUT COMMUNITY

1925
01:15:52,920 --> 01:15:53,200
GROUPS.

1926
01:15:53,200 --> 01:15:57,000
I THINK THAT'S PART OF THE

1927
01:15:57,000 --> 01:15:57,280
ANSWER.

1928
01:15:57,280 --> 01:15:59,080
WE TALK ABOUT PRAGMATIC TRIALS,

1929
01:15:59,080 --> 01:16:01,720
MUCH GETS A WAIVER OF INFORMED

1930
01:16:01,720 --> 01:16:04,880
CONSENT SO IT'S BECOME THE

1931
01:16:04,880 --> 01:16:07,120
STICKIER WICKET IN TERMS OF DO

1932
01:16:07,120 --> 01:16:09,400
YOU NOTIFY OR NOT.

1933
01:16:09,400 --> 01:16:12,800
IT'S ALWAYS REASONABLE TO TELL

1934
01:16:12,800 --> 01:16:14,200
PEOPLE, POSSIBILITY OF CHANGE,

1935
01:16:14,200 --> 01:16:16,080
POSSIBILITY OF EARLY

1936
01:16:16,080 --> 01:16:17,040
TERMINATION, WHAT HAPPENS TO

1937
01:16:17,040 --> 01:16:19,200
THAT PERSON?

1938
01:16:19,200 --> 01:16:20,520
NEXT SLIDE PLEASE.

1939
01:16:20,520 --> 01:16:21,160
THANK YOU.

1940
01:16:21,160 --> 01:16:24,360
ONE OF THE ISSUES ABOUT IRB

1941
01:16:24,360 --> 01:16:28,040
REVIEW YOU ALL KNOW IT'S

1942
01:16:28,040 --> 01:16:28,360
FRONT-ENDED.

1943
01:16:28,360 --> 01:16:29,040
YOU'RE SUBMITTING YOUR BEST

1944
01:16:29,040 --> 01:16:30,880
GUESS OF THE WAY THINGS WILL GO,

1945
01:16:30,880 --> 01:16:32,920
BUT NOT UNTIL YOU HAVE BOOTS ON

1946
01:16:32,920 --> 01:16:37,080
THE GROUND DO YOU REALLY HAVE AN

1947
01:16:37,080 --> 01:16:39,480
IDEA, BETTER GRASP OF WHAT IS

1948
01:16:39,480 --> 01:16:40,000
HAPPENING.

1949
01:16:40,000 --> 01:16:42,200
THE IRB IS ONLY LOOKING AT FRONT

1950
01:16:42,200 --> 01:16:45,080
END BEFORE IT GIVES YOU

1951
01:16:45,080 --> 01:16:45,360
APPROVAL.

1952
01:16:45,360 --> 01:16:46,360
REVIEW DOES INCLUDE STUDY

1953
01:16:46,360 --> 01:16:47,560
DESIGN.

1954
01:16:47,560 --> 01:16:48,760
WE TALKED ABOUT SECONDARY AIMS,

1955
01:16:48,760 --> 01:16:51,280
IF YOU HAVE OTHER AIMS OF THE

1956
01:16:51,280 --> 01:16:52,720
STUDY YOU SHOULD INCLUDE THAT,

1957
01:16:52,720 --> 01:16:53,920
JUST SAY SO.

1958
01:16:53,920 --> 01:16:57,360
AND THE IRB LOOKS AT CONTEXT.

1959
01:16:57,360 --> 01:17:00,920
WHAT YOU'RE PROPOSING TO DO IS

1960
01:17:00,920 --> 01:17:01,440
ACTUALLY RESEARCH VERSUS

1961
01:17:01,440 --> 01:17:05,400
STANDARD OF CARE THAT WOULD

1962
01:17:05,400 --> 01:17:07,920
HAPPEN ANYWAY.

1963
01:17:07,920 --> 01:17:09,120
RELEVANT POLICIES, WE GOT A GOOD

1964
01:17:09,120 --> 01:17:11,880
TALK IN TERMS OF STOP CRC,

1965
01:17:11,880 --> 01:17:13,920
POLICIES THAT CAME INTO PLAY.

1966
01:17:13,920 --> 01:17:15,560
RELATED RESEARCH, IF THERE'S

1967
01:17:15,560 --> 01:17:16,840
ALREADY BEEN EXTRAORDINARILY

1968
01:17:16,840 --> 01:17:21,160
GOOD RESEARCH THAT GIVES YOU THE

1969
01:17:21,160 --> 01:17:22,760
ANSWER, PERHAPS RESEARCH SHOULD

1970
01:17:22,760 --> 01:17:25,000
NOT BE DONE.

1971
01:17:25,000 --> 01:17:25,600
AGAIN, IMPLEMENTATION ISSUES.

1972
01:17:25,600 --> 01:17:28,040
NEXT SLIDE PLEASE.

1973
01:17:28,040 --> 01:17:30,840
NOW, ETHICAL REVIEW, ETHICS AND

1974
01:17:30,840 --> 01:17:32,520
REGULATORY ISSUES CONTINUE

1975
01:17:32,520 --> 01:17:35,160
THROUGH THE ENTIRE LIFE OF THE

1976
01:17:35,160 --> 01:17:37,560
PROTOCOL AND NOT JUST INITIAL

1977
01:17:37,560 --> 01:17:37,880
IRB APPROVAL.

1978
01:17:37,880 --> 01:17:40,640
AND I THINK YOU HAD GREAT

1979
01:17:40,640 --> 01:17:44,040
EXAMPLES HOW CIRCUMSTANCES CAN

1980
01:17:44,040 --> 01:17:45,000
CHANGE.

1981
01:17:45,000 --> 01:17:50,800
OBVIOUSLY COVID THROUGH A MAJOR

1982
01:17:50,800 --> 01:17:53,960
SAND INTO THE GEARS OF RESEARCH,

1983
01:17:53,960 --> 01:17:55,160
NEW RELEVANT POLICIES AGAIN I

1984
01:17:55,160 --> 01:18:00,000
WOULD GO TO THE STOP CRC HAS AN

1985
01:18:00,000 --> 01:18:00,560
EXAMPLE.

1986
01:18:00,560 --> 01:18:03,200
INFORMATIVE NEW RESEARCH, IRBs

1987
01:18:03,200 --> 01:18:04,240
RELY ON INVESTIGATORS TO HELP.

1988
01:18:04,240 --> 01:18:07,440
WHAT HAS HAPPENED IN THE

1989
01:18:07,440 --> 01:18:07,800
INTERIM?

1990
01:18:07,800 --> 01:18:10,280
HAVE NEW STUDIES COME OUT?

1991
01:18:10,280 --> 01:18:12,800
HAVE YOU FOUND OUT THE STUDY IS

1992
01:18:12,800 --> 01:18:16,280
NO LONGER FEASIBLE OR YOU CAN'T

1993
01:18:16,280 --> 01:18:17,240
DO IT FOR, YOU KNOW, JUST WHEN

1994
01:18:17,240 --> 01:18:21,240
YOU MADE THE DESIGN YOU DID YOUR

1995
01:18:21,240 --> 01:18:22,720
BEST EFFORT, UNFORTUNATELY IT

1996
01:18:22,720 --> 01:18:25,160
DOESN'T MEET WELL ARE REAL LIFE.

1997
01:18:25,160 --> 01:18:27,680
ALSO ARE THERE INTERIM RESULTS

1998
01:18:27,680 --> 01:18:28,680
THAT SUGGEST THAT, WELL, MAYBE

1999
01:18:28,680 --> 01:18:30,160
YOU ALREADY HAVE YOUR ANSWER AND

2000
01:18:30,160 --> 01:18:32,400
YOU CAN STOP THE STUDY EARLIER,

2001
01:18:32,400 --> 01:18:34,200
OR ELSE IT'S JUST NOT FEASIBLE

2002
01:18:34,200 --> 01:18:38,440
TO CONTINUE.

2003
01:18:38,440 --> 01:18:40,040
NEXT SLIDE PLEASE.

2004
01:18:40,040 --> 01:18:42,040
SO WHAT TO DO.

2005
01:18:42,040 --> 01:18:46,120
THERE'S DEFINITELYETHICAL AND

2006
01:18:46,120 --> 01:18:52,680
REGULATORY SUPPORT TO PIVOT.

2007
01:18:52,680 --> 01:18:55,440
THE THING ABOUT PIVOTING, YOU DO

2008
01:18:55,440 --> 01:18:58,160
MAXIMIZE BENEFIT, MAKING THE

2009
01:18:58,160 --> 01:18:59,600
INTERVENTION EARLIER TO OTHERS,

2010
01:18:59,600 --> 01:19:01,760
REMEMBERING RESEARCH IS GOING

2011
01:19:01,760 --> 01:19:04,400
FOR GENERALIZABLE KNOWLEDGE, NOT

2012
01:19:04,400 --> 01:19:05,960
JUST AT YOUR INSTITUTION,

2013
01:19:05,960 --> 01:19:06,960
HOPEFULLY OTHER INSTITUTIONS,

2014
01:19:06,960 --> 01:19:09,560
AND MAKING IT A STANDARD OF CARE

2015
01:19:09,560 --> 01:19:11,560
ELSEWHERE, AND IT WOULD BE A

2016
01:19:11,560 --> 01:19:13,080
GREAT BENEFIT.

2017
01:19:13,080 --> 01:19:15,480
YOU ALSO MINIMIZE RISK IN THAT

2018
01:19:15,480 --> 01:19:17,360
BOTH TO ENROLLED PARTICIPANTS

2019
01:19:17,360 --> 01:19:19,000
YOU CAN SAY, OKAY, WE'RE NO

2020
01:19:19,000 --> 01:19:21,160
LONGER IN A STUDY, YOU NO LONGER

2021
01:19:21,160 --> 01:19:22,880
HAVE TO MAKE OUT SURVEYS, NO

2022
01:19:22,880 --> 01:19:24,480
LONGER HAVE TO LOOK AT MEDICAL

2023
01:19:24,480 --> 01:19:27,200
RECORDS AND ALSO ENROLL FEWER

2024
01:19:27,200 --> 01:19:27,640
PARTICIPANTS.

2025
01:19:27,640 --> 01:19:31,120
BUT I REALLY WANT PEOPLE TO BE

2026
01:19:31,120 --> 01:19:32,440
CAREFUL BECAUSE PIVOTING, YOU

2027
01:19:32,440 --> 01:19:37,720
REALLY NEED TO HAVE A GOOD

2028
01:19:37,720 --> 01:19:39,440
JUSTIFICATION.

2029
01:19:39,440 --> 01:19:44,160
AND I THINK CORITA MADE THE

2030
01:19:44,160 --> 01:19:46,280
COMMENT THERE'S A DANGER TO

2031
01:19:46,280 --> 01:19:47,720
PIVOTING TOO SOON, ARE YOU

2032
01:19:47,720 --> 01:19:49,080
GETTING A SIGNAL, HARD TO TELL

2033
01:19:49,080 --> 01:19:53,320
NOISE FROM SICK  -- SIGNAL AT

2034
01:19:53,320 --> 01:19:54,080
SOME POINT.

2035
01:19:54,080 --> 01:19:57,600
JUSTIFICATION IN MY MIND SHOULD

2036
01:19:57,600 --> 01:20:01,520
INCLUDE THOSE SAVVY WITH STUDY

2037
01:20:01,520 --> 01:20:02,520
DESIGN, YOUR STATISTICIAN, IS

2038
01:20:02,520 --> 01:20:05,280
THIS A GOOD MOVE TO MAKE.

2039
01:20:05,280 --> 01:20:08,120
TONGUE IN CHEEK, TRY TO AVOID

2040
01:20:08,120 --> 01:20:10,600
ERRORS OF ENTHUSIASM.

2041
01:20:10,600 --> 01:20:15,320
I THINK AS PEOPLE START FIRST

2042
01:20:15,320 --> 01:20:17,440
FOUR OR FORTY PARTICIPANTS,

2043
01:20:17,440 --> 01:20:19,720
GOING TERRIFICALLY, CAN BE

2044
01:20:19,720 --> 01:20:20,840
TEMPTING TO SAY, WOW, WE ALREADY

2045
01:20:20,840 --> 01:20:24,080
HAVE THE ANSWER AND YOU NEED TO

2046
01:20:24,080 --> 01:20:27,360
GO BACK TO THE STUDY TEAM AND

2047
01:20:27,360 --> 01:20:28,960
EMPHASIS WITH STATISTICIANS.

2048
01:20:28,960 --> 01:20:32,080
ANY CHANGE TO THE IRB, RESEARCH

2049
01:20:32,080 --> 01:20:38,760
PROTOCOL, NEEDS IRB APPROVAL. 

2050
01:20:38,760 --> 01:20:43,880
THE IRB MAY WELL - AMENDMENT TO

2051
01:20:43,880 --> 01:20:45,000
INITIAL PROTOCOL MAY BE ALL

2052
01:20:45,000 --> 01:20:45,720
THAT'S NEEDED.

2053
01:20:45,720 --> 01:20:48,640
SOME BECOME LIKE CORAL REEFS,

2054
01:20:48,640 --> 01:20:50,200
HAVE YOU INITIAL PROTOCOL, ADD

2055
01:20:50,200 --> 01:20:51,920
ON, ADD ON, AT SOME POINT THIS

2056
01:20:51,920 --> 01:20:54,440
MAY BECOME THE NEW PROTOCOL SO

2057
01:20:54,440 --> 01:20:58,080
YOU MAY BE ASKED TO WRITE A NEW

2058
01:20:58,080 --> 01:20:58,400
PROTOCOL.

2059
01:20:58,400 --> 01:21:00,960
REMEMBER WITH CHANGES, IT MAY

2060
01:21:00,960 --> 01:21:02,440
CHANGE THE RISK/BENEFIT

2061
01:21:02,440 --> 01:21:02,760
ANALYSIS.

2062
01:21:02,760 --> 01:21:08,920
AND  SUDDENLY YOU MAY NOW BE MOE

2063
01:21:08,920 --> 01:21:10,680
THAN MINIMAL RISK, WHAT WAS

2064
01:21:10,680 --> 01:21:12,560
APPROVED AS WAIVER OF INFORMED

2065
01:21:12,560 --> 01:21:14,520
CONSENT, NOW YOU WOULD HAVE TO

2066
01:21:14,520 --> 01:21:16,080
GET INFORMED CONSENT.

2067
01:21:16,080 --> 01:21:20,320
AS YOU ALTER PROTOCOL DO

2068
01:21:20,320 --> 01:21:21,720
REMEMBER THE ANALYSIS MAY ALSO

2069
01:21:21,720 --> 01:21:23,040
ALTER WITH THAT.

2070
01:21:23,040 --> 01:21:25,080
NEXT SLIDE PLEASE.

2071
01:21:25,080 --> 01:21:27,720
THE CHALLENGES I SEE WITH

2072
01:21:27,720 --> 01:21:30,240
PRAGMATIC TRIALS AND I THINK

2073
01:21:30,240 --> 01:21:31,560
KEVIN WENT THROUGH A LONG LIST

2074
01:21:31,560 --> 01:21:34,000
OF MANY OF THE CHALLENGES, BUT

2075
01:21:34,000 --> 01:21:37,360
FOR THE IRB AND I THINK FOR

2076
01:21:37,360 --> 01:21:38,480
ANYONE LOOKING AT ETHICAL

2077
01:21:38,480 --> 01:21:41,440
ISSUES, MOST OF THE TRIALS ARE

2078
01:21:41,440 --> 01:21:42,160
MULTI-SITE.

2079
01:21:42,160 --> 01:21:43,520
SOME ARE MULTI-SITE WITHIN A

2080
01:21:43,520 --> 01:21:46,920
SYSTEM SO YOU MAY HAVE MORE

2081
01:21:46,920 --> 01:21:48,000
STANDARDIZATION.

2082
01:21:48,000 --> 01:21:50,080
BUT MANY ARE MULTI-SITE BETWEEN

2083
01:21:50,080 --> 01:21:50,800
DIFFERENT STATES, DIFFERENT

2084
01:21:50,800 --> 01:21:54,120
SYSTEMS, DIFFERENT TYPES OF

2085
01:21:54,120 --> 01:21:54,560
ORGANIZATIONS.

2086
01:21:54,560 --> 01:21:57,040
AND YOU HAVE INCREDIBLE

2087
01:21:57,040 --> 01:21:59,240
VARIATION OF THINGS, I LISTED

2088
01:21:59,240 --> 01:22:01,040
SOME HERE.

2089
01:22:01,040 --> 01:22:05,080
BUT THE STANDARD OF PRACTICE IN

2090
01:22:05,080 --> 01:22:08,520
SOME INTUITIONS YOUR RESEARCH

2091
01:22:08,520 --> 01:22:17,000
PROTOCOL MAY ACTUALLY BE THE

2092
01:22:17,000 --> 01:22:18,040
STANDARD.

2093
01:22:18,040 --> 01:22:20,480
IN OTHERS, SOMETHING THEY NEVER

2094
01:22:20,480 --> 01:22:21,320
ACTUALLY PROVIDED.

2095
01:22:21,320 --> 01:22:22,680
SORRY, MY DOG IS BARKING.

2096
01:22:22,680 --> 01:22:23,680
SORRY FOR THAT.

2097
01:22:23,680 --> 01:22:28,040
THERE MAY BE VARIATIONS IN LOCAL

2098
01:22:28,040 --> 01:22:29,800
POLICIES.

2099
01:22:29,800 --> 01:22:33,520
ALSO RESOURCES FOR

2100
01:22:33,520 --> 01:22:33,880
IMPLEMENTATION.

2101
01:22:33,880 --> 01:22:37,360
AND THE CHALLENGE, OTHER THAN MY

2102
01:22:37,360 --> 01:22:39,240
DOG, IS SINGLE IRB REVIEW.

2103
01:22:39,240 --> 01:22:42,280
I THINK IT'S VERY DIFFICULT FOR

2104
01:22:42,280 --> 01:22:44,920
ONE SINGLE IRB TO BE ASSESSING

2105
01:22:44,920 --> 01:22:48,520
ALL OF THESE CHALLENGES,

2106
01:22:48,520 --> 01:22:51,280
CONTEXTUAL CHALLENGES, FOR

2107
01:22:51,280 --> 01:22:51,600
INSTITUTIONS.

2108
01:22:51,600 --> 01:22:54,760
MY FINAL SLIDE, PLEASE.

2109
01:22:54,760 --> 01:22:57,600
SO, MY SUMMARY IS DEFINITELY

2110
01:22:57,600 --> 01:22:57,800
PIVOT.

2111
01:22:57,800 --> 01:22:59,800
IF IT'S NOT WORKING, CHANGE IT.

2112
01:22:59,800 --> 01:23:02,080
IF YOU'RE GETTING THE ANSWER,

2113
01:23:02,080 --> 01:23:03,720
STOP IT.

2114
01:23:03,720 --> 01:23:06,240
AND DEFINITELY INVOLVE YOUR

2115
01:23:06,240 --> 01:23:07,880
TEAM, YOUR STATISTICIANS, AND

2116
01:23:07,880 --> 01:23:09,320
REALIZE THE IRB DEFINITELY NEEDS

2117
01:23:09,320 --> 01:23:11,280
TO BE INVOLVED IN ANY DECISION

2118
01:23:11,280 --> 01:23:13,920
MAKING AROUND THIS. 

2119
01:23:13,920 --> 01:23:15,440
THANK YOU.

2120
01:23:15,440 --> 01:23:18,520
AND I APOLOGIZE FOR MY CANINE

2121
01:23:18,520 --> 01:23:18,840
INTERFERENCE.

2122
01:23:18,840 --> 01:23:19,720
>> THANKS, PEARL.

2123
01:23:19,720 --> 01:23:21,920
LET YOUR DOG KNOW THEY NEED TO

2124
01:23:21,920 --> 01:23:22,760
WAIT UNTIL THE DISCUSSION

2125
01:23:22,760 --> 01:23:23,200
PERIOD.

2126
01:23:23,200 --> 01:23:24,960
WE STILL HAVE ONE MORE

2127
01:23:24,960 --> 01:23:25,320
PRESENTATION.

2128
01:23:25,320 --> 01:23:27,160
>> AND I JUST THREW HER

2129
01:23:27,160 --> 01:23:27,600
OUTSIDE.

2130
01:23:27,600 --> 01:23:31,480
HOPEFULLY THAT WILL STOP IT.

2131
01:23:31,480 --> 01:23:32,080
>> OKAY.

2132
01:23:32,080 --> 01:23:34,040
GREAT, THANK YOU.

2133
01:23:34,040 --> 01:23:39,720
OUR LAST PERSPECTIVE HERE WILL

2134
01:23:39,720 --> 01:23:46,640
BE, NOT THE LEAST, BIOSTATISTICS

2135
01:23:46,640 --> 01:23:46,960
PERSPECTIVE.

2136
01:23:46,960 --> 01:23:48,480
COLLABORATOR, ANDREA COOK WILL

2137
01:23:48,480 --> 01:23:51,240
DISCUSS THESE THINGS.

2138
01:23:51,240 --> 01:23:51,560
HI, ANDREA.

2139
01:23:51,560 --> 01:23:52,840
>> GOOD MORNING.

2140
01:23:52,840 --> 01:23:59,680
IT'S EARLY ON THE WEST COAST.

2141
01:23:59,680 --> 01:24:00,960
I'M COLLABORATORY BIOSTATISTICS,

2142
01:24:00,960 --> 01:24:08,720
ON A DSMB AS WELL, TO GIVE THAT

2143
01:24:08,720 --> 01:24:10,240
PERSPECTIVE OF WHAT WE'RE

2144
01:24:10,240 --> 01:24:13,440
LOOKING AT IN THE COURSE OF A

2145
01:24:13,440 --> 01:24:15,640
PRAGMATIC TRIAL, DESIGN CHOICES,

2146
01:24:15,640 --> 01:24:19,560
STOPPING AND HOW WE TRY TO HELP

2147
01:24:19,560 --> 01:24:21,760
WITH STUDIES PIVOT IF NECESSARY

2148
01:24:21,760 --> 01:24:29,440
GIVEN DATA WE'RE REVIEWING.

2149
01:24:29,440 --> 01:24:32,800
MY EXPERIENCE, PCT, FORMAL

2150
01:24:32,800 --> 01:24:33,480
STOPPING FOR EFFECTIVENESS, I

2151
01:24:33,480 --> 01:24:35,680
HAVE IT MORE IN PHASE 4 TRIALS

2152
01:24:35,680 --> 01:24:38,200
WHERE IT'S MORE CLEAR WHEN YOU

2153
01:24:38,200 --> 01:24:39,920
WOULD STOP.

2154
01:24:39,920 --> 01:24:41,800
PRAGMATIC TRIAL BY DESIGN, USING

2155
01:24:41,800 --> 01:24:47,560
NOT JUST ONE AIM, EFFECTIVE WITH

2156
01:24:47,560 --> 01:24:48,640
TRIALS, BUT REALLY LOOKING AT --

2157
01:24:48,640 --> 01:24:55,560
WE KNOW THE ACTION IS HAPPENING,

2158
01:24:55,560 --> 01:25:00,280
DESIGN IS COMPLICATED, CLUSTER

2159
01:25:00,280 --> 01:25:01,320
CENTER WEDGE, STOPPING EARLY

2160
01:25:01,320 --> 01:25:04,520
MIGHT NOT BE THE RIGHT AIM OF

2161
01:25:04,520 --> 01:25:09,160
THE TRIAL, ALMOST NOT USEFUL FOR

2162
01:25:09,160 --> 01:25:10,560
RESOURCES GIVEN BECAUSE YOU WANT

2163
01:25:10,560 --> 01:25:14,040
TO SEE SUBGROUPS AND SORRY

2164
01:25:14,040 --> 01:25:16,000
THINGS, GENERALIZABILITY OF THE

2165
01:25:16,000 --> 01:25:16,680
INTERVENTION.

2166
01:25:16,680 --> 01:25:18,080
SOMETIMES INTERESTED IN LONGER

2167
01:25:18,080 --> 01:25:23,240
TERM OUTCOMES, MAYBE EFFICACY,

2168
01:25:23,240 --> 01:25:26,080
IT'S HARDER TO STOP FOR

2169
01:25:26,080 --> 01:25:26,520
EFFECTIVENESS.

2170
01:25:26,520 --> 01:25:29,680
HOWEVER, WHAT WE TEND TO LOOK AT

2171
01:25:29,680 --> 01:25:34,120
A LOT IS RECRUITMENT GOALS, SOME

2172
01:25:34,120 --> 01:25:37,800
THINGS THAT OFTEN HOW WELL THEY

2173
01:25:37,800 --> 01:25:39,160
ARE GENERALIZABLE, ANALYZE HOW

2174
01:25:39,160 --> 01:25:42,320
WELL THEY ARE RECRUITING AND

2175
01:25:42,320 --> 01:25:43,720
RETAINING CLUSTERS, HOW WELL

2176
01:25:43,720 --> 01:25:45,400
PARTICIPANTS ARE PARTICIPATING

2177
01:25:45,400 --> 01:25:46,680
IN THOSE GOALS.

2178
01:25:46,680 --> 01:25:48,200
IF THOSE AREN'T TO BE MET A LOT

2179
01:25:48,200 --> 01:25:49,640
OF TIMES WE'LL START WORKING

2180
01:25:49,640 --> 01:25:51,200
WITH YOUR TRIALS AND THIS IS

2181
01:25:51,200 --> 01:25:52,720
STUFF TO THINK ABOUT, REALLY

2182
01:25:52,720 --> 01:25:54,880
ABOUT THEIR ABILITY OF OUTCOME

2183
01:25:54,880 --> 01:25:58,120
AND CONTROL GROUP, SO WHAT'S

2184
01:25:58,120 --> 01:26:02,480
NICE PCTs A LOT OF OUTCOMES

2185
01:26:02,480 --> 01:26:06,720
FROM EHR, YOU CAN PULL OUT AND

2186
01:26:06,720 --> 01:26:10,880
CHECK SAMPLE SIZE ASSUMPTION.

2187
01:26:10,880 --> 01:26:13,080
IN COLLABORATORY, PHASE 1

2188
01:26:13,080 --> 01:26:15,600
THROUGH UG3 PHASES, A TON OF

2189
01:26:15,600 --> 01:26:17,800
WORK USING REAL LIFE DATA,

2190
01:26:17,800 --> 01:26:19,200
SHOULD ALSO DO IT OFTEN IN

2191
01:26:19,200 --> 01:26:22,480
MONITORING OF THE TRIAL.

2192
01:26:22,480 --> 01:26:27,520
IPC IS REALLY IMPORTANT.

2193
01:26:27,520 --> 01:26:30,680
I THAT COULD SHOW EFFECTIVENESS

2194
01:26:30,680 --> 01:26:34,200
IF YOU UNBLIND YOUR RESULTS.

2195
01:26:34,200 --> 01:26:39,480
WE DO MONITOR FOR FUTILITY AND

2196
01:26:39,480 --> 01:26:41,520
WAS THINKING WHEN LISTENING, WE

2197
01:26:41,520 --> 01:26:44,080
DON'T NORMALLY DO IT FORMALLY.

2198
01:26:44,080 --> 01:26:47,960
WE LOOK AT IMPLEMENTATION

2199
01:26:47,960 --> 01:26:49,960
OUTCOMES, ADHERENCE, UPTAKE OF

2200
01:26:49,960 --> 01:26:50,360
INTERVENTION.

2201
01:26:50,360 --> 01:26:54,440
AT ONE TRIAL I'VE BEEN ON WHERE

2202
01:26:54,440 --> 01:26:57,520
REDUCING AND CHANGING BLOOD

2203
01:26:57,520 --> 01:27:02,080
PRESSURE, OUTCOME IS

2204
01:27:02,080 --> 01:27:03,200
CARDIOVASCULAR OUTCOME, WITH

2205
01:27:03,200 --> 01:27:04,400
FUTILITY, BLOOD PRESSURE

2206
01:27:04,400 --> 01:27:07,480
SEPARATIONS, A PROCESS TO GET TO

2207
01:27:07,480 --> 01:27:11,400
THE HARDER OUTCOME, WONDERING IF

2208
01:27:11,400 --> 01:27:12,920
PCTS, MONITOR FOR FUTILITY MORE

2209
01:27:12,920 --> 01:27:14,720
ON THE IMPLEMENTATION SIDE TO

2210
01:27:14,720 --> 01:27:16,760
MAKE SURE UPTAKE IS HAPPENING

2211
01:27:16,760 --> 01:27:19,160
AND MAYBE MORE FORMAL PROCESS OF

2212
01:27:19,160 --> 01:27:21,920
WHAT YOU DO IF YOU'RE NOT SEEING

2213
01:27:21,920 --> 01:27:24,640
UPTAKE, HELP FROM MEMBERS TO

2214
01:27:24,640 --> 01:27:25,800
HAVE MORE FORMAL PROCESSES.

2215
01:27:25,800 --> 01:27:28,680
SOMETIMES IT IS HARD TO MAKE A

2216
01:27:28,680 --> 01:27:31,320
DECISION GIVEN WHAT'S GOING ON,

2217
01:27:31,320 --> 01:27:32,960
A LOT OF INVESTMENT, HOW TO MAKE

2218
01:27:32,960 --> 01:27:35,160
DECISIONS AHEAD OF TIME OR WHEN

2219
01:27:35,160 --> 01:27:37,000
PEOPLE SHOULD PIVOT AND WHAT

2220
01:27:37,000 --> 01:27:37,560
SHOULD HAPPEN.

2221
01:27:37,560 --> 01:27:40,280
I WAS ALSO INVOLVED IN A LOT OF

2222
01:27:40,280 --> 01:27:42,080
TRIALS DURING COVID.

2223
01:27:42,080 --> 01:27:46,280
THAT'S WHERE A LOT OF CHANGE IS

2224
01:27:46,280 --> 01:27:46,880
HAPPENING, UNFORTUNATELY,

2225
01:27:46,880 --> 01:27:48,520
THROUGH THE PANDEMIC AND WE HAD

2226
01:27:48,520 --> 01:27:50,120
TO MAKE DIFFICULT DECISIONS NOT

2227
01:27:50,120 --> 01:27:51,680
NECESSARILY STOPPING BUT SOME

2228
01:27:51,680 --> 01:27:53,240
TRIALS WERE ACTUALLY STOPPED,

2229
01:27:53,240 --> 01:27:54,920
NEW TRIAL WAS RESTARTED BECAUSE

2230
01:27:54,920 --> 01:27:56,840
OF THE INTERVENTION WAS SO

2231
01:27:56,840 --> 01:27:58,480
DIFFERENT WE COULDN'T CALL IT

2232
01:27:58,480 --> 01:27:59,600
THE SAME INTERVENTION.

2233
01:27:59,600 --> 01:28:02,080
THAT I THINK IS THE RIGHT THING

2234
01:28:02,080 --> 01:28:05,480
TO DO THAT AND PIVOTING, IRB

2235
01:28:05,480 --> 01:28:07,440
REVIEW IS REALLY NEW STUDY.

2236
01:28:07,440 --> 01:28:08,840
HOPEFULLY WE DON'T HAVE ANOTHER

2237
01:28:08,840 --> 01:28:10,480
PANDEMIC BUT IF AN INTERVENTION

2238
01:28:10,480 --> 01:28:13,040
DOES MAKE SUCH MAJOR CHANGES

2239
01:28:13,040 --> 01:28:16,200
THAT YOU WOULDN'T REALLY WANT TO

2240
01:28:16,200 --> 01:28:18,720
PULL THAT DATA TOGETHER I DO

2241
01:28:18,720 --> 01:28:21,920
THINK ALMOST TREATING IT AS

2242
01:28:21,920 --> 01:28:24,400
MAYBE A FULL PIVOT OF A NEW

2243
01:28:24,400 --> 01:28:28,160
TRIAL IS SOMETHING TO REFLECT

2244
01:28:28,160 --> 01:28:28,400
ON.

2245
01:28:28,400 --> 01:28:32,800
STATISTICALLY WE OFTEN -- SINCE

2246
01:28:32,800 --> 01:28:33,520
COVID STARTED INTRODUCING

2247
01:28:33,520 --> 01:28:37,360
ESTIMATES OVER TIME TO TRY TO

2248
01:28:37,360 --> 01:28:40,520
CAPTURE THIS IN THE PANDEMIC,

2249
01:28:40,520 --> 01:28:42,400
WITH IMPLICATIONS OF POWER, IF

2250
01:28:42,400 --> 01:28:45,160
YOU CAN'T COMBINE EFFECTS DUE TO

2251
01:28:45,160 --> 01:28:49,280
COVID, THE STUDY IS UNDERPOWERED

2252
01:28:49,280 --> 01:28:50,080
THERE'S IMPLICATIONS FOR BOTH

2253
01:28:50,080 --> 01:28:51,360
AND WE HAD TO THINK ABOUT WHAT

2254
01:28:51,360 --> 01:28:53,480
TO DO WITH THAT INFORMATION,

2255
01:28:53,480 --> 01:28:55,120
POSSIBLY REDESIGN A STUDY AND

2256
01:28:55,120 --> 01:28:58,520
MAKE IT GO LONGER IF THERE'S

2257
01:28:58,520 --> 01:28:59,360
FUNDS OF COURSE AVAILABLE TO

2258
01:28:59,360 --> 01:29:02,960
ANSWER QUESTIONS OF INTEREST.

2259
01:29:02,960 --> 01:29:05,960
IN THE CONTEXT, WE'VE LEARNED A

2260
01:29:05,960 --> 01:29:08,680
LOT IN COVID, WORST CASE

2261
01:29:08,680 --> 01:29:11,200
SCENARIO HOPEFULLY WHAT CAN

2262
01:29:11,200 --> 01:29:12,760
HAPPEN IN TRIALS AND PIVOTING.

2263
01:29:12,760 --> 01:29:15,400
PEOPLE HAVE BEEN GOOD ABOUT

2264
01:29:15,400 --> 01:29:16,240
DOCUMENTING CHANGES, TRYING TO

2265
01:29:16,240 --> 01:29:20,000
WORK WITH THE FUNDER AND DSMB OF

2266
01:29:20,000 --> 01:29:22,080
WHEN THINGS NEED TO FULLY PIVOT

2267
01:29:22,080 --> 01:29:26,880
TO A NEW TRIAL, I THINK THE

2268
01:29:26,880 --> 01:29:29,080
DESIGN CHOICES, I THINK IT'S

2269
01:29:29,080 --> 01:29:31,040
CHALLENGING FOR SEPARATE PIVOTS.

2270
01:29:31,040 --> 01:29:33,440
SO I THINK IF YOU THINK THERE'S

2271
01:29:33,440 --> 01:29:36,520
GOING TO BE A LOT OF ADAPTATION

2272
01:29:36,520 --> 01:29:38,360
AND CHANGES, OTHER MAYBE

2273
01:29:38,360 --> 01:29:39,440
PARALLEL GROUP OF CLUSTER

2274
01:29:39,440 --> 01:29:43,040
RANDOMIZED DESIGN MIGHT BE

2275
01:29:43,040 --> 01:29:47,000
BETTER OUTLET, OTHER DESIGN

2276
01:29:47,000 --> 01:29:50,600
CHOICES, IF THIS THING IS OF

2277
01:29:50,600 --> 01:29:52,880
WORRY, BECAUSE YOU HAVE TIME

2278
01:29:52,880 --> 01:29:53,200
CONFOUNDING.

2279
01:29:53,200 --> 01:29:55,080
STEPPING BACK A LITTLE BIT OF

2280
01:29:55,080 --> 01:29:57,160
DESIGNING YOUR STUDY BEFOREHAND

2281
01:29:57,160 --> 01:29:57,920
TO HANDLE THESE COMPLEXITIES AS

2282
01:29:57,920 --> 01:30:00,240
MUCH AS YOU CAN AND THEN YOU DO

2283
01:30:00,240 --> 01:30:02,200
NEED TO PIVOT OVER TIME BUT

2284
01:30:02,200 --> 01:30:03,720
MAKING SURE YOU'RE ESTIMATING

2285
01:30:03,720 --> 01:30:07,680
SOMETHING THAT IS GOING TO BE

2286
01:30:07,680 --> 01:30:10,320
IMPORTANT TO DESCRIBE THE

2287
01:30:10,320 --> 01:30:11,480
INTERVENTION, AND IF THAT

2288
01:30:11,480 --> 01:30:13,560
ESTIMATE IS CHANGING SO MUCH

2289
01:30:13,560 --> 01:30:16,400
DURING THE COURSE OF THE TIME

2290
01:30:16,400 --> 01:30:17,080
REALLY MULTIPLE INTERVENTIONS

2291
01:30:17,080 --> 01:30:20,440
THAT YOU NEED TO BE TESTING, AND

2292
01:30:20,440 --> 01:30:22,360
REALLY WORKING TO TRY TO GET THE

2293
01:30:22,360 --> 01:30:24,440
RIGHT ESTIMATE GIVEN YOUR

2294
01:30:24,440 --> 01:30:25,640
COMPLEXITY OF INTERVENTION AND

2295
01:30:25,640 --> 01:30:26,960
UPDATE YOUR POWER AND SAMPLE

2296
01:30:26,960 --> 01:30:28,800
SIZE CALCULATION AS WELL.

2297
01:30:28,800 --> 01:30:30,560
THAT HAPPENS A LOT ACTUALLY IN

2298
01:30:30,560 --> 01:30:31,760
THE TRIALS.

2299
01:30:31,760 --> 01:30:35,720
LUCKILY MOST PEOPLE ARE

2300
01:30:35,720 --> 01:30:38,000
CONSERVATIVE WITH POWER.

2301
01:30:38,000 --> 01:30:44,120
I THINK WE OFTEN INFLATE SAMPLE

2302
01:30:44,120 --> 01:30:47,000
SIZE, CONFOUNDING AS WELL,

2303
01:30:47,000 --> 01:30:48,200
SELECTION BIAS IN CLUSTER

2304
01:30:48,200 --> 01:30:49,520
RANDOMIZED TRIALS, NOT AS CLEAR

2305
01:30:49,520 --> 01:30:51,680
HOW TO HANDLE ALL THESE ISSUES

2306
01:30:51,680 --> 01:30:53,680
OF UPDATING SAMPLE SIZE EVERY

2307
01:30:53,680 --> 01:30:55,840
TIME IS REALLY IMPORTANT WHEN

2308
01:30:55,840 --> 01:30:57,040
YOU'RE DOING THIS, NOT JUST

2309
01:30:57,040 --> 01:30:59,040
BASED ON WHAT YOU PLANNED BUT

2310
01:30:59,040 --> 01:31:02,080
BASED ON WHAT YOU'RE DOING AND

2311
01:31:02,080 --> 01:31:02,320
SEEING.

2312
01:31:02,320 --> 01:31:06,280
THAT'S MOSTLY WHAT I WANTED TO

2313
01:31:06,280 --> 01:31:08,920
DESCRIBE, AND HAVE DISCUSSION AS

2314
01:31:08,920 --> 01:31:09,480
A WHOLE GROUP TOGETHER.

2315
01:31:09,480 --> 01:31:14,280
>> THANK YOU SO MUCH,
ANDREA.

2316
01:31:14,280 --> 01:31:15,680
LET'S OPEN UP FOR DISCUSSION.

2317
01:31:15,680 --> 01:31:24,360
I WANT TO BEGIN BY ASKING PRIOR

2318
01:31:24,360 --> 01:31:27,280
PANELISTS HERE WHETHER ANY OF

2319
01:31:27,280 --> 01:31:28,360
THE DISCUSSION CUED ADDITIONAL

2320
01:31:28,360 --> 01:31:29,920
THOUGHTS, THINGS YOU WANT TO

2321
01:31:29,920 --> 01:31:37,120
COMMENT ON, QUESTIONS YOU HAD

2322
01:31:37,120 --> 01:31:37,600
FOR EACH OTHER.

2323
01:31:37,600 --> 01:31:39,480
A LOT OF STUFF WAS PUT ON THE

2324
01:31:39,480 --> 01:31:39,680
TABLE.

2325
01:31:39,680 --> 01:31:41,520
>> THIS IS PEARL.

2326
01:31:41,520 --> 01:31:43,920
I LOVED WHAT ANDREA SAID LOOKING

2327
01:31:43,920 --> 01:31:46,360
AT STEP WEDGE, IF YOU THINK A

2328
01:31:46,360 --> 01:31:52,280
STUDY MAY NEED NIP AND TUCK AND

2329
01:31:52,280 --> 01:31:53,400
ALTERATIONS GOES BACK TO STUDY

2330
01:31:53,400 --> 01:31:54,360
INFORMED DESIGN.

2331
01:31:54,360 --> 01:31:56,880
THANKS FOR BRINGING THAT UP,

2332
01:31:56,880 --> 01:31:57,120
ANDREA.

2333
01:31:57,120 --> 01:31:58,520
>> YEAH, I SECOND THE
AVOID THE

2334
01:31:58,520 --> 01:32:02,360
STEP WEDGE AT ALL COSTS.

2335
01:32:02,360 --> 01:32:05,320
>> I DIDN'T WANT TO SAY
EXACTLY

2336
01:32:05,320 --> 01:32:05,520
THAT.

2337
01:32:05,520 --> 01:32:06,840
>> I DID -- YEAH,
PANDEMIC IN

2338
01:32:06,840 --> 01:32:07,880
THE MIDDLE OF IT.

2339
01:32:07,880 --> 01:32:11,000
IT'S REALLY HARD WHEN YOU HAVE

2340
01:32:11,000 --> 01:32:11,520
COMPLEX INTERVENTIONS THAT

2341
01:32:11,520 --> 01:32:14,800
REQUIRE A LOT OF HUMAN RESOURCES

2342
01:32:14,800 --> 01:32:17,320
TO ROLL OUT.

2343
01:32:17,320 --> 01:32:20,080
WE COULDN'T DO, AND IT HAD TO BE

2344
01:32:20,080 --> 01:32:24,360
A CLUSTER DESIGN, AND TOOK A TON

2345
01:32:24,360 --> 01:32:25,080
OF RESOURCES.

2346
01:32:25,080 --> 01:32:26,640
THERE'S NO WAY TO DO IT AT TOO

2347
01:32:26,640 --> 01:32:28,200
MANY SITES IN REAL TIME N FACT

2348
01:32:28,200 --> 01:32:30,800
REALLY MORE THAN ONE OR TWO.

2349
01:32:30,800 --> 01:32:38,760
SO THAT WAS OUR DIFFICULTY.

2350
01:32:38,760 --> 01:32:41,080
>>ONE THING I'D LIKE TO
ASK KEN

2351
01:32:41,080 --> 01:32:42,520
ABOUT, YOU COMMENT A LOT OF

2352
01:32:42,520 --> 01:32:47,000
THESE TRIALS ARE QUALITY

2353
01:32:47,000 --> 01:32:47,440
IMPROVEMENT.

2354
01:32:47,440 --> 01:32:50,960
I WANTED TO MAKE PEOPLE BE AWARE

2355
01:32:50,960 --> 01:32:52,080
FROM A REGULATORY STANDPOINT,

2356
01:32:52,080 --> 01:32:55,440
QUALITY IMPROVEMENT AND RESEARCH

2357
01:32:55,440 --> 01:32:55,840
ARE DIFFERENT.

2358
01:32:55,840 --> 01:32:56,280
>> YES.

2359
01:32:56,280 --> 01:32:59,240
>> QUALITY IMPROVEMENT
DOES NOT

2360
01:32:59,240 --> 01:33:00,680
FALL UNDER REGULATIONS, WHEREAS

2361
01:33:00,680 --> 01:33:01,880
RESEARCH DOES.

2362
01:33:01,880 --> 01:33:03,320
NIH FUNDS RESEARCH, IT DOESN'T

2363
01:33:03,320 --> 01:33:04,280
FUND QUALITY IMPROVEMENT.

2364
01:33:04,280 --> 01:33:06,480
AT LEAST THAT I'M AWARE OF.

2365
01:33:06,480 --> 01:33:09,360
SO I THINK WHILE A LOT OF THIS

2366
01:33:09,360 --> 01:33:12,240
RESEARCH INVOLVES PROBABLY

2367
01:33:12,240 --> 01:33:15,040
IMPROVING ISSUES, JUST BE

2368
01:33:15,040 --> 01:33:21,800
CAREFUL IF YOU CALL YOUR  STUDYA

2369
01:33:21,800 --> 01:33:24,760
QUALITY IMPROVEMENT STUDY, IF

2370
01:33:24,760 --> 01:33:30,000
YOUR IRB AGREES, THAT GOES DOWN

2371
01:33:30,000 --> 01:33:30,760
A DIFFERENT ROUTE.

2372
01:33:30,760 --> 01:33:33,400
>> QUALITY IMPROVEMENT
LIKE,

2373
01:33:33,400 --> 01:33:36,200
ISN'T THERE A SEPARATE TRIAL FOR

2374
01:33:36,200 --> 01:33:36,800
QUALITY IMPROVEMENT RESEARCH?

2375
01:33:36,800 --> 01:33:39,240
>> AS SOON AS YOU PUT THE
WORD

2376
01:33:39,240 --> 01:33:42,640
"RESEARCH" IN THERE, BUT MOST

2377
01:33:42,640 --> 01:33:47,880
PLACES WILL SAY RESEARCHERS

2378
01:33:47,880 --> 01:33:49,160
CREATE GENERALIZABLE KNOWLEDGE.

2379
01:33:49,160 --> 01:33:49,960
QUALITY IMPROVEMENT, MOST PEOPLE

2380
01:33:49,960 --> 01:33:52,040
SAY IT'S MORE OF A LOCAL THING,

2381
01:33:52,040 --> 01:33:54,440
I'LL IMPROVE WHAT I'M DOING

2382
01:33:54,440 --> 01:33:54,640
HERE.

2383
01:33:54,640 --> 01:33:58,360
WE GO ON TO SAY RESEARCH HAS

2384
01:33:58,360 --> 01:34:00,160
RIGID RULES, HERE IS WHERE YOU

2385
01:34:00,160 --> 01:34:08,200
BRING  PRAGMATIC TRIALS.

2386
01:34:08,200 --> 01:34:12,840
IT STARTS TO BLUR LINE AND

2387
01:34:12,840 --> 01:34:16,080
ASSESSMENT BETWEEN QUALITY

2388
01:34:16,080 --> 01:34:21,360
IMPROVEMENT AND RESEARCH.

2389
01:34:21,360 --> 01:34:23,440
IRBs INTERPRET, I DON'T THINK

2390
01:34:23,440 --> 01:34:28,040
THERE WOULD BE 100% AGREEMENT QI

2391
01:34:28,040 --> 01:34:31,120
AND RESEARCH.

2392
01:34:31,120 --> 01:34:33,360
>> A LOT IS GENERALIZABLE

2393
01:34:33,360 --> 01:34:33,640
RESEARCH.

2394
01:34:33,640 --> 01:34:36,880
IF IT'S NOT, IT'S A LOCAL THING

2395
01:34:36,880 --> 01:34:38,640
TO IMPROVE PATIENT CARE,

2396
01:34:38,640 --> 01:34:39,200
SOMETIMES RETROSPECTIVE, YOU

2397
01:34:39,200 --> 01:34:44,400
HAVE TO GO TO THE IRB AND SAY

2398
01:34:44,400 --> 01:34:44,800
RETROSPECTIVELY.

2399
01:34:44,800 --> 01:34:46,640
>> YOU DON'T HAVE TO DO
THAT

2400
01:34:46,640 --> 01:34:46,840
ANYMORE.

2401
01:34:46,840 --> 01:34:48,600
>>GETTING PUBLISHED IS
NOT A

2402
01:34:48,600 --> 01:34:49,640
TRIGGER FOR IRB REVIEW.

2403
01:34:49,640 --> 01:34:50,840
UNFORTUNATELY, A LOT OF JOURNALS

2404
01:34:50,840 --> 01:34:55,120
WILL SAY WE NEED AN IRB --

2405
01:34:55,120 --> 01:34:55,480
>>OKAY.

2406
01:34:55,480 --> 01:34:56,760
>> OFTENTIMES WE SAY THIS
IS

2407
01:34:56,760 --> 01:34:59,840
SEEN BY THE IRB, DETERMINED TO

2408
01:34:59,840 --> 01:35:04,080
BE QUALITY IMPROVEMENT, NOT

2409
01:35:04,080 --> 01:35:05,440
UNDER THE REGULATIONS.

2410
01:35:05,440 --> 01:35:08,400
PEOPLE TO BE AWARE, IT'S A GRAY

2411
01:35:08,400 --> 01:35:10,920
AREA, PRAGMATIC TRIALS MAKE IT

2412
01:35:10,920 --> 01:35:13,000
EVEN MORE GRAY.

2413
01:35:13,000 --> 01:35:14,080
>> GREAT.

2414
01:35:14,080 --> 01:35:14,320
THANKS.

2415
01:35:14,320 --> 01:35:14,560
CORITA?

2416
01:35:14,560 --> 01:35:16,680
>> I WAS GOING SAY, WELL,
I WAS

2417
01:35:16,680 --> 01:35:18,800
GOING TO ARGUE I MEAN MY TRIAL

2418
01:35:18,800 --> 01:35:20,080
WAS QUALITY IMPROVEMENT AND THE

2419
01:35:20,080 --> 01:35:23,680
NIH FUNDED IT SO MAYBE I'M JUST

2420
01:35:23,680 --> 01:35:28,880
AN EXCEPTION, BUT THERE IS AN

2421
01:35:28,880 --> 01:35:29,720
IMPLEMENTATION STUDY SECTION,

2422
01:35:29,720 --> 01:35:33,000
AND PEOPLE WERE VERY CONFUSED SO

2423
01:35:33,000 --> 01:35:35,000
OUR EVALUATION WAS NOT QUALITY

2424
01:35:35,000 --> 01:35:35,840
IMPROVEMENT.

2425
01:35:35,840 --> 01:35:37,600
SO OUR EVALUATION WAS RESEARCH

2426
01:35:37,600 --> 01:35:41,880
BUT THE INTERVENTION ITSELF WAS

2427
01:35:41,880 --> 01:35:42,960
NOT -- IT WAS QUALITY

2428
01:35:42,960 --> 01:35:43,600
IMPROVEMENT, IT WAS IMPROVING

2429
01:35:43,600 --> 01:35:45,400
THINGS AND DOING THINGS THAT ARE

2430
01:35:45,400 --> 01:35:47,560
ALREADY IN EXISTENCE BUT

2431
01:35:47,560 --> 01:35:52,480
BUNDLING THEM TOGETHER AND SO

2432
01:35:52,480 --> 01:35:55,000
OUR OUTCOMES WERE BY CMS DATA

2433
01:35:55,000 --> 01:35:56,440
ONLY AT NYU WENT THROUGH THE IRB

2434
01:35:56,440 --> 01:35:57,640
THERE BUT DID NOT GO THROUGH THE

2435
01:35:57,640 --> 01:35:59,920
IRB AT ANY OF OUR 33 OTHER

2436
01:35:59,920 --> 01:36:02,640
A.D.s, SO WE HAD A SUBCONTRACT

2437
01:36:02,640 --> 01:36:04,200
DO PAY THEM TO DO QUALITY

2438
01:36:04,200 --> 01:36:05,720
IMPROVEMENT BUT THERE WAS NO

2439
01:36:05,720 --> 01:36:07,360
DATA EXCHANGED.

2440
01:36:07,360 --> 01:36:08,480
PEOPLE WERE COMPLETELY CONFUSED,

2441
01:36:08,480 --> 01:36:09,320
AGREE.

2442
01:36:09,320 --> 01:36:10,640
BUT THERE WAS NO RESEARCH

2443
01:36:10,640 --> 01:36:11,960
HAPPENING AT THE SITES.

2444
01:36:11,960 --> 01:36:15,680
IT WAS QUALITY IMPROVEMENT.

2445
01:36:15,680 --> 01:36:18,520
SO, IT WAS CHALLENGING BUT WE

2446
01:36:18,520 --> 01:36:21,000
DID EVENTUALLY EXPLAIN IT TO

2447
01:36:21,000 --> 01:36:21,280
EVERYBODY.

2448
01:36:21,280 --> 01:36:25,200
AND GOT AROUND, YOU KNOW, A LOT

2449
01:36:25,200 --> 01:36:26,000
OF THAT.

2450
01:36:26,000 --> 01:36:26,240
BUT --

2451
01:36:26,240 --> 01:36:30,880
>> I THINK IT'S A GREAT
TOPIC

2452
01:36:30,880 --> 01:36:32,000
FOR MORE GUIDANCE AND

2453
01:36:32,000 --> 01:36:32,320
CLARIFICATION.

2454
01:36:32,320 --> 01:36:32,680
>> ABSOLUTELY.

2455
01:36:32,680 --> 01:36:35,280
>> GIVEN THE TYPE OF
RESEARCH.

2456
01:36:35,280 --> 01:36:36,880
IT IS DIFFICULT.

2457
01:36:36,880 --> 01:36:39,520
DOING THESE QUALITY IMPROVEMENT

2458
01:36:39,520 --> 01:36:41,520
OR STUDIES, IT'S SO IMPORTANT.

2459
01:36:41,520 --> 01:36:43,920
AND WHEN YOU CAN MAKE

2460
01:36:43,920 --> 01:36:44,800
GENERALIZABLE KNOWLEDGE, WE

2461
01:36:44,800 --> 01:36:47,760
SHOULD BE. 

2462
01:36:47,760 --> 01:36:51,840
ANYWAY, ENOUGH ON THAT.

2463
01:36:51,840 --> 01:36:55,440
>> YEAH, THERE'S NO GRAY
SPACES

2464
01:36:55,440 --> 01:36:57,840
IN THE PCT WORLD.

2465
01:36:57,840 --> 01:37:01,800
OTHER COMMENTS OR QUESTIONS FOR

2466
01:37:01,800 --> 01:37:02,200
ONE ANOTHER?

2467
01:37:02,200 --> 01:37:04,440
>> I WAS -- THIS IS
NATALIA.

2468
01:37:04,440 --> 01:37:07,280
AS I WAS LISTENING TO ANDREA, A

2469
01:37:07,280 --> 01:37:10,120
COUPLE THINGS CAME TO MIND.

2470
01:37:10,120 --> 01:37:14,360
ONE IS AS P.I. RUNNING A TRIAL

2471
01:37:14,360 --> 01:37:16,320
THERE NEEDS TO BE CONSTANT

2472
01:37:16,320 --> 01:37:18,200
MONITORING OF ALL ASPECTS, THAT

2473
01:37:18,200 --> 01:37:22,920
REMINDED ME LISTENING TO ANDREA,

2474
01:37:22,920 --> 01:37:24,560
ALSO REMINDED ME OF HOW HELPFUL

2475
01:37:24,560 --> 01:37:29,800
IS IT TO HAVE THE COLLABORATORY,

2476
01:37:29,800 --> 01:37:31,200
SO THE COLLABORATORY CORE AND,

2477
01:37:31,200 --> 01:37:34,840
YOU KNOW, THE BIOSTATISTICS CORE

2478
01:37:34,840 --> 01:37:38,000
THAT THEY HAVE IN PLACE ALLOWS

2479
01:37:38,000 --> 01:37:40,080
YOU TO THINK BROADLY ABOUT THE

2480
01:37:40,080 --> 01:37:41,160
TOPIC THAT WE'RE JUST TALKING

2481
01:37:41,160 --> 01:37:43,880
ABOUT AND HOW MIGHT WE MONITOR

2482
01:37:43,880 --> 01:37:45,440
THROUGHOUT THE TRIAL AND HOW

2483
01:37:45,440 --> 01:37:49,120
MIGHT WE ACTUALLY DO THAT

2484
01:37:49,120 --> 01:37:54,440
BECAUSE EVERY TRIAL WILL BE

2485
01:37:54,440 --> 01:37:55,120
SLIGHTLY DIFFERENT, JUST WANTED

2486
01:37:55,120 --> 01:38:01,000
TO SAY I APPRECIATE THAT. 

2487
01:38:01,000 --> 01:38:02,640
ONE, THE MONITORING HAPPENS,

2488
01:38:02,640 --> 01:38:04,040
THAT ANDREA WAS TALKING ABOUT I

2489
01:38:04,040 --> 01:38:05,160
MIGHT NOT HAVE THOUGHT ABOUT,

2490
01:38:05,160 --> 01:38:06,680
BUT HAVING A GROUP OF PEOPLE TO

2491
01:38:06,680 --> 01:38:09,840
COME TOGETHER TO THINK IS VERY

2492
01:38:09,840 --> 01:38:13,720
HELPFUL.

2493
01:38:13,720 --> 01:38:15,480
>> OTHER COMMENTS?

2494
01:38:15,480 --> 01:38:20,040
QUESTIONS? 

2495
01:38:20,040 --> 01:38:24,240
BEFORE WE OPEN IT UP, I WAS

2496
01:38:24,240 --> 01:38:26,600
STRUCK AS WELL, YOU KNOW, THE

2497
01:38:26,600 --> 01:38:28,240
DIFFERENT THINGS THAT PEOPLE

2498
01:38:28,240 --> 01:38:29,760
HIGHLIGHTED THAT WILL MAKE IT

2499
01:38:29,760 --> 01:38:33,200
MORE LIKELY THAT YOU'LL BE ABLE

2500
01:38:33,200 --> 01:38:34,720
TO RECEIVE SIGNALS THAT

2501
01:38:34,720 --> 01:38:35,920
SOMETHING MIGHT BE HAPPENING AND

2502
01:38:35,920 --> 01:38:38,880
RESPOND TO THEM IN A WAY THAT

2503
01:38:38,880 --> 01:38:40,960
ALLOWS US A STUDY OR SOME KIND

2504
01:38:40,960 --> 01:38:46,520
OF STUDY TO KEEP GOING FORWARD,

2505
01:38:46,520 --> 01:38:50,040
ANDREA'S COMMENT ABOUT SELECTING

2506
01:38:50,040 --> 01:38:52,240
A DESIGN THAT PERMITS YOU TO

2507
01:38:52,240 --> 01:38:55,120
MONITOR AND RESPOND TO SIGNALS

2508
01:38:55,120 --> 01:39:00,360
WITHOUT REALLY COMPROMISING THE

2509
01:39:00,360 --> 01:39:01,960
ESTIMATES.

2510
01:39:01,960 --> 01:39:02,960
HAVING A MULTI-STAKEHOLDERS

2511
01:39:02,960 --> 01:39:04,160
PANEL IN PLACE TO BE IDENTIFYING

2512
01:39:04,160 --> 01:39:07,800
PLACES TO LOOK AND HELPING

2513
01:39:07,800 --> 01:39:11,720
REACT, THERE ARE OTHER THINGS AS

2514
01:39:11,720 --> 01:39:13,920
WELL. 

2515
01:39:13,920 --> 01:39:16,960
WE'VE GOT A COMMENT FROM -- THAT

2516
01:39:16,960 --> 01:39:17,440
CAME IN.

2517
01:39:17,440 --> 01:39:24,960
WENDY, DO YOU WANT TO RELAY THAT

2518
01:39:24,960 --> 01:39:25,240
QUESTION?

2519
01:39:25,240 --> 01:39:25,720
>> SURE.

2520
01:39:25,720 --> 01:39:27,560
THIS MIGHT BE ADDRESSED TO

2521
01:39:27,560 --> 01:39:29,320
ANDREA, SEEMS TO BE A DESIGN

2522
01:39:29,320 --> 01:39:29,680
QUESTION.

2523
01:39:29,680 --> 01:39:32,400
IT MAY HAVE COME UP FOR SOME

2524
01:39:32,400 --> 01:39:34,040
OTHER INVESTIGATORS AS WELL.

2525
01:39:34,040 --> 01:39:38,400
AND THE QUESTION IS REALLY

2526
01:39:38,400 --> 01:39:39,520
CLUSTER RANDOMIZED TRIALS.

2527
01:39:39,520 --> 01:39:42,280
THE QUESTION IS AS MANY CLINICAL

2528
01:39:42,280 --> 01:39:45,080
PRACTICES ARE NOW HOUSED UNDER

2529
01:39:45,080 --> 01:39:47,520
LARGE GROUPS OR ORGANIZATIONS,

2530
01:39:47,520 --> 01:39:49,600
HAVE YOU ADVISED DEALING WITH

2531
01:39:49,600 --> 01:39:53,160
SEPARATE CLINICAL PRACTICES

2532
01:39:53,160 --> 01:39:55,160
WITHIN ONE ORGANIZATION, I THINK

2533
01:39:55,160 --> 01:39:57,560
TALKING MAYBE ABOUT

2534
01:39:57,560 --> 01:39:59,120
CONTAMINATION ISSUES POTENTIALLY

2535
01:39:59,120 --> 01:40:00,440
HERE, WHERE THE CONTROL

2536
01:40:00,440 --> 01:40:01,960
PRACTICES MAY LEARN ABOUT THE

2537
01:40:01,960 --> 01:40:03,320
INTERVENTION BEING OFFERED AT

2538
01:40:03,320 --> 01:40:05,240
SOME OTHER CLINICAL SITES.

2539
01:40:05,240 --> 01:40:08,880
I THINK WE'VE ALSO BEEN

2540
01:40:08,880 --> 01:40:11,160
CONCERNED WITH PROVIDERS THAT

2541
01:40:11,160 --> 01:40:13,240
MIGHT BE SEEING PATIENTS IN MORE

2542
01:40:13,240 --> 01:40:14,560
THAN ONE CLINIC IS SOMETHING

2543
01:40:14,560 --> 01:40:21,880
THAT HAS COME UP AS WELL, AND SO

2544
01:40:21,880 --> 01:40:23,320
ANY THOUGHTS OR SUGGESTIONS FOR

2545
01:40:23,320 --> 01:40:28,960
HOW TO HANDLE THAT?

2546
01:40:28,960 --> 01:40:32,160
>> WELL, HARD TO HANDLE,

2547
01:40:32,160 --> 01:40:32,400
EXACTLY.

2548
01:40:32,400 --> 01:40:34,560
FOR A LOT -- WHAT I'VE LEARNED

2549
01:40:34,560 --> 01:40:36,040
OVER THE YEARS, WE TYPICALLY

2550
01:40:36,040 --> 01:40:37,520
WORRY ABOUT THIS A LOT

2551
01:40:37,520 --> 01:40:41,560
BEFOREHAND AND THEN WE REALIZE

2552
01:40:41,560 --> 01:40:44,560
IT'S HARD, PROVIDERS ARE REALLY

2553
01:40:44,560 --> 01:40:47,280
BUSY, WHEN WE DOCUMENT POTENTIAL

2554
01:40:47,280 --> 01:40:48,240
FOR CONTAMINATION WE CUE THE

2555
01:40:48,240 --> 01:40:50,440
DESIGN AS A LEVEL YOU CAN,

2556
01:40:50,440 --> 01:40:55,160
THINKING OF MINIMAL

2557
01:40:55,160 --> 01:40:59,720
CONTAMINATION, WE WANT BALANCE,

2558
01:40:59,720 --> 01:41:01,400
YOU WANT STATISTICAL POWER.

2559
01:41:01,400 --> 01:41:03,560
SOMETIMES YOU PROMISE A STEP

2560
01:41:03,560 --> 01:41:04,440
WEDGE, WEIGHTLESS CONTROL, WE'LL

2561
01:41:04,440 --> 01:41:08,040
IMPLEMENT THIS A YEAR OUT OR

2562
01:41:08,040 --> 01:41:09,720
DEPENDING ON THE DESIGN, PROVIDE

2563
01:41:09,720 --> 01:41:12,440
MATERIAL FOR EVERYONE A YEAR

2564
01:41:12,440 --> 01:41:13,160
OUT.

2565
01:41:13,160 --> 01:41:17,000
WE'VE HAD TROUBLE WITH -- HERE

2566
01:41:17,000 --> 01:41:19,000
AT KAISER, WORKING ACROSS

2567
01:41:19,000 --> 01:41:22,240
CLINICS, POTENTIALLY A FORM OF

2568
01:41:22,240 --> 01:41:23,000
CONTAMINATION THERE.

2569
01:41:23,000 --> 01:41:25,960
HASN'T BEEN WHEN WE DOCUMENT,

2570
01:41:25,960 --> 01:41:27,840
HAS NOT BEEN AS BIG OF A DEAL

2571
01:41:27,840 --> 01:41:29,840
BECAUSE OF HOW BUSY PEOPLE ARE

2572
01:41:29,840 --> 01:41:32,120
TO IMPLEMENT THESE INTERVENTIONS

2573
01:41:32,120 --> 01:41:33,960
SO UNLESS THERE'S A LOT OF

2574
01:41:33,960 --> 01:41:38,120
TRAINING, IF YOU THINK IT'S

2575
01:41:38,120 --> 01:41:40,760
REALLY TO IMPLEMENT, WE HAVE TO

2576
01:41:40,760 --> 01:41:43,520
STEP BACK AND THINK HOW MUCH --

2577
01:41:43,520 --> 01:41:49,440
HOW BIG COULD CONTAMINATION BE.

2578
01:41:49,440 --> 01:41:52,000
I THINK NIH COLLABORATORY FROM

2579
01:41:52,000 --> 01:41:53,040
STATISTICIANS TALKING ABOUT

2580
01:41:53,040 --> 01:41:54,600
EFFECT BETWEEN GROUPS, AS LONG

2581
01:41:54,600 --> 01:41:55,920
AS THERE'S SOME SEPARATION OF

2582
01:41:55,920 --> 01:41:57,880
THE EFFECT YOU CAN STILL

2583
01:41:57,880 --> 01:41:58,840
ESTIMATE SOMETHING, DIFFERENCE

2584
01:41:58,840 --> 01:41:59,360
BETWEEN GROUPS, RIGHT?

2585
01:41:59,360 --> 01:42:06,400
AS LONG AS MOST OF IT IS NOT

2586
01:42:06,400 --> 01:42:06,880
CONTAMINATED, APPROACH

2587
01:42:06,880 --> 01:42:09,360
ESTIMATION YOU STILL WOULD HAVE

2588
01:42:09,360 --> 01:42:10,480
POWER FOR.

2589
01:42:10,480 --> 01:42:14,120
IT'S NOT A CLEAR ANSWER.

2590
01:42:14,120 --> 01:42:15,400
IT'S INTERVENTION DEPENDENT.

2591
01:42:15,400 --> 01:42:19,040
YOU HAVE TO DECIDE IF

2592
01:42:19,040 --> 01:42:25,160
CONTAMINATION IS A PROBLEM, A

2593
01:42:25,160 --> 01:42:25,920
FEW PEOPLE OVERALL CONTAMINATION

2594
01:42:25,920 --> 01:42:27,560
WILL NOT BE ADDRESS, HOW HARD TO

2595
01:42:27,560 --> 01:42:31,680
IMPLEMENT LIKE IF THEY NEED MORE

2596
01:42:31,680 --> 01:42:33,600
TRAINING, BUT IF YOU THINK IT'S

2597
01:42:33,600 --> 01:42:36,440
PRETTY EASY TO HAVE THE

2598
01:42:36,440 --> 01:42:42,680
CONTAMINATION I THINK STEP BACK

2599
01:42:42,680 --> 01:42:44,280
AND RCT OR EVEN (INDISCERNIBLE)

2600
01:42:44,280 --> 01:42:47,480
IF YOU HAD TO STEP BACK, IT'S

2601
01:42:47,480 --> 01:42:48,320
MORE OBSERVATIONAL, THE

2602
01:42:48,320 --> 01:42:49,560
INTERVENTION, AT DIFFERENT TIME

2603
01:42:49,560 --> 01:42:49,800
POINTS.

2604
01:42:49,800 --> 01:42:52,120
IT'S NOT A CLEAR ANSWER, SORRY.

2605
01:42:52,120 --> 01:42:55,680
I DON'T KNOW IF OTHERS WANT TO

2606
01:42:55,680 --> 01:42:55,880
SPEAK.

2607
01:42:55,880 --> 01:42:57,760
>> YEAH, SO IT'S NOT A
BLINDED

2608
01:42:57,760 --> 01:42:58,080
STUDY.

2609
01:42:58,080 --> 01:43:02,040
HERE IS ONE AREA, IT'S NOT

2610
01:43:02,040 --> 01:43:03,080
BLINDED, CROSSOVER TO PREFERENCE

2611
01:43:03,080 --> 01:43:04,760
OR FOR WHATEVER REASON.

2612
01:43:04,760 --> 01:43:07,920
YOU CAN TRY TO FIX THIS

2613
01:43:07,920 --> 01:43:09,320
STATISTICALLY BY INCREASING

2614
01:43:09,320 --> 01:43:11,320
SAMPLE SIZE, CHOOSING THE

2615
01:43:11,320 --> 01:43:12,640
DESIGN, STEP WEDGE MAY NOT BE

2616
01:43:12,640 --> 01:43:15,920
THE BEST ONE.

2617
01:43:15,920 --> 01:43:17,240
THE OTHER WAYS, CHARGING PEOPLE

2618
01:43:17,240 --> 01:43:18,800
IN THEIR LANES, RIGHT?

2619
01:43:18,800 --> 01:43:20,960
IF YOU HAVE, SAY, NAVIGATOR WHO

2620
01:43:20,960 --> 01:43:22,400
IS EMBEDDING IN PRACTICE, YOU

2621
01:43:22,400 --> 01:43:24,360
TRY TO KICK THAT NAVIGATOR AWAY

2622
01:43:24,360 --> 01:43:26,360
FROM I GUESS THE PRACTITIONER SO

2623
01:43:26,360 --> 01:43:28,320
THAT DOESN'T CREEP OVER INTO

2624
01:43:28,320 --> 01:43:29,600
THEIR STANDARD OF CARE, AS BEST

2625
01:43:29,600 --> 01:43:30,560
YOU CAN.

2626
01:43:30,560 --> 01:43:32,600
YOU HAVE TO BE CREATIVE TO

2627
01:43:32,600 --> 01:43:33,360
COMPARTMENTALIZE AND KEEP PEOPLE

2628
01:43:33,360 --> 01:43:37,600
IN THEIR LANE AND NOT CROSSING

2629
01:43:37,600 --> 01:43:37,800
OVER.

2630
01:43:37,800 --> 01:43:39,240
>> GREAT.

2631
01:43:39,240 --> 01:43:47,560
THANKS, KEVIN AND ANDREA. 

2632
01:43:47,560 --> 01:43:48,640
OUR COLLABORATORY COLLEAGUE

2633
01:43:48,640 --> 01:43:55,800
STEPHANIE MORONE HAD A QUESTION.

2634
01:43:55,800 --> 01:43:57,920
>> YEAH, THANKS TO THOSE.

2635
01:43:57,920 --> 01:44:00,360
ON THE WEST COAST, YOU REQUIRE

2636
01:44:00,360 --> 01:44:03,160
MORE COFFEE TO GET GOING.

2637
01:44:03,160 --> 01:44:04,960
REALLY INTERESTED, KEVIN, WOULD

2638
01:44:04,960 --> 01:44:07,800
LOVE YOUR THOUGHTS, MAYBE WENDY,

2639
01:44:07,800 --> 01:44:11,200
IF YOU HAVE REFLECTIONS AS WELL,

2640
01:44:11,200 --> 01:44:13,480
THE QUESTION ABOUT WHEN AND WHAT

2641
01:44:13,480 --> 01:44:14,360
CIRCUMSTANCES IT MIGHT BE

2642
01:44:14,360 --> 01:44:17,200
APPROPRIATE TO STOP A TRIAL

2643
01:44:17,200 --> 01:44:24,480
EARLY. 

2644
01:44:24,480 --> 01:44:25,160
FUTILITY OR EFFECTIVENESS,

2645
01:44:25,160 --> 01:44:27,360
THINKING ABOUT HOW THE DECISION

2646
01:44:27,360 --> 01:44:30,200
SHOULD BE APPROPRIATELY MADE,

2647
01:44:30,200 --> 01:44:33,040
CASHING OUT RESPONSIBILITY TO

2648
01:44:33,040 --> 01:44:37,760
SPONSOR VERSUS DSMB.

2649
01:44:37,760 --> 01:44:39,880
IN PRIOR DSMB EXPERIENCE SEEING

2650
01:44:39,880 --> 01:44:41,800
SOME INTEREST, PERHAPS PASS THE

2651
01:44:41,800 --> 01:44:43,440
BUCK, HAVING SOMEONE ELSE MAKE

2652
01:44:43,440 --> 01:44:45,960
THE HARD CALL TO STOP EARLY.

2653
01:44:45,960 --> 01:44:48,600
AND IT STRIKES ME COULD BE EVEN

2654
01:44:48,600 --> 01:44:49,360
MORE CHALLENGING FOR DSMB

2655
01:44:49,360 --> 01:44:52,280
MEMBERS IN THE CONTEXT OF PCT,

2656
01:44:52,280 --> 01:44:56,160
PART OF THE MOTIVATION IS TO

2657
01:44:56,160 --> 01:44:59,520
CHANGE PRACTICE, THE EXTENT TO

2658
01:44:59,520 --> 01:45:01,720
WHICH THE WAY WE COMPRISE

2659
01:45:01,720 --> 01:45:06,760
DSMBs AND EXERCISE, WHETHER

2660
01:45:06,760 --> 01:45:07,520
INDIVIDUALS HAVE INSIGHT WHETHER

2661
01:45:07,520 --> 01:45:10,560
OR NOT THE LEVEL OF EVIDENCE

2662
01:45:10,560 --> 01:45:12,320
WILL BE HIGH ENOUGH TO MOTIVATE

2663
01:45:12,320 --> 01:45:14,400
A HEALTH SIS TOMORROW TO CHANGE

2664
01:45:14,400 --> 01:45:14,680
PRACTICE.

2665
01:45:14,680 --> 01:45:18,600
THERE'S A LOT IN THERE BUT ANY

2666
01:45:18,600 --> 01:45:18,880
REFLECTIONS?

2667
01:45:18,880 --> 01:45:20,120
>> IT'S VERY DIFFICULT.

2668
01:45:20,120 --> 01:45:21,440
IT'S A COMPLEX QUESTION.

2669
01:45:21,440 --> 01:45:24,400
IT'S WHY YOU HAVE A TEAM AND

2670
01:45:24,400 --> 01:45:26,560
IT'S A DSMB.

2671
01:45:26,560 --> 01:45:32,560
IT'S A GROUP DECISION TO MAKE

2672
01:45:32,560 --> 01:45:39,360
AND GO TO GO/NO-GO, STOP TRIAL,

2673
01:45:39,360 --> 01:45:41,360
MAKES IT EVEN MORE DIFFICULT.

2674
01:45:41,360 --> 01:45:43,080
CHANGING THE CULTURE, SAYING

2675
01:45:43,080 --> 01:45:45,080
IT'S OKAY TO FAIL, TO MESS UP,

2676
01:45:45,080 --> 01:45:46,600
ESPECIALLY WHEN YOU HAVE A

2677
01:45:46,600 --> 01:45:48,680
COMPLEX TRIAL, IT'S OKAY TO

2678
01:45:48,680 --> 01:45:49,880
REBOOT AND TO REENGINEER AND

2679
01:45:49,880 --> 01:45:50,640
RESTART.

2680
01:45:50,640 --> 01:45:52,400
AND I THINK THAT DOES TAKE SOME

2681
01:45:52,400 --> 01:45:57,320
OF THE HEAT OFF THE DSMB AND

2682
01:45:57,320 --> 01:45:58,040
INVESTIGATORS THAT, YOU KNOW,

2683
01:45:58,040 --> 01:46:02,560
IT'S NOT THE END OF YOUR TRIAL;

2684
01:46:02,560 --> 01:46:05,720
IT'S PART OF -- IT'S A COMMON

2685
01:46:05,720 --> 01:46:06,320
THEME THAT REENGINEERING IS

2686
01:46:06,320 --> 01:46:09,320
GOING TO HAPPEN.

2687
01:46:09,320 --> 01:46:12,640
THE OTHER THING IS IT'S NOT ONE

2688
01:46:12,640 --> 01:46:13,960
SIGNAL, ONE SAFETY SIGNAL.

2689
01:46:13,960 --> 01:46:17,560
WE LOOK FOR OTHER POINTS, TO

2690
01:46:17,560 --> 01:46:19,440
TRIANGULATE, MAYBE A CAUSAL

2691
01:46:19,440 --> 01:46:21,520
PATHWAY OR ROOT CAUSE THAT LINES

2692
01:46:21,520 --> 01:46:23,000
UP.

2693
01:46:23,000 --> 01:46:25,640
AND I USE THE WORD, THE BURDEN

2694
01:46:25,640 --> 01:46:27,440
OF PROOF IS CLEAR, CONVINCING,

2695
01:46:27,440 --> 01:46:29,280
IS WHAT THEY USE, THE LEGAL

2696
01:46:29,280 --> 01:46:31,120
TERM, YES OR NO, RIGHT?

2697
01:46:31,120 --> 01:46:33,880
IT'S NOT BEYOND REASONABLE

2698
01:46:33,880 --> 01:46:34,080
DOUBT.

2699
01:46:34,080 --> 01:46:35,360
IT'S NOT PREPONDERANCE OF

2700
01:46:35,360 --> 01:46:37,560
EVIDENCE, BUT I THINK CLEAR AND

2701
01:46:37,560 --> 01:46:43,120
CONVINCING IS PROBABLY THE WORD

2702
01:46:43,120 --> 01:46:46,000
I WOULD CHOOSE TO THE LEVEL,

2703
01:46:46,000 --> 01:46:54,840
IT'S A GROUP JUDGMENT CALL.

2704
01:46:54,840 --> 01:46:56,200
>> YEAH, THIS IS WENDY.

2705
01:46:56,200 --> 01:47:01,560
YOU KNOW, I THINK THESE ARE

2706
01:47:01,560 --> 01:47:06,680
REALLY CHALLENGING SITUATIONS.

2707
01:47:06,680 --> 01:47:09,520
AND AT OUR INSTITUTE OR CENTER

2708
01:47:09,520 --> 01:47:13,280
AT NCCIH WE SEE THE DSMB MAKING

2709
01:47:13,280 --> 01:47:16,920
A RECOMMENDATION TO THE DIRECTOR

2710
01:47:16,920 --> 01:47:20,040
OF INSTITUTE OR CENTER, BUT THEY

2711
01:47:20,040 --> 01:47:21,680
ARE SEEING THE DATA, THE MOST

2712
01:47:21,680 --> 01:47:22,040
CLOSELY, RIGHT?

2713
01:47:22,040 --> 01:47:25,520
THEY NEED TO ASK LOTS OF

2714
01:47:25,520 --> 01:47:26,480
QUESTIONS AND, YOU KNOW, I THINK

2715
01:47:26,480 --> 01:47:30,440
THAT IT IS MORE THAN JUST A

2716
01:47:30,440 --> 01:47:32,000
ONE-TIME SIGNAL, THEY ARE OFTEN

2717
01:47:32,000 --> 01:47:33,400
LOOKING FOR A PATTERN IN WHAT

2718
01:47:33,400 --> 01:47:34,040
THEY ARE LOOKING AT.

2719
01:47:34,040 --> 01:47:36,640
MANY OF YOU HAVE SERVED ON

2720
01:47:36,640 --> 01:47:38,000
DSMBs AND HAVE BEEN IN THE

2721
01:47:38,000 --> 01:47:39,200
SITUATION SO IF YOU WANT TO

2722
01:47:39,200 --> 01:47:41,480
SPEAK TO GENERALITYS OF HOW YOU

2723
01:47:41,480 --> 01:47:44,320
SORT OF CONSIDER THAT, THAT'S

2724
01:47:44,320 --> 01:47:45,280
HELPFUL.

2725
01:47:45,280 --> 01:47:48,160
WHAT WE DO AT NCCIH ANYWAY TRY

2726
01:47:48,160 --> 01:47:51,000
TO TAKE THE BURDEN OFF THE DSMB

2727
01:47:51,000 --> 01:47:52,960
AND THEY ARE MAKING A

2728
01:47:52,960 --> 01:47:54,840
RECOMMENDATION THE FINAL

2729
01:47:54,840 --> 01:47:56,680
DECISION DOES COME DOWN TO THE

2730
01:47:56,680 --> 01:47:58,560
INSTITUTE OR CENTER DIRECTOR

2731
01:47:58,560 --> 01:48:01,960
MAKING A DECISION ABOUT IT

2732
01:48:01,960 --> 01:48:03,600
BECAUSE SOMETIMES THERE ARE

2733
01:48:03,600 --> 01:48:06,000
OTHER OUTCOMES THAT WE'RE

2734
01:48:06,000 --> 01:48:08,200
INTERESTED IN, AND WE, YOU KNOW,

2735
01:48:08,200 --> 01:48:10,600
MAY ASK FURTHER FOLLOW-UP

2736
01:48:10,600 --> 01:48:12,120
QUESTIONS OF THE DSMB MEMBERS

2737
01:48:12,120 --> 01:48:18,800
AND WANT TO GET SOME MORE

2738
01:48:18,800 --> 01:48:19,120
INFORMATION.

2739
01:48:19,120 --> 01:48:20,440
YOU KNOW, I THINK ONE OF THE

2740
01:48:20,440 --> 01:48:22,960
THINGS THAT I'VE NOTICED THAT'S

2741
01:48:22,960 --> 01:48:25,800
REALLY DIFFERENT ABOUT PRAGMATIC

2742
01:48:25,800 --> 01:48:28,960
TRIALS IS WE -- IT'S MUCH LESS

2743
01:48:28,960 --> 01:48:33,600
COMMON FOR US TO SEE PLANNED

2744
01:48:33,600 --> 01:48:37,320
ANALYSES OR ASSESSMENT AND

2745
01:48:37,320 --> 01:48:40,280
THRESHOLDS AROUND UPTAKE OR

2746
01:48:40,280 --> 01:48:41,040
INTERVENTION FIDELITY OR THINGS

2747
01:48:41,040 --> 01:48:41,640
LIKE THAT.

2748
01:48:41,640 --> 01:48:44,080
SO IT'S A QUESTION WE'RE

2749
01:48:44,080 --> 01:48:47,480
STARTING TO ASK MORE ABOUT

2750
01:48:47,480 --> 01:48:50,120
SHOULD THE DSMB BE LOOKING AT

2751
01:48:50,120 --> 01:48:51,320
THIS BECAUSE WE'VE SEEN SEVERAL

2752
01:48:51,320 --> 01:48:55,160
TRIALS GET TO THE VERY END AND

2753
01:48:55,160 --> 01:48:56,280
REALIZED THERE PROBABLY WAS A

2754
01:48:56,280 --> 01:48:57,760
SIGNAL EARLIER ON IN THE PROCESS

2755
01:48:57,760 --> 01:49:00,840
THAT WE COULD HAVE CAUGHT.

2756
01:49:00,840 --> 01:49:02,720
AND SHOULD THAT HAVE BEEN

2757
01:49:02,720 --> 01:49:05,120
SOMETHING THAT WE CAUGHT AND

2758
01:49:05,120 --> 01:49:06,320
MAYBE HAD A DISCUSSION AT THAT

2759
01:49:06,320 --> 01:49:07,080
TIME POINT?

2760
01:49:07,080 --> 01:49:10,800
I DON'T KNOW IF OTHERS HAVE

2761
01:49:10,800 --> 01:49:12,000
THOUGHTS OR IDEAS, I'M

2762
01:49:12,000 --> 01:49:16,640
DEFINITELY OPEN TO OTHERS'

2763
01:49:16,640 --> 01:49:16,840
IDEAS.

2764
01:49:16,840 --> 01:49:19,120
>> TISHA WILEY, DO YOU
WANT TO

2765
01:49:19,120 --> 01:49:20,160
MAKE A COMMENT?

2766
01:49:20,160 --> 01:49:25,760
>> I WAS GOING TO ADD OUR

2767
01:49:25,760 --> 01:49:27,760
APPROACH AT NIDA, THE COMPLEXITY

2768
01:49:27,760 --> 01:49:29,160
DEPENDING ON THE INITIATIVE

2769
01:49:29,160 --> 01:49:30,360
WHERE THE INSTITUTE IS MANAGING

2770
01:49:30,360 --> 01:49:33,880
IN HOUSE OR DEFERRING TO DSMB

2771
01:49:33,880 --> 01:49:35,560
THE INVESTIGATOR IS MANAGING,

2772
01:49:35,560 --> 01:49:36,800
AND ACTUALLY THERE'S A LOT OF

2773
01:49:36,800 --> 01:49:39,120
ISSUES ABOUT HOW THE INFORMATION

2774
01:49:39,120 --> 01:49:44,400
GETS REALLY BACK TO PROGRAM,

2775
01:49:44,400 --> 01:49:46,240
WHEN IT'S A DSMB YOU'RE MANAGING

2776
01:49:46,240 --> 01:49:48,160
AS INVESTIGATORS BECAUSE OUR

2777
01:49:48,160 --> 01:49:49,320
SYSTEMS AREN'T SET UP TO REMIND

2778
01:49:49,320 --> 01:49:51,040
TO YOU REGULARLY GIVE US THAT

2779
01:49:51,040 --> 01:49:52,680
INFORMATION.

2780
01:49:52,680 --> 01:49:55,080
IN TERMS OF DSMB WE MANAGE IN

2781
01:49:55,080 --> 01:49:56,680
HOUSE BECAUSE WE'VE GOT REASON

2782
01:49:56,680 --> 01:49:58,400
WHY WE REVIEW A PARTICULAR STUDY

2783
01:49:58,400 --> 01:50:02,280
OR GROUP OF STUDIES AS BEING

2784
01:50:02,280 --> 01:50:04,200
HIGHER IN RISK OR CLOSENESS OF

2785
01:50:04,200 --> 01:50:06,840
US MANAGING, EVEN THEN WE STILL

2786
01:50:06,840 --> 01:50:08,040
VIEW THE DSMB RECOMMENDATION AS

2787
01:50:08,040 --> 01:50:10,000
ONE THAT IS BEING MADE TO THE

2788
01:50:10,000 --> 01:50:12,400
INSTITUTE DIRECTOR AND THAT

2789
01:50:12,400 --> 01:50:15,160
EVERY TIME THE DSMB MEETS

2790
01:50:15,160 --> 01:50:16,480
REREALLY UP THE DSMB'S

2791
01:50:16,480 --> 01:50:18,440
RECOMMENDATIONS TO OUR INSTITUTE

2792
01:50:18,440 --> 01:50:23,680
DIRECTOR TO MAKE SURE THEY ARE

2793
01:50:23,680 --> 01:50:26,320
AWARE. 

2794
01:50:26,320 --> 01:50:28,080
THE TENSIONS, WHETHER THE DSMB

2795
01:50:28,080 --> 01:50:29,080
VIEWS THEMSELVES MAKING A

2796
01:50:29,080 --> 01:50:30,800
DECISION, THE WAY WE OPERATE, WE

2797
01:50:30,800 --> 01:50:32,520
VIEW THEM AS MAKING A

2798
01:50:32,520 --> 01:50:33,960
RECOMMENDATION TO THE INSTITUTE

2799
01:50:33,960 --> 01:50:35,520
DIRECTOR WHO THEN ULTIMATELY

2800
01:50:35,520 --> 01:50:37,640
MAKES THE FINAL DECISION.

2801
01:50:37,640 --> 01:50:39,960
>> THAT'S HOW WE OPERATE
HERE

2802
01:50:39,960 --> 01:50:47,080
AT NIDDK AS WELL.

2803
01:50:47,080 --> 01:50:48,400
>> STEPHANIE, ANY
FOLLOW-UP

2804
01:50:48,400 --> 01:50:49,160
QUESTIONS FROM THAT?

2805
01:50:49,160 --> 01:50:50,920
>>REFLECTIONS ARE
HELPFUL.

2806
01:50:50,920 --> 01:50:53,640
IT DOES MAKE ME WONDER FURTHER

2807
01:50:53,640 --> 01:50:56,040
ABOUT WHO IS SITTING AROUND THAT

2808
01:50:56,040 --> 01:50:58,240
TABLE FOR DSMB, WE MADE

2809
01:50:58,240 --> 01:50:59,040
RECOMMENDATIONS FOR PRAGMATIC

2810
01:50:59,040 --> 01:51:00,440
CLINICAL TRIALS, WANT TO MAKE

2811
01:51:00,440 --> 01:51:04,160
SURE WE HAVE INDIVIDUALS

2812
01:51:04,160 --> 01:51:06,000
FAMILIAR WITH THE

2813
01:51:06,000 --> 01:51:06,560
CONSIDERATIONS.

2814
01:51:06,560 --> 01:51:10,040
WE TALK ABOUT POTENTIALLY

2815
01:51:10,040 --> 01:51:10,880
PATIENTS HAVING MORE IMPORTANT

2816
01:51:10,880 --> 01:51:12,800
VOICE, I DON'T KNOW THE EXTENT.

2817
01:51:12,800 --> 01:51:14,000
I WONDER IF HEALTH SYSTEM

2818
01:51:14,000 --> 01:51:16,080
LEADERS OR OTHERS MIGHT BE

2819
01:51:16,080 --> 01:51:19,600
ANOTHER PERSPECTIVE, IF THAT'S

2820
01:51:19,600 --> 01:51:20,120
THE GROUP.

2821
01:51:20,120 --> 01:51:22,840
ARGUABLY ONE OF THE KEY GROUPS

2822
01:51:22,840 --> 01:51:24,200
WE'RE TRYING TO INFLUENCE WITH

2823
01:51:24,200 --> 01:51:27,680
THESE TRIALS BUT I HAVE

2824
01:51:27,680 --> 01:51:33,120
DISCOMFORT, MY OWN EXPERIENCE

2825
01:51:33,120 --> 01:51:36,960
WITH DSMB, INCLUDE TO

2826
01:51:36,960 --> 01:51:37,840
OVEREMPHASIZE WITH THE

2827
01:51:37,840 --> 01:51:39,800
INVESTIGATORS, IF THE TRIAL GETS

2828
01:51:39,800 --> 01:51:40,920
STOPPED IT MAY HAVE

2829
01:51:40,920 --> 01:51:41,800
IMPLICATIONS, RATHER THAN THE

2830
01:51:41,800 --> 01:51:44,120
PATIENTS FOR WHOM WE MIGHT BE

2831
01:51:44,120 --> 01:51:48,920
CONTINUING TO BURDEN EVEN IF THE

2832
01:51:48,920 --> 01:51:50,640
RISK IS LOW AND CERTAINLY

2833
01:51:50,640 --> 01:51:52,160
CHALLENGES WITH THAT STRUCTURE,

2834
01:51:52,160 --> 01:51:55,160
SOMEONE WHO SIMILARLY IS

2835
01:51:55,160 --> 01:51:55,880
DEPENDENT ON FUNDING STRUCTURE,

2836
01:51:55,880 --> 01:51:58,800
BUT MAYBE ONE OF THE

2837
01:51:58,800 --> 01:52:01,400
REFLECTIONS, KEVIN CHAN,

2838
01:52:01,400 --> 01:52:02,120
APPRECIATING YOUR REFLECTIONS,

2839
01:52:02,120 --> 01:52:06,240
THAT IT SHOULD BE AN EXPECTATION

2840
01:52:06,240 --> 01:52:07,520
THAT SOME WILL REQUIRE TO FAIL

2841
01:52:07,520 --> 01:52:11,040
AND PIVOT AND HAVE A DIFFERENT

2842
01:52:11,040 --> 01:52:15,080
OFF-RAMP, MORE COMFORT MAKING

2843
01:52:15,080 --> 01:52:15,520
THE CALL.

2844
01:52:15,520 --> 01:52:20,120
>> PEARL CAN COMMENT
MORE.

2845
01:52:20,120 --> 01:52:26,360
LOOKING AT FROM  ETHICAL LENS,

2846
01:52:26,360 --> 01:52:26,960
STATISTICAL LENS, OPERATIONAL

2847
01:52:26,960 --> 01:52:28,000
LENS, RIGHT?

2848
01:52:28,000 --> 01:52:32,600
YOU CAN LOOK AT PATIENTS,

2849
01:52:32,600 --> 01:52:34,080
MANAGING POPULATIONS, NOT

2850
01:52:34,080 --> 01:52:35,760
INDIVIDUALS, AFFECTS

2851
01:52:35,760 --> 01:52:41,320
INDIVIDUALS, THE AIM.

2852
01:52:41,320 --> 01:52:44,920
BUT ETHICISTS HELP US FRAME

2853
01:52:44,920 --> 01:52:46,600
THINGS, ETHICALLY IS TO PUT

2854
01:52:46,600 --> 01:52:48,960
PATIENTS AND PROVIDERS THROUGH

2855
01:52:48,960 --> 01:52:50,640
THIS ACTIVITY, GIVEN THE CHANCES

2856
01:52:50,640 --> 01:52:53,560
OF SUCCESS OR FAILURE OF THIS

2857
01:52:53,560 --> 01:52:53,760
TRIAL.

2858
01:52:53,760 --> 01:52:57,200
>> I THINK THAT'S A GOOD
POINT.

2859
01:52:57,200 --> 01:52:58,840
THE DSMB JOB IS A LOT EASIER

2860
01:52:58,840 --> 01:53:00,720
WHEN IT'S A SAFETY ISSUE.

2861
01:53:00,720 --> 01:53:01,800
I MEAN, THAT'S EASIER TO GET

2862
01:53:01,800 --> 01:53:04,080
YOUR ARMS AROUND.

2863
01:53:04,080 --> 01:53:06,720
WHEN IT'S MORE FUTILITY ISSUE,

2864
01:53:06,720 --> 01:53:08,880
YOU KNOW, WHAT'S THE RISK OF THE

2865
01:53:08,880 --> 01:53:10,640
RESEARCH, WHAT ARE YOU EXPECTING

2866
01:53:10,640 --> 01:53:11,920
PARTICIPANTS TO DO?

2867
01:53:11,920 --> 01:53:14,720
AND THEN YOU GET IN THERE MIGHT

2868
01:53:14,720 --> 01:53:17,040
BE SECONDARY AIMS, THAT'S A MUCH

2869
01:53:17,040 --> 01:53:18,760
MUDDIER WATER.

2870
01:53:18,760 --> 01:53:23,120
BUT I THINK PURELY -- I HANG OUT

2871
01:53:23,120 --> 01:53:29,280
WITH BIOETHICISTS, I'M NOT A

2872
01:53:29,280 --> 01:53:29,600
BIOETHICISTS.

2873
01:53:29,600 --> 01:53:31,120
IF THE RESEARCH IS NOT GOING

2874
01:53:31,120 --> 01:53:32,960
FORWARD IN A MEANINGFUL WAY THEN

2875
01:53:32,960 --> 01:53:34,200
ANY RISK IS NOT WORTH PUTTING

2876
01:53:34,200 --> 01:53:35,600
SOMEONE THROUGH BUT IT'S MAKING

2877
01:53:35,600 --> 01:53:37,160
THAT DECISION OF IT'S NOT GOING

2878
01:53:37,160 --> 01:53:43,240
TO GO FORWARD IN ANY WAY IS THE

2879
01:53:43,240 --> 01:53:44,360
DIFFICULT PART.

2880
01:53:44,360 --> 01:53:46,040
>> PEARL, YOU'RE GIVING
US

2881
01:53:46,040 --> 01:53:47,000
PERMISSION TO SAY THAT.

2882
01:53:47,000 --> 01:53:49,000
SOMETIMES WE NEED SOMEONE TO BE

2883
01:53:49,000 --> 01:53:50,080
ABLE TO DO THAT.

2884
01:53:50,080 --> 01:53:51,120
YOU'RE IN THE ROOM.

2885
01:53:51,120 --> 01:53:51,400
>> YEAH.

2886
01:53:51,400 --> 01:53:53,360
>> BECAUSE IT'S NOT EASY
TO BE

2887
01:53:53,360 --> 01:53:57,000
THE FIRST ONE UP AND SAY NO.

2888
01:53:57,000 --> 01:53:59,120
>> WHY ARE WE DOING THIS,

2889
01:53:59,120 --> 01:53:59,560
EXACTLY.

2890
01:53:59,560 --> 01:54:01,120
>> THIS IS REMINDING ME
OF

2891
01:54:01,120 --> 01:54:03,760
SOMETHING THAT CHERYL SAID IN

2892
01:54:03,760 --> 01:54:05,160
HER PRESENTATION.

2893
01:54:05,160 --> 01:54:08,880
CHERYL, YOU MADE A NOTE THE

2894
01:54:08,880 --> 01:54:10,520
DECISION TO STOP OR MASSIVELY

2895
01:54:10,520 --> 01:54:13,920
CHANGE A STUDY IS A PROFOUND ONE

2896
01:54:13,920 --> 01:54:14,880
THAT SHOULD INCLUDE PATIENTS IN

2897
01:54:14,880 --> 01:54:15,800
THE COMMUNITY.

2898
01:54:15,800 --> 01:54:18,400
DO YOU WANT TO SAY A LITTLE BIT

2899
01:54:18,400 --> 01:54:19,720
MORE ABOUT KIND OF WHAT YOUR

2900
01:54:19,720 --> 01:54:22,680
THINKING IS AS REGARDS THIS

2901
01:54:22,680 --> 01:54:24,960
CONVERSATION, WHAT TYPE OF INPUT

2902
01:54:24,960 --> 01:54:28,080
MIGHT BE NEEDED AND WHY IT'S

2903
01:54:28,080 --> 01:54:28,960
IMPORTANT?

2904
01:54:28,960 --> 01:54:34,200
I THINK YOU'RE MUTED, CHERYL.

2905
01:54:34,200 --> 01:54:35,960
OR YOU'VE GOT SOME AUDIO ISSUE

2906
01:54:35,960 --> 01:54:36,160
THERE.

2907
01:54:36,160 --> 01:54:37,160
>> THERE YOU GO.

2908
01:54:37,160 --> 01:54:38,440
CAN YOU HEAR ME?

2909
01:54:38,440 --> 01:54:39,000
>>YEP, YEP.

2910
01:54:39,000 --> 01:54:40,920
>> SORRY ABOUT THAT.

2911
01:54:40,920 --> 01:54:43,200
WELL, I THINK NUMBER ONE, WE DO

2912
01:54:43,200 --> 01:54:47,440
HAVE SOME THAT ARE INVOLVED IN

2913
01:54:47,440 --> 01:54:49,000
TERMS OF IRBs, BUT IT'S

2914
01:54:49,000 --> 01:54:52,600
THINKING ABOUT IS IT REALLY

2915
01:54:52,600 --> 01:54:54,800
NECESSARY TO HAVE AN ACTUAL

2916
01:54:54,800 --> 01:54:55,880
DELIBERATE COMMUNITY REVIEW OR

2917
01:54:55,880 --> 01:54:57,040
PATIENT REVIEW WHEN WE'RE AT

2918
01:54:57,040 --> 01:54:59,600
THAT POINT BECAUSE OF THE

2919
01:54:59,600 --> 01:55:02,000
IMPLICATIONS BECAUSE YOU ARE

2920
01:55:02,000 --> 01:55:04,120
REALLY MAYBE DEIMPLEMENTING

2921
01:55:04,120 --> 01:55:08,360
SOMETHING THAT HAS AN IMPACT OR

2922
01:55:08,360 --> 01:55:11,960
BE LEAVING A VOID IN TERMS OF

2923
01:55:11,960 --> 01:55:14,160
SOME PART OF PRACTICE OR WHAT

2924
01:55:14,160 --> 01:55:17,000
THAT MIGHT MEAN IN TERMS OF THE

2925
01:55:17,000 --> 01:55:17,400
COMMUNITY.

2926
01:55:17,400 --> 01:55:20,760
AND I THINK THAT WE CAN

2927
01:55:20,760 --> 01:55:22,680
STRENGTHEN THAT, BESIDES OUR

2928
01:55:22,680 --> 01:55:23,760
REGULAR REPRESENTATIVES FROM IRB

2929
01:55:23,760 --> 01:55:27,960
AND THINK ABOUT WHETHER OR NOT

2930
01:55:27,960 --> 01:55:29,680
SOMETHING AS IMPACTFUL AS THAT

2931
01:55:29,680 --> 01:55:31,040
REQUIRES ADDITIONAL BODY IN

2932
01:55:31,040 --> 01:55:32,520
TERMS OF COMMUNITY REVIEW BOARD

2933
01:55:32,520 --> 01:55:34,320
OR PATIENT REVIEW BOARD WHEN

2934
01:55:34,320 --> 01:55:36,520
WE'RE GOING TO DO SUCH AN

2935
01:55:36,520 --> 01:55:38,040
ACTION, BE AN ADDITION TO WHAT

2936
01:55:38,040 --> 01:55:39,920
WE TYPICALLY DO.

2937
01:55:39,920 --> 01:55:46,680
AND WE'RE REALLY DOING, WHEN

2938
01:55:46,680 --> 01:55:50,720
WE'RE STOPPING A STUDY WE'RE

2939
01:55:50,720 --> 01:55:51,200
DEIMPLEMENTING.

2940
01:55:51,200 --> 01:55:52,000
DEIMPLEMENTATION IS SOMETHING

2941
01:55:52,000 --> 01:55:53,560
THAT WE REALLY STILL DON'T TALK

2942
01:55:53,560 --> 01:55:56,800
A LOT ABOUT AND KNOW A LOT

2943
01:55:56,800 --> 01:55:59,880
ABOUT, AND IT IS A DIFFERENT

2944
01:55:59,880 --> 01:56:01,440
ACTION THAT HAS -- CAN HAVE

2945
01:56:01,440 --> 01:56:03,520
CONSEQUENCES IN TERMS OF ETHICS,

2946
01:56:03,520 --> 01:56:05,840
AND AS WELL AS OUR RELATIONSHIP

2947
01:56:05,840 --> 01:56:07,240
WITH PATIENTS AND COMMUNITY, IF

2948
01:56:07,240 --> 01:56:13,680
WE'RE GOING TO CONTINUE TO DO

2949
01:56:13,680 --> 01:56:14,720
PRAGMATIC TRIALS.

2950
01:56:14,720 --> 01:56:16,960
>> THANK YOU, CHERYL.

2951
01:56:16,960 --> 01:56:20,000
IS THERE ANYTHING THAT WE

2952
01:56:20,000 --> 01:56:22,440
HAVEN'T ADDRESSED YET ABOUT WAYS

2953
01:56:22,440 --> 01:56:24,200
TO INCREASE OPPORTUNITIES FOR

2954
01:56:24,200 --> 01:56:26,600
EARLY LEARNING, FOR GETTING

2955
01:56:26,600 --> 01:56:30,320
EARLY SIGNALS, AND HOW BEST TO

2956
01:56:30,320 --> 01:56:32,280
PROCESS THOSE EARLY SIGNALS TO

2957
01:56:32,280 --> 01:56:33,840
INFORM DECISIONS ABOUT WHAT

2958
01:56:33,840 --> 01:56:34,600
HAPPENS NEXT?

2959
01:56:34,600 --> 01:56:36,000
ARE THERE ANY OTHER

2960
01:56:36,000 --> 01:56:38,280
CONSIDERATIONS THAT WE HAVEN'T

2961
01:56:38,280 --> 01:56:38,920
RAISED YET?

2962
01:56:38,920 --> 01:56:42,520
>> I DID MENTION BEFORE
THE

2963
01:56:42,520 --> 01:56:43,920
ROLE OF QUALITATIVE RESEARCH.

2964
01:56:43,920 --> 01:56:46,760
AND THAT'S IMPORTANT IN TERMS OF

2965
01:56:46,760 --> 01:56:48,960
CONTEXT AND IN UNDERSTANDING

2966
01:56:48,960 --> 01:56:52,800
SOME OF THE DATA BECAUSE

2967
01:56:52,800 --> 01:56:55,200
ADDITIONAL MULTI-MODES OF DATA

2968
01:56:55,200 --> 01:56:56,400
INCLUDING QUALITATIVE RESERVE

2969
01:56:56,400 --> 01:56:58,840
ALONG THE PROCESS AND ANALYZING

2970
01:56:58,840 --> 01:57:04,400
THAT AS WELL AS PART OF AN EARLY

2971
01:57:04,400 --> 01:57:05,600
DECISION REALLY INFORMS CHOICES.

2972
01:57:05,600 --> 01:57:07,560
AND REALLY MAY GIVE SOME BETTER

2973
01:57:07,560 --> 01:57:08,760
UNDERSTANDING, AND THAT'S NOT

2974
01:57:08,760 --> 01:57:11,480
ALWAYS A COMPONENT OF HOW WE

2975
01:57:11,480 --> 01:57:11,840
PROCEED.

2976
01:57:11,840 --> 01:57:13,920
IT MAY BE THAT WE HAVE IT AT THE

2977
01:57:13,920 --> 01:57:15,960
BEGINNING WHEN WE'RE DESIGNING,

2978
01:57:15,960 --> 01:57:18,920
BUT TO CONTINUE TO INVOLVE

2979
01:57:18,920 --> 01:57:20,640
QUALITATIVE METHODS AND HOW WE

2980
01:57:20,640 --> 01:57:23,760
LOOK AT DATA I THINK IS

2981
01:57:23,760 --> 01:57:24,160
IMPORTANT.

2982
01:57:24,160 --> 01:57:28,360
>> THAT'S A GREAT POINT.

2983
01:57:28,360 --> 01:57:31,200
I THINK NATALIA MADE A SIMILAR

2984
01:57:31,200 --> 01:57:32,320
POINT WHEN THEY WERE CONSIDERING

2985
01:57:32,320 --> 01:57:37,440
HOW TO ADAPT THE INTERVENTION

2986
01:57:37,440 --> 01:57:38,760
AFTER COVID HIT, A GOOD

2987
01:57:38,760 --> 01:57:41,920
REMINDER, IT'S A TOOL IT COULD

2988
01:57:41,920 --> 01:57:44,680
BE USED THROUGHOUT TO PROVIDE

2989
01:57:44,680 --> 01:57:46,200
VALUABLE INFORMATION.

2990
01:57:46,200 --> 01:57:47,520
>> CAN THE
BIOSTATISTICIANS

2991
01:57:47,520 --> 01:57:48,600
PROVIDE SOME DEGREE OF

2992
01:57:48,600 --> 01:57:50,120
CONFIDENCE BEHIND?

2993
01:57:50,120 --> 01:57:51,880
WHEN DECISIONS ARE MADE, THERE'S

2994
01:57:51,880 --> 01:57:53,560
USUALLY NOT -- P-VALUE IS NOT

2995
01:57:53,560 --> 01:57:54,280
THERE, RIGHT?

2996
01:57:54,280 --> 01:57:56,480
IT'S A LOT OF THESE NUMBERS ARE

2997
01:57:56,480 --> 01:57:58,160
MOVING AND LINING UP, RIGHT?

2998
01:57:58,160 --> 01:58:01,760
IS THERE A WAY YOU CAN SAY

2999
01:58:01,760 --> 01:58:03,160
THERE'S A 95% OR 80% CHANCE IF

3000
01:58:03,160 --> 01:58:07,320
WE KEEP DOING THIS, THIS IS

3001
01:58:07,320 --> 01:58:09,840
WHAT'S GOING TO HAPPEN?

3002
01:58:09,840 --> 01:58:11,360
>> CONDITIONAL POWER,
FUTILITY

3003
01:58:11,360 --> 01:58:12,360
BOUNDARY FORMAL, DEPENDS ON WHAT

3004
01:58:12,360 --> 01:58:13,040
YOU WANT TO ESTIMATE.

3005
01:58:13,040 --> 01:58:18,680
IF YOU WANT TO ESTIMATE BASED ON

3006
01:58:18,680 --> 01:58:19,520
PRIMARY OUTCOME, IT'S BEEN

3007
01:58:19,520 --> 01:58:21,480
AROUND FOR A LONG TIME FOR

3008
01:58:21,480 --> 01:58:23,400
REGULAR RCTs.

3009
01:58:23,400 --> 01:58:27,920
I THINK IF YOU'RE MORE CONCERNED

3010
01:58:27,920 --> 01:58:29,760
ABOUT HETEROGENEITY AND

3011
01:58:29,760 --> 01:58:34,400
VARIABILITY, THAT'S WHERE YOU

3012
01:58:34,400 --> 01:58:35,200
HAVE TROUBLE.

3013
01:58:35,200 --> 01:58:39,760
ESTIMATING THE  THE SAME EFFECTE

3014
01:58:39,760 --> 01:58:41,840
NEXT YEAR WITH INTERVENTION

3015
01:58:41,840 --> 01:58:43,160
ADAPTS, IT'S EASIER WORKING WITH

3016
01:58:43,160 --> 01:58:45,240
A FEW DRUGS, IT'S NOT GOING TO

3017
01:58:45,240 --> 01:58:47,080
CHANGE, MAYBE THE POPULATION

3018
01:58:47,080 --> 01:58:47,960
YOU'RE RANDOMIZING TO CHANGES

3019
01:58:47,960 --> 01:58:49,600
BUT NOW YOU HAVE INTERVENTION

3020
01:58:49,600 --> 01:58:52,560
THAT'S DYNAMIC THAT MAY BE

3021
01:58:52,560 --> 01:58:53,440
IMPROVING OVER TIME, EARLY

3022
01:58:53,440 --> 01:58:55,520
EFFECT AT INTERVENTION MAY NOT

3023
01:58:55,520 --> 01:59:00,560
BE THE EFFECT AFTER YOU ADAPT IT

3024
01:59:00,560 --> 01:59:02,960
FOUR MONTHS FROM NOW.

3025
01:59:02,960 --> 01:59:04,160
YOUR ESTIMATE OF INTEREST

3026
01:59:04,160 --> 01:59:10,080
CHANGES, BUT YOU DO HAVE

3027
01:59:10,080 --> 01:59:13,040
CONDITIONAL POWER, FUTILITY

3028
01:59:13,040 --> 01:59:13,680
BOUNDARIES, SAFETY BOUNDARIES

3029
01:59:13,680 --> 01:59:15,840
FOR CLINICAL TRIALS, WORRIED

3030
01:59:15,840 --> 01:59:18,880
ABOUT SAFETY RISK.

3031
01:59:18,880 --> 01:59:20,240
THERE IS STATISTICS, IT'S THAT

3032
01:59:20,240 --> 01:59:21,880
ESTIMATE, WHAT YOU THINK WILL

3033
01:59:21,880 --> 01:59:23,480
CHANGE OVER TIME SO TO GET US TO

3034
01:59:23,480 --> 01:59:27,240
BE ABLE TO GET TO THAT ESTIMATE

3035
01:59:27,240 --> 01:59:29,760
THAT YOU NEED, TO SAY

3036
01:59:29,760 --> 01:59:30,120
EFFECTIVENESS.

3037
01:59:30,120 --> 01:59:32,840
FUTILITY YOU DO ON

3038
01:59:32,840 --> 01:59:33,520
IMPLEMENTATION OUTCOMES,

3039
01:59:33,520 --> 01:59:33,920
DEFINITELY.

3040
01:59:33,920 --> 01:59:36,000
IF YOU THINK THERE'S A PATHWAY

3041
01:59:36,000 --> 01:59:37,400
FOR YOUR STUDY FROM

3042
01:59:37,400 --> 01:59:39,080
IMPLEMENTATION TO GET THAT

3043
01:59:39,080 --> 01:59:40,960
EFFECTIVENESS OUTCOME AND YOU'RE

3044
01:59:40,960 --> 01:59:47,040
NOT SEEING UPTAKE OR SEEING

3045
01:59:47,040 --> 01:59:50,800
ASPECTS THOSE ARE WHERE WE CAN

3046
01:59:50,800 --> 01:59:59,560
PUT BOUND REIS -- BOUNDARIES.

3047
01:59:59,560 --> 02:00:01,160
WHICH ONE YOU WANT TO ESTIMATE,

3048
02:00:01,160 --> 02:00:02,480
IT'S HARD.

3049
02:00:02,480 --> 02:00:05,080
>> SO I WOULD SAY WITH

3050
02:00:05,080 --> 02:00:07,120
DIFFERENTIAL WITHDRAWAL IS ONE

3051
02:00:07,120 --> 02:00:09,080
GROUP, OR TABLE 1, DIFFERENCE OF

3052
02:00:09,080 --> 02:00:10,840
AGE OF, SAY, FIVE YEARS BETWEEN

3053
02:00:10,840 --> 02:00:12,680
THE TWO GROUPS, SO THAT'S A

3054
02:00:12,680 --> 02:00:16,080
LARGE DIFFERENCE, RIGHT?

3055
02:00:16,080 --> 02:00:17,040
SUGGESTING NONRANDOM BIAS.

3056
02:00:17,040 --> 02:00:18,800
WHAT'S IT GOING TO TAKE TO

3057
02:00:18,800 --> 02:00:21,640
BALANCE THINGS OUT, IS THERE A

3058
02:00:21,640 --> 02:00:26,880
WAY TO SAY THERE'S A 95% CHANCE

3059
02:00:26,880 --> 02:00:32,280
THE TRIAL WILL END UP IN BALANCE

3060
02:00:32,280 --> 02:00:33,360
AND BIAS?

3061
02:00:33,360 --> 02:00:35,560
>> WITHDRAWAL, NOT JUST

3062
02:00:35,560 --> 02:00:36,080
INTERVENTION WITHDRAWAL.

3063
02:00:36,080 --> 02:00:38,520
>> YES, INTERVENTION IS

3064
02:00:38,520 --> 02:00:41,800
BURDENSOME SO PEOPLE WITHDRAW AT

3065
02:00:41,800 --> 02:00:44,760
INTERVENTION SITE, OR TABLE 1,

3066
02:00:44,760 --> 02:00:51,400
THERE'S PREFERENCE IN ENROLLING

3067
02:00:51,400 --> 02:00:55,680
PATIENTS, DIFFERENCE IN TABLE 1,

3068
02:00:55,680 --> 02:00:57,240
THAT RANDOMIZATION OF CLUSTERS.

3069
02:00:57,240 --> 02:00:59,040
>> I THINK PULLING WORK
FROM

3070
02:00:59,040 --> 02:01:01,600
ALTERATION TRIALS, SELECTION

3071
02:01:01,600 --> 02:01:03,280
BIAS, MISSING DATA OUTCOMES,

3072
02:01:03,280 --> 02:01:04,680
QUANTIFY FROM OBSERVATIONAL

3073
02:01:04,680 --> 02:01:04,880
TRIALS.

3074
02:01:04,880 --> 02:01:08,360
THAT'S WHAT I THINK OF THE PCT,

3075
02:01:08,360 --> 02:01:09,920
IN BETWEEN A CONTROLLED

3076
02:01:09,920 --> 02:01:11,240
RANDOMIZED TRIAL, IMPROVING WHAT

3077
02:01:11,240 --> 02:01:12,760
YOU CAN FROM OBSERVATIONAL

3078
02:01:12,760 --> 02:01:17,040
TRIAL, SOME ESTIMATES OF THE

3079
02:01:17,040 --> 02:01:20,800
BIAS, WITH PEOPLE BEING

3080
02:01:20,800 --> 02:01:22,560
COLLECTED IN POPULATION, TO LIKE

3081
02:01:22,560 --> 02:01:26,480
MISSING DATA BIAS, WORKING WITH

3082
02:01:26,480 --> 02:01:29,640
OUTCOME DATA.

3083
02:01:29,640 --> 02:01:32,200
ADHERENCE ALSO, IF YOU ESTIMATE

3084
02:01:32,200 --> 02:01:34,720
BASED ON ADHERENCE PATTERNS,

3085
02:01:34,720 --> 02:01:38,680
THERE'S METHODS TO LOOK AT -- I

3086
02:01:38,680 --> 02:01:40,960
CAN'T REMEMBER THE STATISTIC TO

3087
02:01:40,960 --> 02:01:43,400
ESTIMATE CONFOUNDING POTENTIAL.

3088
02:01:43,400 --> 02:01:45,200
IT DOES HELP WITH DATA, WHAT

3089
02:01:45,200 --> 02:01:46,440
PEOPLE HAVE, IF YOU THINK IT'S

3090
02:01:46,440 --> 02:01:49,760
GOING TO CONTINUE THROUGHOUT THE

3091
02:01:49,760 --> 02:01:49,960
STUDY.

3092
02:01:49,960 --> 02:01:55,360
YOU COULD PUT A BAN ON WHAT YOU

3093
02:01:55,360 --> 02:01:56,880
CAN ESTIMATE, THAT'S WHERE IT

3094
02:01:56,880 --> 02:02:03,640
GETS TRICKY TO MAKE THE

3095
02:02:03,640 --> 02:02:03,920
DECISIONS.

3096
02:02:03,920 --> 02:02:05,200
>> THANKS, ANDREA.

3097
02:02:05,200 --> 02:02:09,040
OTHER COMMENTS OR OBSERVATIONS? 

3098
02:02:09,040 --> 02:02:12,000
>> THIS IS PEARL.

3099
02:02:12,000 --> 02:02:13,520
KEVIN, I HOPE I'M ARTICULATE

3100
02:02:13,520 --> 02:02:14,720
ENOUGH TO GET THIS ACROSS.

3101
02:02:14,720 --> 02:02:16,920
ALL TRY.

3102
02:02:16,920 --> 02:02:18,640
I'M TRYING TO PUT TOGETHER,

3103
02:02:18,640 --> 02:02:20,320
YESTERDAY AND TODAY, THE MEETING

3104
02:02:20,320 --> 02:02:24,360
YET THERE WAS A LOT OF

3105
02:02:24,360 --> 02:02:27,720
DISCUSSION ABOUT IMPLEMENTATION

3106
02:02:27,720 --> 02:02:29,600
YESTERDAY, YOU SHOULD YOU ONLY

3107
02:02:29,600 --> 02:02:32,520
DO RESEARCH CAN YOU SHOW IT WILL

3108
02:02:32,520 --> 02:02:35,680
BE IMPLEMENTED, THIS IS

3109
02:02:35,680 --> 02:02:36,040
IMPLEMENTABLE.

3110
02:02:36,040 --> 02:02:37,800
SOMEONE SAID ACTUALLY THEY ARE

3111
02:02:37,800 --> 02:02:39,520
REQUIRING THERE BE A COMMITMENT

3112
02:02:39,520 --> 02:02:42,160
TO IMPLEMENTATION AND HENCE

3113
02:02:42,160 --> 02:02:44,360
LEADERSHIP WEIGHING IN EARLY.

3114
02:02:44,360 --> 02:02:48,840
I'M WONDERING HOW THAT AFFECTS

3115
02:02:48,840 --> 02:02:50,920
GO/NO-GO DECISIONS OR CHANGES?

3116
02:02:50,920 --> 02:02:53,200
IF YOU HAVE TO -- THINKING OF

3117
02:02:53,200 --> 02:02:59,880
LET'S SAY WITH COVID, WHERE I

3118
02:02:59,880 --> 02:03:01,600
THINK IT WAS NATALIA'S STUDY,

3119
02:03:01,600 --> 02:03:03,400
THERE WAS GOING TO BE IN-PERSON

3120
02:03:03,400 --> 02:03:06,640
AND HAD TO GO TO REMOTE BECAUSE

3121
02:03:06,640 --> 02:03:07,440
OF COVID.

3122
02:03:07,440 --> 02:03:10,240
WHAT IS THE INSTITUTION SAYS WE

3123
02:03:10,240 --> 02:03:11,680
CAN'T SUPPORT REMOTE?

3124
02:03:11,680 --> 02:03:14,720
HOW WOULD THAT KIND OF NO-GO

3125
02:03:14,720 --> 02:03:15,640
DECISION HAPPEN?

3126
02:03:15,640 --> 02:03:18,160
WE WERE TALKING REALLY MORE

3127
02:03:18,160 --> 02:03:20,320
ABOUT SAFETY AND STATISTICAL

3128
02:03:20,320 --> 02:03:21,760
FINDINGS, BUT I THINK WE NEED TO

3129
02:03:21,760 --> 02:03:24,920
THINK ABOUT IS THIS RESEARCH

3130
02:03:24,920 --> 02:03:32,280
GOING TO REALLY ADD TO HELPING

3131
02:03:32,280 --> 02:03:33,880
PEOPLE, HENCE BE IMPLEMENTABLE,

3132
02:03:33,880 --> 02:03:36,520
HOW DO WE HANDLE NEW POLICIES,

3133
02:03:36,520 --> 02:03:38,040
NEW ISSUES THAT CAME IN?

3134
02:03:38,040 --> 02:03:39,640
I HOPE THAT MADE SENSE?

3135
02:03:39,640 --> 02:03:45,640
>> YEP, I THINK YOU'RE
LOOKING

3136
02:03:45,640 --> 02:03:46,800
FORWARD, ANTICIPATING.

3137
02:03:46,800 --> 02:03:48,480
I THINK DECISIONS NEED TO BE

3138
02:03:48,480 --> 02:03:50,520
MADE BACKWARDS IN TIME DATA, ROO

3139
02:03:50,520 --> 02:03:50,840
IT?

3140
02:03:50,840 --> 02:03:55,360
IF IT'S A COVID ISSUE, TEAMS TRY

3141
02:03:55,360 --> 02:03:58,640
TO PIVOT AND CHANGE THE

3142
02:03:58,640 --> 02:04:01,600
INTERVENTION, AS THAT HAPPENS

3143
02:04:01,600 --> 02:04:03,040
DATA WILL LEAVE A TRACK TO SAY

3144
02:04:03,040 --> 02:04:06,520
WHETHER THIS IS WORKING OR NOT

3145
02:04:06,520 --> 02:04:08,400
AND HAVE CONTEXT, IT'S NOT JUST

3146
02:04:08,400 --> 02:04:10,160
ONE NUMBER, IT'S A NUMBER IN THE

3147
02:04:10,160 --> 02:04:11,440
CONTEXT OF THE SITUATION OF MANY

3148
02:04:11,440 --> 02:04:13,000
NUMBERS, RIGHT?

3149
02:04:13,000 --> 02:04:16,840
DOES THAT MAKE THE CASE THAT THE

3150
02:04:16,840 --> 02:04:20,680
LIKELIHOOD THIS IS NOT GOING TO

3151
02:04:20,680 --> 02:04:20,960
WORK OUT?

3152
02:04:20,960 --> 02:04:22,440
>> RIGHT.

3153
02:04:22,440 --> 02:04:24,640
>> UNLESS IT'S AN ISSUE
OF

3154
02:04:24,640 --> 02:04:26,560
ETHICS, SAFETY, IN THE PIVOT OR

3155
02:04:26,560 --> 02:04:28,000
WHATEVER CHANGE THEY MAKE BUT

3156
02:04:28,000 --> 02:04:29,120
THAT'S A DIFFERENT ISSUE, THAT

3157
02:04:29,120 --> 02:04:33,120
WILL GO THROUGH THE IRB.

3158
02:04:33,120 --> 02:04:35,320
>> YEAH, NO, I PROMISE I
WILL

3159
02:04:35,320 --> 02:04:37,280
NOT BEAT THIS DEAD HORSE, BUT I

3160
02:04:37,280 --> 02:04:40,480
WAS MORE THINKING IF YOUR PIVOT

3161
02:04:40,480 --> 02:04:41,320
ACTUALLY REQUIRED DIFFERENT

3162
02:04:41,320 --> 02:04:42,840
RESOURCES, ET CETERA, THAT THE

3163
02:04:42,840 --> 02:04:44,280
INSTITUTION HAD NOT AGREED TO AT

3164
02:04:44,280 --> 02:04:46,600
THE BEGINNING, THAT THEY WOULD

3165
02:04:46,600 --> 02:04:47,480
BE ABLE TO IMPLEMENT.

3166
02:04:47,480 --> 02:04:51,000
IT SEEMS LIKE SOMETHING WE DON'T

3167
02:04:51,000 --> 02:04:51,440
CONSIDER.

3168
02:04:51,440 --> 02:04:53,480
I JUST -- TODAY AND YESTERDAY,

3169
02:04:53,480 --> 02:04:55,120
I'M JUST THINKING WE NEED TO PUT

3170
02:04:55,120 --> 02:04:58,280
A LITTLE MORE ENERGY INTO

3171
02:04:58,280 --> 02:05:00,920
LOOKING AT THE SO WHAT QUESTION

3172
02:05:00,920 --> 02:05:02,120
ABOUT THE RESEARCH, IS THIS

3173
02:05:02,120 --> 02:05:05,520
GOING TO SOMETHING THAT CAN BE

3174
02:05:05,520 --> 02:05:05,920
IMPLEMENTED?

3175
02:05:05,920 --> 02:05:08,360
I DON'T THINK WE SPENT ENOUGH

3176
02:05:08,360 --> 02:05:11,320
TIME THERE, BOTH INITIALLY AND

3177
02:05:11,320 --> 02:05:12,960
ONGOING IN THE STUDY.

3178
02:05:12,960 --> 02:05:18,000
I'LL STOP THERE.

3179
02:05:18,000 --> 02:05:18,560
>> I AGREE.

3180
02:05:18,560 --> 02:05:22,160
>> THANK YOU, SHERYL.

3181
02:05:22,160 --> 02:05:24,480
>> I THINK IT'S IMPORTANT
WE

3182
02:05:24,480 --> 02:05:26,520
HAVE MULTIPLE STAKEHOLDERS IN

3183
02:05:26,520 --> 02:05:27,280
TERMS OF INPUT BECAUSE AT THAT

3184
02:05:27,280 --> 02:05:29,280
TIME WE MAY BE ABLE TO HAVE A

3185
02:05:29,280 --> 02:05:31,760
BETTER DESIGN WHICH WOULD LEAD

3186
02:05:31,760 --> 02:05:36,960
TO A BETTER DESIGN THAT IS GOING

3187
02:05:36,960 --> 02:05:37,360
TO BE SUSTAINABLE.

3188
02:05:37,360 --> 02:05:40,920
>> CORITA, WHAT DO YOU
WANT TO

3189
02:05:40,920 --> 02:05:41,080
ADD?

3190
02:05:41,080 --> 02:05:43,320
>> COULD NOT AGREE MORE
WITH

3191
02:05:43,320 --> 02:05:47,320
PEARL, YOUR STATEMENT, AND I'LL

3192
02:05:47,320 --> 02:05:49,000
JUST SAY ANECDOTALLY PCORI DOES

3193
02:05:49,000 --> 02:05:50,680
THIS REALLY WELL.

3194
02:05:50,680 --> 02:05:53,440
THEY HAVE GO NO GO CRITERIA, IF

3195
02:05:53,440 --> 02:05:55,840
YOU CANNOT IMPLEMENT YOUR TRIAL,

3196
02:05:55,840 --> 02:05:57,080
COMPARATIVE EFFECT, WHATEVER

3197
02:05:57,080 --> 02:05:59,640
YOU'RE DOING, YOU HAVE TO BE

3198
02:05:59,640 --> 02:06:01,960
DESCOPE THE STUDY, THAT HAPPENED

3199
02:06:01,960 --> 02:06:06,920
TWO OUT OF THE TEN PALLIATIVE

3200
02:06:06,920 --> 02:06:08,000
CARE STUDIES, PHASE AWARDS ARE A

3201
02:06:08,000 --> 02:06:09,720
GREAT WAY TO DO THAT.

3202
02:06:09,720 --> 02:06:17,280
>> CAN YOU EXPLAIN
DESCOPING

3203
02:06:17,280 --> 02:06:17,720
FOR FOX NOT FAMILY?

3204
02:06:17,720 --> 02:06:19,960
>> YOU TO HOWE CAN YOU
REVISE

3205
02:06:19,960 --> 02:06:21,600
AMIES -- HOW CAN YOU REVISE THE

3206
02:06:21,600 --> 02:06:21,880
AIMS.

3207
02:06:21,880 --> 02:06:25,200
THERE'S AN EXAMPLE FROM KAISER,

3208
02:06:25,200 --> 02:06:27,040
IN SOUTHERN CALIFORNIA A THEY

3209
02:06:27,040 --> 02:06:29,480
WERE GOING TO DO A STUDY OF

3210
02:06:29,480 --> 02:06:31,160
TELEHEALTH PALLIATIVE CARE IN

3211
02:06:31,160 --> 02:06:33,280
THE HOME, I CAN'T REMEMBER THE

3212
02:06:33,280 --> 02:06:34,440
CONTROL OR INTERVENTION BUT

3213
02:06:34,440 --> 02:06:35,160
KAISER DECIDED THEY WERE JUST

3214
02:06:35,160 --> 02:06:38,320
GOING TO DO IT IN EVERYONE

3215
02:06:38,320 --> 02:06:39,720
WITHOUT EVIDENCE BUT DECIDED TO

3216
02:06:39,720 --> 02:06:45,920
IMPLEMENT FOR EVERYONE SO THERE

3217
02:06:45,920 --> 02:06:47,960
WAS NO LONGER ANY QUESTION THEY

3218
02:06:47,960 --> 02:06:48,880
COULD ASK.

3219
02:06:48,880 --> 02:06:52,160
THAT WAS -- SOUTHERN CALIFORNIA

3220
02:06:52,160 --> 02:06:52,800
SEEMS PARTICULARLY PROBLEMATIC.

3221
02:06:52,800 --> 02:06:54,520
I DON'T KNOW WHY THE OTHER STUDY

3222
02:06:54,520 --> 02:06:56,360
WAS ALSO SOUTHERN CALIFORNIA.

3223
02:06:56,360 --> 02:06:58,400
AND SO DESCOPING IS LIKE

3224
02:06:58,400 --> 02:07:00,040
REVISING THE AIMS, REVISING THE

3225
02:07:00,040 --> 02:07:01,600
BUDGET, AND SAYING HOW CAN I GET

3226
02:07:01,600 --> 02:07:04,560
THE MOST OUT OF WHAT HAPPENED TO

3227
02:07:04,560 --> 02:07:06,320
CONVEY LEARNINGS TO THE

3228
02:07:06,320 --> 02:07:09,360
SCIENTIFIC AND BROADER

3229
02:07:09,360 --> 02:07:09,640
COMMUNITY.

3230
02:07:09,640 --> 02:07:09,880
>> OKAY.

3231
02:07:09,880 --> 02:07:11,600
>> IT'S LIKE REWRITING
YOUR

3232
02:07:11,600 --> 02:07:11,800
GRANT.

3233
02:07:11,800 --> 02:07:12,840
SOUNDS REALLY PAINFUL.

3234
02:07:12,840 --> 02:07:15,120
I'VE NOT HAD TO DO IT.

3235
02:07:15,120 --> 02:07:18,680
>> SOUNDS MORE LIKE
RESCOPING.

3236
02:07:18,680 --> 02:07:19,680
DESCOPEING SOUNDS LIKE YOU'RE

3237
02:07:19,680 --> 02:07:22,520
REMOVING ANY POINT TO THE WHOLE

3238
02:07:22,520 --> 02:07:22,720
THING.

3239
02:07:22,720 --> 02:07:24,600
>> WELL, THE SCOPE IS
MUCH

3240
02:07:24,600 --> 02:07:27,360
SMALLER BECAUSE THESE WERE

3241
02:07:27,360 --> 02:07:28,600
MULTIPLE MILLION DOLLAR AWARDS,

3242
02:07:28,600 --> 02:07:29,960
LIKE $10 MILLION AWARD.

3243
02:07:29,960 --> 02:07:32,160
DESCOPE MEANING THE SCOPE IS NOW

3244
02:07:32,160 --> 02:07:33,680
A MILLION DOLLARS PROBABLY

3245
02:07:33,680 --> 02:07:35,040
BECAUSE YOU'RE JUST GOING

3246
02:07:35,040 --> 02:07:35,760
QUALITATIVE INTERVIEWS AND

3247
02:07:35,760 --> 02:07:38,040
UNDERSTANDING WHY IT DIDN'T WORK

3248
02:07:38,040 --> 02:07:40,240
AND, YEAH, THAT'S WHAT I MEANT

3249
02:07:40,240 --> 02:07:43,680
BY DESCOPE.

3250
02:07:43,680 --> 02:07:45,920
>> GREAT, THANK YOU.

3251
02:07:45,920 --> 02:07:48,120
WE'RE APPROACHING END OF OUR

3252
02:07:48,120 --> 02:07:48,760
SESSION HERE.

3253
02:07:48,760 --> 02:07:51,160
WE HEARD SO MANY GOOD POINTS.

3254
02:07:51,160 --> 02:07:54,720
WE STARTED OUT WITH OUR THREE

3255
02:07:54,720 --> 02:07:56,680
COLLABORATORY P.I.s,

3256
02:07:56,680 --> 02:07:58,960
DISCUSSING THIS QUESTION OF WHAT

3257
02:07:58,960 --> 02:08:03,000
OPPORTUNITIES AND CHALLENGES ARE

3258
02:08:03,000 --> 02:08:05,000
THEREFORE LEARNING SOONER, AND

3259
02:08:05,000 --> 02:08:06,600
WE'RE EMPHASIZING LEARNING

3260
02:08:06,600 --> 02:08:07,920
SOONER, NOT FAILING FASTER,

3261
02:08:07,920 --> 02:08:09,440
WHICH WAS AN INITIAL PHRASE WE

3262
02:08:09,440 --> 02:08:11,120
USED WHEN PLANNING THIS

3263
02:08:11,120 --> 02:08:13,600
WORKSHOP, BUT LEARNING SOONER.

3264
02:08:13,600 --> 02:08:17,000
AND HEARD SOME EXAMPLES OF

3265
02:08:17,000 --> 02:08:19,440
EXPLICITLY BUILDING IN THAT

3266
02:08:19,440 --> 02:08:22,920
LEARNING AS PART OF THE FORM OF

3267
02:08:22,920 --> 02:08:23,920
THE INTERVENTION.

3268
02:08:23,920 --> 02:08:26,640
AND HOW TO REACT TO THAT AND THE

3269
02:08:26,640 --> 02:08:27,720
ROLE OF MULTI-STAKEHOLDER

3270
02:08:27,720 --> 02:08:31,960
PANELS, AND THAT WE ALSO HEARD

3271
02:08:31,960 --> 02:08:34,960
ABOUT CHOOSING DESIGNS THAT WILL

3272
02:08:34,960 --> 02:08:37,920
ALLOW US MAXIMUM FLEXIBILITY IN

3273
02:08:37,920 --> 02:08:40,960
RESPONDING TO INCOMING SIGNALS.

3274
02:08:40,960 --> 02:08:44,560
WE HEARD ABOUT THE POTENTIAL FOR

3275
02:08:44,560 --> 02:08:47,880
EARLIER AND MORE LEARNING, WITH

3276
02:08:47,880 --> 02:08:49,840
A BIT MORE TIME AVAILABLE IN THE

3277
02:08:49,840 --> 02:08:50,920
PLANNING PHASE, ESPECIALLY IN

3278
02:08:50,920 --> 02:08:52,880
CASES WHERE WE'RE GOING TO BE

3279
02:08:52,880 --> 02:08:56,080
DOING THE RESEARCH IN SETTINGS

3280
02:08:56,080 --> 02:08:58,920
THAT ARE LESS EXPERIENCED WITH

3281
02:08:58,920 --> 02:09:00,880
RESEARCH OR UNDERRESOURCED FOR

3282
02:09:00,880 --> 02:09:02,960
WHICH MORE TIME THAN IS

3283
02:09:02,960 --> 02:09:04,760
TYPICALLY THE CASE WILL BE

3284
02:09:04,760 --> 02:09:05,960
REQUIRED TO FIND OUT WHAT THINGS

3285
02:09:05,960 --> 02:09:07,880
WE NEED TO LEARN IN THOSE

3286
02:09:07,880 --> 02:09:08,160
SETTINGS.

3287
02:09:08,160 --> 02:09:12,800
SO I THOUGHT THAT WAS A REALLY

3288
02:09:12,800 --> 02:09:13,920
INTERESTING POINT.

3289
02:09:13,920 --> 02:09:20,600
AND THEN WE HEARD A WHOLE HOST

3290
02:09:20,600 --> 02:09:23,240
OF CONSIDERATIONS, LOGISTIC,

3291
02:09:23,240 --> 02:09:24,000
ADMINISTRATIVE, BIOETHICAL,

3292
02:09:24,000 --> 02:09:25,080
STATISTICAL, IN EXAMINING THE

3293
02:09:25,080 --> 02:09:30,320
RANGE OF SIGNALS THAT MIGHT BE

3294
02:09:30,320 --> 02:09:32,400
COMING IN AND MAKING DECISIONS

3295
02:09:32,400 --> 02:09:35,240
BASED ON WHAT HAPPENS NEXT AND

3296
02:09:35,240 --> 02:09:37,760
KEVIN TALKED ABOUT CHANGING THIS

3297
02:09:37,760 --> 02:09:41,200
CULTURE TO MAKE IT MORE

3298
02:09:41,200 --> 02:09:42,600
ACCEPTABLE TO SAY, HEY,

3299
02:09:42,600 --> 02:09:44,600
SOMETHING'S HAPPENED, WE NEED TO

3300
02:09:44,600 --> 02:09:45,640
PIVOT IN SOME WAY.

3301
02:09:45,640 --> 02:09:48,080
I THINK ONE OF THE THINGS THAT

3302
02:09:48,080 --> 02:09:53,760
OUR WORKSHOP PLANNING GROUP

3303
02:09:53,760 --> 02:09:55,080
RECOGNIZED IS THAT CHANGING

3304
02:09:55,080 --> 02:09:57,080
CULTURE MIGHT ALSO NECESSITATE A

3305
02:09:57,080 --> 02:10:00,800
CHANGE IN THE STRUCTURES AND

3306
02:10:00,800 --> 02:10:01,640
PROCESSES AND INCENTIVES FOR

3307
02:10:01,640 --> 02:10:03,960
RESEARCH IN WHICH ALL OF OUR

3308
02:10:03,960 --> 02:10:04,600
RESEARCHERS ARE PRACTICING.

3309
02:10:04,600 --> 02:10:07,240
AND SO THAT'S THE ISSUE THAT

3310
02:10:07,240 --> 02:10:11,200
WE'LL ADDRESS IN OUR FOURTH

3311
02:10:11,200 --> 02:10:11,960
PANEL.

3312
02:10:11,960 --> 02:10:13,160
MY COLLEAGUE RICH PLATT WILL

3313
02:10:13,160 --> 02:10:14,160
LEAD THAT AFTER THE BREAK.

3314
02:10:14,160 --> 02:10:15,400
WE'RE GOING TO TAKE A BREAK

3315
02:10:15,400 --> 02:10:17,800
RIGHT NOW AND COME BACK AT

3316
02:10:17,800 --> 02:10:18,000
12:25.

3317
02:10:18,000 --> 02:10:20,720
I WANT TO THANK ALL THE

3318
02:10:20,720 --> 02:10:22,240
PANELISTS FOR A REALLY, REALLY

3319
02:10:22,240 --> 02:10:23,120
INTERESTING DISCUSSION AND FOR

3320
02:10:23,120 --> 02:10:26,640
SHARING ALL OF YOUR EXPERIENCES

3321
02:10:26,640 --> 02:10:28,080
AND PERSPECTIVES.

3322
02:10:28,080 --> 02:10:29,280
AND EVERYONE HAVE A GOOD BREAK,

3323
02:10:29,280 --> 02:10:32,320
WE'LL SEE YOU BACK AT 12:25. 

3324
02:10:32,320 --> 02:10:35,880
THANKS SO MUCH.

3325
02:10:35,880 --> 02:10:38,000
I'M RICHARD PLATT, I'M GOING TO

3326
02:10:38,000 --> 02:10:44,880
MODERATE THIS LAST SESSION.

3327
02:10:44,880 --> 02:10:46,720
THIS IS UP TO A ONE-HOUR SESSION

3328
02:10:46,720 --> 02:10:50,320
TO BRING TOGETHER A NUMBER OF

3329
02:10:50,320 --> 02:10:54,840
THREADS THAT WE'VE BEEN

3330
02:10:54,840 --> 02:10:55,520
DISCUSSING, PARTICULAR TO

3331
02:10:55,520 --> 02:10:57,120
CONTINUE THE DISCUSSION WE HAD

3332
02:10:57,120 --> 02:11:02,800
IN THE FIRST PART OF TODAY'S

3333
02:11:02,800 --> 02:11:03,800
MEETING.

3334
02:11:03,800 --> 02:11:10,400
IN PARTICULAR, SO FIRST, BEFORE

3335
02:11:10,400 --> 02:11:17,040
I INTRODUCE THE PANELISTS, WE

3336
02:11:17,040 --> 02:11:19,120
MADE MUCH IN THE LAST SESSION

3337
02:11:19,120 --> 02:11:21,720
ONE NEEDS TO ADAPT THE

3338
02:11:21,720 --> 02:11:23,080
INTERVENTION BEING EVALUATED,

3339
02:11:23,080 --> 02:11:24,280
BUT THE DECISION BETWEEN

3340
02:11:24,280 --> 02:11:28,120
ADAPTING AND JUST CHANGING THE

3341
02:11:28,120 --> 02:11:31,840
INTERVENTION FALLS ON A

3342
02:11:31,840 --> 02:11:32,280
SPECTRUM.

3343
02:11:32,280 --> 02:11:37,760
AT LEAST IN THE CONTEXT OF THE

3344
02:11:37,760 --> 02:11:38,640
COLLABORATORY INVESTIGATIONS,

3345
02:11:38,640 --> 02:11:44,880
THOSE ARE IN THE CONTEXT OF

3346
02:11:44,880 --> 02:11:45,840
PROPOSALS REVIEWED AND APPROVED

3347
02:11:45,840 --> 02:11:49,920
BY A -- RECOMMENDED BY A STUDY

3348
02:11:49,920 --> 02:11:54,760
SECTION, AND THERE ARE REAL

3349
02:11:54,760 --> 02:11:57,480
QUESTIONS ABOUT HOW MUCH CHANGE

3350
02:11:57,480 --> 02:12:00,760
IS ACCEPTABLE IN THE CONTEXT OF

3351
02:12:00,760 --> 02:12:04,120
THE APPROVED PROTOCOL.

3352
02:12:04,120 --> 02:12:10,720
SO, TO SORT OF THINK ABOUT HOW

3353
02:12:10,720 --> 02:12:16,600
TO ACCOMMODATE THE LEGITIMATE

3354
02:12:16,600 --> 02:12:20,040
NEED FOR CHANGE WITH APPROVED

3355
02:12:20,040 --> 02:12:23,760
PROTOCOLS WE'RE CONSIDERING, WE

3356
02:12:23,760 --> 02:12:28,240
HAVE THREE NIH PROGRAM STAFF TO

3357
02:12:28,240 --> 02:12:29,880
LEAD OFF DISCUSSIONS, AND WE

3358
02:12:29,880 --> 02:12:32,520
HAVE A NUMBER OF INVESTIGATORS

3359
02:12:32,520 --> 02:12:36,560
WHO ARE GOING TO PARTICIPATE IN

3360
02:12:36,560 --> 02:12:39,280
THE CONVERSATION, FROM THE NIH

3361
02:12:39,280 --> 02:12:43,960
DAVID CHAMBERS WHO IS DEPUTY

3362
02:12:43,960 --> 02:12:44,800
DIRECTOR FOR IMPLEMENTATION

3363
02:12:44,800 --> 02:12:46,520
SCIENCE AND OFFICE OF DIRECTOR

3364
02:12:46,520 --> 02:12:50,800
OF CANCER CONTROL POPULATION

3365
02:12:50,800 --> 02:12:56,600
SCIENCES, DIVISION OF THE NCI IS

3366
02:12:56,600 --> 02:12:56,880
HERE.

3367
02:12:56,880 --> 02:13:00,920
WYNNE NORTON FROM THE SAME

3368
02:13:00,920 --> 02:13:03,880
DIVISION, AND TISHA WILEY, CHIEF

3369
02:13:03,880 --> 02:13:10,320
OF SERVICES RESEARCH BRANCH OF

3370
02:13:10,320 --> 02:13:11,560
NIGHT.

3371
02:13:11,560 --> 02:13:12,840
GEORGE SOPKO HAD AN UNAVOIDABLE

3372
02:13:12,840 --> 02:13:19,680
CONFLICT AND WON'T BE WITH US.

3373
02:13:19,680 --> 02:13:21,200
AND GLORIA, NATALIA, AND CORITA

3374
02:13:21,200 --> 02:13:24,480
WHO HAVE BEEN WITH US ALL

3375
02:13:24,480 --> 02:13:29,520
MORNING AGREED TO STAY ON AND

3376
02:13:29,520 --> 02:13:39,280
KEN SANDS AND SEPTIMUS, PART OF

3377
02:13:39,280 --> 02:13:49,800
THE ABATE DISCUSSION YESTERDAY.

3378
02:13:50,040 --> 02:13:53,280
WE'VE DAVID AND WYNNE TO SPEAK

3379
02:13:53,280 --> 02:13:57,120
AND INVITED REST TO COMMENT AND

3380
02:13:57,120 --> 02:13:58,440
WE'LL HAVE A FINAL MINUTES IF WE

3381
02:13:58,440 --> 02:14:02,240
WANT TO USE IT FOR THE WHOLE

3382
02:14:02,240 --> 02:14:07,200
GROUP AND EVERYONE IN THE

3383
02:14:07,200 --> 02:14:08,160
AUDIENCE TO PARTICIPATE.

3384
02:14:08,160 --> 02:14:10,880
WITH THAT AS A LEAD-OFF, DAVID,

3385
02:14:10,880 --> 02:14:12,400
THE FLOOR IS YOURS.

3386
02:14:12,400 --> 02:14:13,880
>> THANKS, RICH.

3387
02:14:13,880 --> 02:14:17,040
THANKS TO EVERYONE FOR ENGAGING

3388
02:14:17,040 --> 02:14:21,120
IN SUCH GREAT DISCUSSIONS OVER

3389
02:14:21,120 --> 02:14:22,160
THE LAST DAY-PLUS.

3390
02:14:22,160 --> 02:14:24,960
THERE'S BEEN A LOT OF

3391
02:14:24,960 --> 02:14:25,720
CONVERSATION ABOUT

3392
02:14:25,720 --> 02:14:26,200
IMPLEMENTATION SCIENCE,

3393
02:14:26,200 --> 02:14:26,760
IMPLEMENTATION QUESTIONS.

3394
02:14:26,760 --> 02:14:28,800
SO ONE OF THE THINGS WE THINK

3395
02:14:28,800 --> 02:14:30,720
ABOUT IN IMPLEMENTATION SCIENCE

3396
02:14:30,720 --> 02:14:32,640
IS HOW IMPORTANT CONTEXT IS AND

3397
02:14:32,640 --> 02:14:33,600
NO QUESTION, THERE'S BEEN A LOT

3398
02:14:33,600 --> 02:14:35,120
OF COMMENTS TO THIS END.

3399
02:14:35,120 --> 02:14:37,440
I LIKE TO START WITH JUST BRIEF

3400
02:14:37,440 --> 02:14:38,800
CONTEXT FOR THE COMMENTS THAT

3401
02:14:38,800 --> 02:14:40,360
I'M ABOUT TO MAKE.

3402
02:14:40,360 --> 02:14:42,160
IT STARTS WITH GRATITUDE FOR MY

3403
02:14:42,160 --> 02:14:46,080
FELLOW NIH FOLKS AS PART OF THIS

3404
02:14:46,080 --> 02:14:47,480
GROUP AND BEYOND.

3405
02:14:47,480 --> 02:14:49,160
CERTAINLY THE WONDERFUL WORK IN

3406
02:14:49,160 --> 02:14:51,200
THE COLLABORATORY, PARTICULARLY

3407
02:14:51,200 --> 02:14:55,040
WANT TO SHOUT OUT WYNNE LEADING

3408
02:14:55,040 --> 02:14:56,440
EFFORTS IN OUR DIVISION TO

3409
02:14:56,440 --> 02:14:58,320
ADVANCE OUR COLLECTIVE THINKING

3410
02:14:58,320 --> 02:14:59,840
ABOUT PRAGMATIC TRIALS ACROSS

3411
02:14:59,840 --> 02:15:00,960
CANCER, LOOKING FORWARD TO HER

3412
02:15:00,960 --> 02:15:02,880
COMMENTS AS WELL.

3413
02:15:02,880 --> 02:15:04,120
I HAVE BEEN ENGAGED IN THE

3414
02:15:04,120 --> 02:15:05,080
COLLABORATORY SINCE THE

3415
02:15:05,080 --> 02:15:07,000
BEGINNING AND REALLY RESONATE

3416
02:15:07,000 --> 02:15:13,320
WITH PEARL'S NOTE OF THE "SO

3417
02:15:13,320 --> 02:15:15,080
WHAT" QUESTION, IT'S SOMETHING

3418
02:15:15,080 --> 02:15:15,960
WITHIN THE PRAGMATIC TRIALS

3419
02:15:15,960 --> 02:15:18,920
ENTERPRISE COMES UP AGAIN AND

3420
02:15:18,920 --> 02:15:19,800
AGAIN, INCREDIBLY IMPORTANT.

3421
02:15:19,800 --> 02:15:22,760
I WANT TO QUICKLY NOTE SOME

3422
02:15:22,760 --> 02:15:24,160
COMMENTS GENERATED BY THE

3423
02:15:24,160 --> 02:15:25,720
WONDERFUL WORK OF FOLKS WITHIN

3424
02:15:25,720 --> 02:15:26,920
THE MENTAL HEALTH RESEARCH

3425
02:15:26,920 --> 02:15:28,600
NETWORK, WHICH HAS BEEN FUNDED

3426
02:15:28,600 --> 02:15:31,400
BY NIMH FOR A WHILE THAT I HAD

3427
02:15:31,400 --> 02:15:33,240
THE PRIVILEGE OF GETTING TO WORK

3428
02:15:33,240 --> 02:15:34,880
WITH IN EARLY DAYS.

3429
02:15:34,880 --> 02:15:37,200
OTHER COMMENTS RELEVANT TO OUR

3430
02:15:37,200 --> 02:15:38,280
ONGOING IMPLEMENTATION SCIENCE

3431
02:15:38,280 --> 02:15:42,320
CENTERS AND CANCER CONTROL, A

3432
02:15:42,320 --> 02:15:43,080
SET OF CANCER MOONSHOT-FUNDED

3433
02:15:43,080 --> 02:15:44,280
INVESTIGATORS THINKING ABOUT THE

3434
02:15:44,280 --> 02:15:47,280
NEXT STEPS IN THE SPACE OF

3435
02:15:47,280 --> 02:15:48,880
IMPLEMENTATION SCIENCE AND

3436
02:15:48,880 --> 02:15:49,680
CERTAINLY WHERE EFFECTIVENESS

3437
02:15:49,680 --> 02:15:50,320
ALSO TAKES ROOT.

3438
02:15:50,320 --> 02:15:53,480
AND THEN THE OTHER BIT OF

3439
02:15:53,480 --> 02:15:54,920
CONTEXT IS JUST HAVING THE

3440
02:15:54,920 --> 02:15:59,280
ABILITY TO LEARN FROM SO MANY

3441
02:15:59,280 --> 02:15:59,920
EFFECTIVENESS AN IMPLEMENTATION

3442
02:15:59,920 --> 02:16:01,960
TRIALISTS OVER THE YEARS IN

3443
02:16:01,960 --> 02:16:03,680
MENTAL HEALTH AND CANCER AND

3444
02:16:03,680 --> 02:16:04,360
BEYOND.

3445
02:16:04,360 --> 02:16:06,840
CORE TO ALL OF THESE PARTICULAR

3446
02:16:06,840 --> 02:16:08,400
ACTIVITIES IS SOMETHING THAT I

3447
02:16:08,400 --> 02:16:10,920
THINK IS CENTRAL TO A LOT OF

3448
02:16:10,920 --> 02:16:13,760
WORK OF COLLABORATORY, DIRECT

3449
02:16:13,760 --> 02:16:14,840
AND ONGOING DIRECTIONS BETWEEN

3450
02:16:14,840 --> 02:16:15,920
COMMUNITY LEADERS AND PRACTICE

3451
02:16:15,920 --> 02:16:16,680
PARTNERS.

3452
02:16:16,680 --> 02:16:18,880
I THINK IT'S BOTH IN TERMS OF

3453
02:16:18,880 --> 02:16:21,480
WHAT CAN WE ANTICIPATE AND THEN

3454
02:16:21,480 --> 02:16:23,200
WHAT -- AS A RESULT OF WHAT WE

3455
02:16:23,200 --> 02:16:25,800
CAN ANTICIPATE, HOW DO WE

3456
02:16:25,800 --> 02:16:27,240
DEVELOP STRATEGIES TO ADDRESS

3457
02:16:27,240 --> 02:16:28,040
CHALLENGES.

3458
02:16:28,040 --> 02:16:31,200
AS RICH WAS SAYING, WHEN WE --

3459
02:16:31,200 --> 02:16:32,520
WHEN THINGS COME UP WE'RE NOT

3460
02:16:32,520 --> 02:16:33,720
EXPECTING HOW CAN WE TAKE

3461
02:16:33,720 --> 02:16:34,760
ADVANTAGE OF SOME PARTNERSHIPS

3462
02:16:34,760 --> 02:16:37,440
TO TRY AND MANAGE, TO STUDY, TO

3463
02:16:37,440 --> 02:16:39,400
LEARN FROM THESE UNEXPECTED

3464
02:16:39,400 --> 02:16:39,920
EVENTS.

3465
02:16:39,920 --> 02:16:41,600
THERE'S SORT OF TWO BROAD

3466
02:16:41,600 --> 02:16:43,280
BUCKETS THAT I THINK THE MAIN

3467
02:16:43,280 --> 02:16:44,640
COMMENTS THAT I'D LIKE TO MAKE

3468
02:16:44,640 --> 02:16:46,080
FALL WITHIN.

3469
02:16:46,080 --> 02:16:48,400
THE FIRST ONE IS REALLY RELATED

3470
02:16:48,400 --> 02:16:50,440
TO THIS NOTION OF WHAT'S BASED

3471
02:16:50,440 --> 02:16:51,880
WITHIN OUR CLINICAL AND

3472
02:16:51,880 --> 02:16:53,200
COMMUNITY SYSTEMS AND THEN WHAT

3473
02:16:53,200 --> 02:16:55,680
ARE WAYS THAT WE CAN LEVERAGE

3474
02:16:55,680 --> 02:16:56,360
PARTNERSHIPS TOWARD ADDRESSING

3475
02:16:56,360 --> 02:16:59,240
THEM AND THE OTHER ONE IS

3476
02:16:59,240 --> 02:17:00,880
RELATED TO UNEXPECTED EVENTS

3477
02:17:00,880 --> 02:17:01,720
THAT CROPPED UP CERTAINLY OVER

3478
02:17:01,720 --> 02:17:03,720
THE LAST FEW YEARS BUT HAVE

3479
02:17:03,720 --> 02:17:05,120
ALWAYS BEEN WITH US, THE IDEA

3480
02:17:05,120 --> 02:17:07,880
THAT AS MUCH AS WE PLAN WE KNOW

3481
02:17:07,880 --> 02:17:09,800
THAT THE UNKNOWN IS LURKING AND

3482
02:17:09,800 --> 02:17:12,160
SOMETIMES THAT CAN BE A POSITIVE

3483
02:17:12,160 --> 02:17:14,320
THING, CAN REALLY HELP US LEARN,

3484
02:17:14,320 --> 02:17:16,280
OTHER TIMES IT BECOMES A HASSLE.

3485
02:17:16,280 --> 02:17:19,360
ON THE CLINICAL OR COMMUNITY

3486
02:17:19,360 --> 02:17:20,440
SYSTEM-BASED SIDE CERTAINLY SOME

3487
02:17:20,440 --> 02:17:22,520
STRATEGIES THAT WE THOUGHT ABOUT

3488
02:17:22,520 --> 02:17:23,640
AND CERTAINLY THAT OUR

3489
02:17:23,640 --> 02:17:24,280
INVESTIGATORS HAVE TAKEN

3490
02:17:24,280 --> 02:17:26,120
ADVANTAGE OF IS THINKING ABOUT

3491
02:17:26,120 --> 02:17:28,160
THE DIRECT INVOLVEMENT OF OUR

3492
02:17:28,160 --> 02:17:31,600
CLINICAL SYSTEM LEADS ON THE

3493
02:17:31,600 --> 02:17:34,120
INVESTIGATIVE TEAM NAMED AS

3494
02:17:34,120 --> 02:17:34,720
INVESTIGATORS, OFT-DIFFERENT

3495
02:17:34,720 --> 02:17:37,080
APPROACHES WHERE THERE'S BEEN A

3496
02:17:37,080 --> 02:17:39,520
REQUIREMENT THAT PRINCIPAL

3497
02:17:39,520 --> 02:17:40,240
INVESTIGATORS MAY BE PAIRED,

3498
02:17:40,240 --> 02:17:47,520
MULTIPLE P.I.s, WHERE P.I.s

3499
02:17:47,520 --> 02:17:48,200
REPRESENT LEADERSHIP OF THE

3500
02:17:48,200 --> 02:17:49,920
CLINICAL SITES.

3501
02:17:49,920 --> 02:17:51,320
THIS IS SOMETHING SAID

3502
02:17:51,320 --> 02:17:54,480
FREQUENTLY IN PREVIOUS PANEL,

3503
02:17:54,480 --> 02:17:55,360
ENSURING RESEARCH QUESTIONS,

3504
02:17:55,360 --> 02:17:56,360
MILESTONES WE'RE DEVELOPING

3505
02:17:56,360 --> 02:17:58,520
AROUND TRIALS ARE MEANINGFUL TO

3506
02:17:58,520 --> 02:18:00,200
PARTNERS AT MULTIPLE LEVELS OF

3507
02:18:00,200 --> 02:18:02,280
THE ORGANIZATION OR COMMUNITY

3508
02:18:02,280 --> 02:18:04,000
SETTINGS, AND THEN POTENTIALLY

3509
02:18:04,000 --> 02:18:06,320
RESILIENT TO SOME OF THESE

3510
02:18:06,320 --> 02:18:09,280
CHANGES, THE PRIOR PANEL TALKED

3511
02:18:09,280 --> 02:18:10,760
ABOUT CONCENTRATING ON

3512
02:18:10,760 --> 02:18:13,080
IMPLEMENTATION OUTCOMES IN

3513
02:18:13,080 --> 02:18:14,400
ADDITION OR PRIMARY AROUND

3514
02:18:14,400 --> 02:18:16,800
CLINICAL OUTCOMES AS WELL, THE

3515
02:18:16,800 --> 02:18:18,160
TYPICAL EFFECTIVENESS TRIAL

3516
02:18:18,160 --> 02:18:20,120
OUTCOMES WE CONCENTRATE ON.

3517
02:18:20,120 --> 02:18:21,960
IMPORTANT WHERE WE'VE SEEN THE

3518
02:18:21,960 --> 02:18:24,680
ABILITY, THIS CAME UP AS WELL,

3519
02:18:24,680 --> 02:18:25,280
CAPTURING CONTEXTUAL DATA AS

3520
02:18:25,280 --> 02:18:27,080
PART OF THE TRIAL.

3521
02:18:27,080 --> 02:18:30,720
SO WE'RE ABLE TO TEASE APART THE

3522
02:18:30,720 --> 02:18:33,240
IMPACT OF THE CONTEXT ON TRIAL

3523
02:18:33,240 --> 02:18:35,320
IMPLEMENTATION AS WELL AS ON THE

3524
02:18:35,320 --> 02:18:37,080
EFFECTIVENESS OF OUR

3525
02:18:37,080 --> 02:18:37,840
INTERVENTIONS.

3526
02:18:37,840 --> 02:18:41,320
I THINK THE CLINICAL AND

3527
02:18:41,320 --> 02:18:42,400
INVESTIGATOR PARTNERSHIPS ENABLE

3528
02:18:42,400 --> 02:18:45,240
US TO JOINTLY PLAN FOR

3529
02:18:45,240 --> 02:18:46,560
MITIGATION STRATEGIES.

3530
02:18:46,560 --> 02:18:49,200
OUR INVESTIGATORS HAVE THOUGHT

3531
02:18:49,200 --> 02:18:52,160
ABOUT OVERSAMPLING OF SITES,

3532
02:18:52,160 --> 02:18:52,720
ANTICIPATING TRANSITIONS IN

3533
02:18:52,720 --> 02:18:54,120
LEADERSHIP, HOW DO WE MAKE SURE

3534
02:18:54,120 --> 02:18:56,080
THE SUCCESS OF STUDY ISN'T BASED

3535
02:18:56,080 --> 02:19:02,640
ON RELATIONSHIP BETWEEN JUST A

3536
02:19:02,640 --> 02:19:05,080
COUPLE FOLKS WHERE ONE MAY BE

3537
02:19:05,080 --> 02:19:06,080
HEADED FOR DIFFERENT PASTURES,

3538
02:19:06,080 --> 02:19:08,120
OTHER THINGS IN THE

3539
02:19:08,120 --> 02:19:10,080
IMPLEMENTATION SPACE AND TRIALS,

3540
02:19:10,080 --> 02:19:15,320
THE IDEA OF A PRE-MORTEM, A

3541
02:19:15,320 --> 02:19:20,800
TECHNIQUE USED IN INDUSTRY AND

3542
02:19:20,800 --> 02:19:21,480
ELSEWHERE PLANNING FOR WHAT'S

3543
02:19:21,480 --> 02:19:22,560
GOING TO GO WRONG.

3544
02:19:22,560 --> 02:19:24,960
A GROUP OF FOLKS SIT AROUND THE

3545
02:19:24,960 --> 02:19:26,520
TABLE, IDEALLY PARTNERS, BETWEEN

3546
02:19:26,520 --> 02:19:27,480
INVESTIGATORS AND CLINICAL OR

3547
02:19:27,480 --> 02:19:28,520
COMMUNITY MEMBERS, TO TRY AND

3548
02:19:28,520 --> 02:19:30,200
TALK THROUGH ALL OF THE WAYS

3549
02:19:30,200 --> 02:19:31,200
THAT THIS PARTICULAR TRIAL IS

3550
02:19:31,200 --> 02:19:33,040
NOT GOING TO WORK OUT HOW WE

3551
02:19:33,040 --> 02:19:33,280
PLANNED.

3552
02:19:33,280 --> 02:19:37,240
AND HOW DO WE TRY TO ANTICIPATE

3553
02:19:37,240 --> 02:19:39,760
THOSE IN FLEXIBLE DESIGN OR WAYS

3554
02:19:39,760 --> 02:19:41,720
IN WHICH WE SEE ALTERNATE

3555
02:19:41,720 --> 02:19:43,240
STRATEGIES FOR MOVING FORWARD.

3556
02:19:43,240 --> 02:19:45,880
THOSE ARE ALL CLINICAL OR

3557
02:19:45,880 --> 02:19:46,760
COMMUNITY SYSTEM-BASED THINGS.

3558
02:19:46,760 --> 02:19:50,120
OF COURSE, IN THIS SORT OF

3559
02:19:50,120 --> 02:19:53,000
DOMAIN OF UNEXPECTED EVENTS,

3560
02:19:53,000 --> 02:19:53,960
FIRST AND FOREMOST, COULD GET

3561
02:19:53,960 --> 02:19:56,160
MENTIONED IN RESPONSE TO EVERY

3562
02:19:56,160 --> 02:19:57,160
QUESTION, IMPORTANCE OF ENGAGING

3563
02:19:57,160 --> 02:19:59,800
WITH OUR NIH PROGRAM STAFF OR

3564
02:19:59,800 --> 02:20:00,400
GRANTS MANAGEMENT FOLKS

3565
02:20:00,400 --> 02:20:01,800
THROUGHOUT THE LIFE OF THE

3566
02:20:01,800 --> 02:20:02,280
STUDY.

3567
02:20:02,280 --> 02:20:05,800
I THINK THEY ARE THERE, WE ARE

3568
02:20:05,800 --> 02:20:06,560
THERE TO HELP INVESTIGATORS AS

3569
02:20:06,560 --> 02:20:09,080
MUCH AS WE CAN.

3570
02:20:09,080 --> 02:20:10,480
OFTEN ANSWERS TO QUESTION CAN WE

3571
02:20:10,480 --> 02:20:12,280
DO THIS OR NOT, IT DEPENDS.

3572
02:20:12,280 --> 02:20:14,480
WHAT IT DEPENDS ON OF COURSE ARE

3573
02:20:14,480 --> 02:20:16,080
OPPORTUNITY FOR EXPERTS WITHIN

3574
02:20:16,080 --> 02:20:20,800
THE NIH, EXPERTS WITHIN THE

3575
02:20:20,800 --> 02:20:22,240
INVESTIGATIVE FIELD TO TALK

3576
02:20:22,240 --> 02:20:23,960
THROUGH POTENTIAL CHALLENGES AND

3577
02:20:23,960 --> 02:20:25,520
HOW CAN WE OVERCOME THEM.

3578
02:20:25,520 --> 02:20:27,760
THERE'S BEEN AT TIMES HESITATION

3579
02:20:27,760 --> 02:20:31,200
TO ENGAGE WITH NIH STAFF FOR

3580
02:20:31,200 --> 02:20:33,280
FEAR OF SOME THINGS UNTOWARD BUT

3581
02:20:33,280 --> 02:20:34,920
AT LEAST IN MY EXPERIENCE IT'S

3582
02:20:34,920 --> 02:20:36,800
BEEN CERTAINLY THE CASE THAT THE

3583
02:20:36,800 --> 02:20:38,400
MORE ENGAGEMENT THERE IS, THE

3584
02:20:38,400 --> 02:20:41,160
MORT AWARENESS THERE ARE OF

3585
02:20:41,160 --> 02:20:43,080
PROBLEMS AS THEY OCCUR, THE

3586
02:20:43,080 --> 02:20:48,600
EASIER IT IS TO MITIGATE SOME

3587
02:20:48,600 --> 02:20:49,480
UNEXPECTED CHANGES FROM OUR NIH

3588
02:20:49,480 --> 02:20:50,680
COLLEAGUES IN THE PRIOR SECTION.

3589
02:20:50,680 --> 02:20:52,320
WE'VE SEEN IN TERMS OF

3590
02:20:52,320 --> 02:20:55,360
UNEXPECTED EVENTS JUST THE IDEA

3591
02:20:55,360 --> 02:20:59,520
HOW  FLEXIBLY WE CONSIDER DESIGN

3592
02:20:59,520 --> 02:21:00,400
AND INTERVENTIONS.

3593
02:21:00,400 --> 02:21:10,800
WE SAW TRIALS SHIFT TO

3594
02:21:11,280 --> 02:21:11,840
TELEMEDICINE, TECHNOLOGY-BASED

3595
02:21:11,840 --> 02:21:12,760
RECRUITING, WE DON'T KNOW WHAT

3596
02:21:12,760 --> 02:21:15,240
EVENTS MAY GET IN THE WAY OF OUR

3597
02:21:15,240 --> 02:21:17,360
TRIAL EFFORTS.

3598
02:21:17,360 --> 02:21:18,120
CERTAINLY MODIFICATIONS TO

3599
02:21:18,120 --> 02:21:19,760
TIMELINES, WE'VE SEEN IN THE

3600
02:21:19,760 --> 02:21:21,080
PAST WHERE THERE'S BEEN

3601
02:21:21,080 --> 02:21:22,480
REALLOCATION DEPENDING ON THE

3602
02:21:22,480 --> 02:21:25,320
KIND OF DESIGN, IF IT IS A

3603
02:21:25,320 --> 02:21:26,520
DYNAMIC WEIGHTLESS CONTROL

3604
02:21:26,520 --> 02:21:28,200
DESIGN USED, SOMETIMES THERE'S

3605
02:21:28,200 --> 02:21:29,560
BEEN REALLOCATION OF SITES TO

3606
02:21:29,560 --> 02:21:32,200
LATER COHORTS IF THEY ARE NOT

3607
02:21:32,200 --> 02:21:33,520
READY TO PARTICIPATE AT THE

3608
02:21:33,520 --> 02:21:34,880
PARTICULAR TIME THAT THEY WERE

3609
02:21:34,880 --> 02:21:36,160
FORECAST TO BE READY.

3610
02:21:36,160 --> 02:21:39,800
AND THEN I THINK ANOTHER THING

3611
02:21:39,800 --> 02:21:41,320
THAT FITS BOTH CATEGORIES THE

3612
02:21:41,320 --> 02:21:42,840
IDEA HOW WELL WE'RE IN

3613
02:21:42,840 --> 02:21:46,040
ANTICIPATE OF WHAT MIGHT HAPPEN

3614
02:21:46,040 --> 02:21:47,880
IN THE FUTURE CAPTURING

3615
02:21:47,880 --> 02:21:49,640
CONTEXTUAL DATA TO CAPTURE

3616
02:21:49,640 --> 02:21:49,880
IMPACT.

3617
02:21:49,880 --> 02:21:55,080
TO LAY THESE OUT AT DIFFERENT

3618
02:21:55,080 --> 02:21:55,880
STRATEGIES, I'VE SEEN COLLEAGUES

3619
02:21:55,880 --> 02:21:58,840
AT THE NIH USE TO BOTH

3620
02:21:58,840 --> 02:22:00,040
ANTICIPATE WHAT MIGHT HAPPEN AND

3621
02:22:00,040 --> 02:22:03,120
THEN COPE WITH IT AS IT IS

3622
02:22:03,120 --> 02:22:03,520
HAPPENING.

3623
02:22:03,520 --> 02:22:05,240
WITH THAT I'LL PAUSE AND LOOK

3624
02:22:05,240 --> 02:22:07,080
FORWARD TO THE CONVERSATION.

3625
02:22:07,080 --> 02:22:13,120
QUICK COMMENTS FROM ANY OF THE

3626
02:22:13,120 --> 02:22:18,600
OTHER PANELISTS? 

3627
02:22:18,600 --> 02:22:18,880
OKAY.

3628
02:22:18,880 --> 02:22:24,040
THEN WYNNE, TAKE THE BATON.

3629
02:22:24,040 --> 02:22:26,920
>> I THINK THERE WAS A
COMMENT.

3630
02:22:26,920 --> 02:22:30,400
>> I CAN JUST COMMENT
QUICKLY,

3631
02:22:30,400 --> 02:22:31,680
RICH, I APPRECIATED COMMENTS

3632
02:22:31,680 --> 02:22:35,960
ABOUT PARTNERSHIP AND WE'VE HAD

3633
02:22:35,960 --> 02:22:38,280
A TEN-YEAR PARTNERSHIP WITH RICH

3634
02:22:38,280 --> 02:22:41,680
PLATT'S GROUP, THAT'S REALLY

3635
02:22:41,680 --> 02:22:45,920
HELPED UNDERSTAND PER  PERSPECTS

3636
02:22:45,920 --> 02:22:48,320
THAT CAN BE DIFFERENT BUT WE

3637
02:22:48,320 --> 02:22:50,240
UNDERSTAND THEM, THAT ALLOWS FOR

3638
02:22:50,240 --> 02:22:50,600
SUCCESS.

3639
02:22:50,600 --> 02:22:56,080
I THINK THE OTHER ISSUE THAT

3640
02:22:56,080 --> 02:22:57,720
RESONATED IS THE ANTICIPATING OF

3641
02:22:57,720 --> 02:22:58,920
CHANGES AND JUST ONE THING THAT

3642
02:22:58,920 --> 02:23:01,600
COMES TO MIND, FOR EXAMPLE, IN

3643
02:23:01,600 --> 02:23:04,960
OUR STUDIES WHICH INVOLVES

3644
02:23:04,960 --> 02:23:06,720
MULTIPLE INSTITUTIONS IS YOU CAN

3645
02:23:06,720 --> 02:23:11,720
HAVE AN ENTIRE INSTITUTION DROP

3646
02:23:11,720 --> 02:23:14,600
OUT FOR UNFORESEEN REASONS LIKE,

3647
02:23:14,600 --> 02:23:17,560
YOU KNOW, THEY CHANGED THEIR

3648
02:23:17,560 --> 02:23:21,040
ELECTRONIC EMR OR THEY ARE SOLD

3649
02:23:21,040 --> 02:23:24,680
TO ANOTHER ORGANIZATION, AND

3650
02:23:24,680 --> 02:23:26,080
THOSE ARE INEVITABLE AND THE

3651
02:23:26,080 --> 02:23:29,240
KINDS OF THINGS WE'VE LEARNED TO

3652
02:23:29,240 --> 02:23:33,000
ANTICIPATE AS PART OF THE

3653
02:23:33,000 --> 02:23:33,600
INITIAL DESIGNS.

3654
02:23:33,600 --> 02:23:34,080
>> OKAY.

3655
02:23:34,080 --> 02:23:37,280
ED, DO YOU WANT TO COMMENT?

3656
02:23:37,280 --> 02:23:38,920
>> YEAH, TO PIGGYBACK,
ANOTHER

3657
02:23:38,920 --> 02:23:40,240
THING WE'VE DONE IN OUR DESIGNS

3658
02:23:40,240 --> 02:23:43,640
IS MADE SURE WE HAD THE RIGHT

3659
02:23:43,640 --> 02:23:45,360
STAKEHOLDERS AROUND THE TABLE.

3660
02:23:45,360 --> 02:23:46,560
SO IT'S IMPORTANT BECAUSE THEY

3661
02:23:46,560 --> 02:23:48,960
ARE THE ONES THAT WILL BE

3662
02:23:48,960 --> 02:23:51,160
EXECUTING THE INTERVENTION.

3663
02:23:51,160 --> 02:23:52,800
SO FOR INSTANCE FOR A BABY WE

3664
02:23:52,800 --> 02:23:55,320
WANT TO MAKE SURE WE HAD NURSING

3665
02:23:55,320 --> 02:23:58,960
AROUND THE TABLE, THE ONES DOING

3666
02:23:58,960 --> 02:24:03,520
THE BATHING, WE WANT PHARMACY

3667
02:24:03,520 --> 02:24:06,280
AROUND THE TABLE TO TRACK, WE

3668
02:24:06,280 --> 02:24:07,800
WANT OUR BETA SCIENTISTS AROUND

3669
02:24:07,800 --> 02:24:18,240
THE TABLE BECAUSE THEY DO

3670
02:24:21,680 --> 02:24:23,360
REPORTS FOR US.

3671
02:24:23,360 --> 02:24:25,800
WE TRY TO TRACK ADHERENCE,

3672
02:24:25,800 --> 02:24:29,800
THAT'S OUR GUIDE, HOW WELL ARE

3673
02:24:29,800 --> 02:24:31,680
WE DOING CHT ABATING FOR ABATE

3674
02:24:31,680 --> 02:24:34,520
TRIAL, TRACK THAT, IF WE SEE

3675
02:24:34,520 --> 02:24:36,400
SYSTEMS OR ORGANIZATIONS OR

3676
02:24:36,400 --> 02:24:37,480
HOSPITALS ARE LAGGING, WE TRY TO

3677
02:24:37,480 --> 02:24:43,360
ADDRESS THAT ON THE FLY.

3678
02:24:43,360 --> 02:24:43,880
>> NATALIA?

3679
02:24:43,880 --> 02:24:44,840
>> HI.

3680
02:24:44,840 --> 02:24:47,960
YEAH, I JUST WANTED TO MAKE ONE

3681
02:24:47,960 --> 02:24:50,080
COMMENT ON THE OUTCOMES

3682
02:24:50,080 --> 02:24:53,160
MEANINGFUL TO MULTIPLE PARTNERS.

3683
02:24:53,160 --> 02:24:55,240
I THOUGHT THAT WAS INTERESTING

3684
02:24:55,240 --> 02:24:59,600
THAT SHOWED UP FOR THE OPTIMUM

3685
02:24:59,600 --> 02:25:02,640
STUDY, WE ADOPTED THE PAY AS A

3686
02:25:02,640 --> 02:25:04,640
RECOMMENDATION BY THE STUDY

3687
02:25:04,640 --> 02:25:07,480
SECTION FOR MAIN OUTCOME

3688
02:25:07,480 --> 02:25:11,640
MEASURE, PAY IS

3689
02:25:11,640 --> 02:25:12,280
MULTI-DIMENSIONAL ASSESSMENT OF

3690
02:25:12,280 --> 02:25:18,280
PAIN, WHAT I LIKE, IT DOES HAVE

3691
02:25:18,280 --> 02:25:19,920
WIDESPREAD ADOPTION ACROSS

3692
02:25:19,920 --> 02:25:21,480
MULTIPLE PARTNERS, CDC

3693
02:25:21,480 --> 02:25:23,000
RECOMMENDS IT, IT'S RECOMMENDED

3694
02:25:23,000 --> 02:25:25,320
IN PRIMARY CARE, IT'S IN THE

3695
02:25:25,320 --> 02:25:26,960
ELECTRONIC HEALTH RECORDS, IT'S

3696
02:25:26,960 --> 02:25:33,080
EASY FOR PARTICIPANTS IN A STUDY

3697
02:25:33,080 --> 02:25:35,400
TO ANSWER IT, SO I THINK -- I

3698
02:25:35,400 --> 02:25:37,560
WANTED TO UNDERSTORE THAT WHEN

3699
02:25:37,560 --> 02:25:39,120
THE OUTCOME IS MEANINGFUL TO

3700
02:25:39,120 --> 02:25:40,520
MULTIPLE PARTNERS, IT'S GOING TO

3701
02:25:40,520 --> 02:25:44,880
BE EASIER TO MOVE FORWARD TO

3702
02:25:44,880 --> 02:25:52,560
THAT NEXT STEP OF

3703
02:25:52,560 --> 02:25:52,920
IMPLEMENTATION.

3704
02:25:52,920 --> 02:25:53,200
>> OKAY.

3705
02:25:53,200 --> 02:25:55,520
WYNNE, NICE TO SEE YOU ON

3706
02:25:55,520 --> 02:25:55,720
CAMERA.

3707
02:25:55,720 --> 02:25:58,360
>> NICE TO SEE YOU AS
WELL.

3708
02:25:58,360 --> 02:26:00,560
GOOD AFTERNOON, GOOD MORNING, OR

3709
02:26:00,560 --> 02:26:05,160
EVENING, WHEREVER FORCE  -- FOLE

3710
02:26:05,160 --> 02:26:05,600
JOINING TEAM.

3711
02:26:05,600 --> 02:26:07,360
I WANT TO NOTE BEFORE I START

3712
02:26:07,360 --> 02:26:09,600
THANK YOU VERY MUCH FOR THE

3713
02:26:09,600 --> 02:26:15,640
OPPORTUNITY TO BE PART OF THIS

3714
02:26:15,640 --> 02:26:16,840
PANEL, A THOUGHTFUL KIND OF YOU

3715
02:26:16,840 --> 02:26:20,040
TO ASK ME.

3716
02:26:20,040 --> 02:26:21,440
APPRECIATE YOUR COMMENTS ABOUT

3717
02:26:21,440 --> 02:26:22,360
LEADING THE EFFORTS.

3718
02:26:22,360 --> 02:26:25,120
HE SETS THE BAR HIGH FOR THESE

3719
02:26:25,120 --> 02:26:25,720
PANELS.

3720
02:26:25,720 --> 02:26:32,560
NEXT TIME I'LL TRY  TO GO BEFORE

3721
02:26:32,560 --> 02:26:34,560
VERSUS AFTER, I APPRECIATE BEING

3722
02:26:34,560 --> 02:26:35,560
INVITED TO CHAT.

3723
02:26:35,560 --> 02:26:38,160
I WANTED TO SHARE THOUGHTS TODAY

3724
02:26:38,160 --> 02:26:40,440
AROUND REALLY FOCUSING IN MORE

3725
02:26:40,440 --> 02:26:43,960
ON THE FIRST PHASE, UG3 PHASE

3726
02:26:43,960 --> 02:26:45,040
VERSUS UH3 PHASE, ALTHOUGH

3727
02:26:45,040 --> 02:26:46,840
RECOGNIZING THERE ARE SOME

3728
02:26:46,840 --> 02:26:47,520
DIFFERENT TERMINOLOGY HERE SO

3729
02:26:47,520 --> 02:26:49,960
I'LL REFER TO IT AS THE FIRST

3730
02:26:49,960 --> 02:26:50,160
PHASE.

3731
02:26:50,160 --> 02:26:52,840
WHAT COULD BE DONE DURING THE

3732
02:26:52,840 --> 02:26:54,120
FIRST PHASE, WHICH ALSO IS A

3733
02:26:54,120 --> 02:26:57,200
PRODUCT OF WHAT IS PROPOSED IN

3734
02:26:57,200 --> 02:26:58,920
THE GRANT, THAT COULD TRY TO

3735
02:26:58,920 --> 02:27:00,720
MITIGATE SOME OF THE CHALLENGES

3736
02:27:00,720 --> 02:27:02,320
THAT HAVE BEEN DISCUSSED

3737
02:27:02,320 --> 02:27:04,760
YESTERDAY AND TODAY AROUND

3738
02:27:04,760 --> 02:27:05,960
RECRUITMENT IN PARTICULAR.

3739
02:27:05,960 --> 02:27:08,480
AND SO REALLY TRYING TO THINK

3740
02:27:08,480 --> 02:27:10,120
ABOUT AND IT'S A PATE MOST

3741
02:27:10,120 --> 02:27:12,400
TRIALS I WOULD SAY HAVE

3742
02:27:12,400 --> 02:27:13,520
CHALLENGES WITH RECRUITMENT AND

3743
02:27:13,520 --> 02:27:14,840
ACTUALLY THAT'S ONE OF THE

3744
02:27:14,840 --> 02:27:18,200
REASONS MOST TRIALS ARE SHUT

3745
02:27:18,200 --> 02:27:19,760
DOWN EARLY.

3746
02:27:19,760 --> 02:27:21,200
ALSO KIND OF DOVETAIL INTO,

3747
02:27:21,200 --> 02:27:22,480
RICH, WHAT YOU WERE TALKING

3748
02:27:22,480 --> 02:27:25,800
ABOUT IN TERMS OF PILOT TESTING

3749
02:27:25,800 --> 02:27:28,080
THE INTERVENTION AND HOW MUCH

3750
02:27:28,080 --> 02:27:29,280
CHANGE IS APPROPRIATE AND

3751
02:27:29,280 --> 02:27:33,120
NECESSARY, WHAT THAT MEANS FOR

3752
02:27:33,120 --> 02:27:33,920
THE PROTOCOL.

3753
02:27:33,920 --> 02:27:35,640
SO, WANTED TO OF COURSE

3754
02:27:35,640 --> 02:27:37,840
RECOGNIZE THAT IN YOUR

3755
02:27:37,840 --> 02:27:39,560
APPLICATION OR IN APPLICATIONS

3756
02:27:39,560 --> 02:27:41,440
FOLKS OBVIOUSLY ENGAGE THEIR

3757
02:27:41,440 --> 02:27:42,840
STATISTICIAN, ACTUALLY AS IT'S

3758
02:27:42,840 --> 02:27:45,960
BEEN MENTIONED ENGAGE THEIR

3759
02:27:45,960 --> 02:27:48,800
PARTNERS, WHETHER CRITICAL

3760
02:27:48,800 --> 02:27:49,560
PARTNERS, PATIENT

3761
02:27:49,560 --> 02:27:50,280
REPRESENTATIVES, DIFFERENT

3762
02:27:50,280 --> 02:27:52,400
LEADERS IN THE C-SUITE FOR

3763
02:27:52,400 --> 02:27:57,440
DIFFERENT CLINICS AND HEALTH

3764
02:27:57,440 --> 02:27:58,520
SYSTEMS, TO THINK ABOUT ISSUES

3765
02:27:58,520 --> 02:28:00,480
THAT MIGHT COME UP AND THE WAYS

3766
02:28:00,480 --> 02:28:02,320
IN WHICH THINGS MIGHT GO WRONG

3767
02:28:02,320 --> 02:28:06,080
AND HOW MUCH AND TO WHAT EXTENT

3768
02:28:06,080 --> 02:28:10,800
ONE MIGHT NEED TO OVERSAMPLE AND

3769
02:28:10,800 --> 02:28:13,200
PLANNED FOR THOSE.

3770
02:28:13,200 --> 02:28:14,840
WE'RE IN PRAGMATIC TRIALS

3771
02:28:14,840 --> 02:28:15,720
FOCUSED ON QUESTIONS IMPORTANT

3772
02:28:15,720 --> 02:28:20,560
TO DECISION MAKERS AND RESEARCH

3773
02:28:20,560 --> 02:28:21,520
PARTNERS, QUITE A CHALLENGE

3774
02:28:21,520 --> 02:28:24,160
REGARDLESS OF THE TYPE OF TRIAL

3775
02:28:24,160 --> 02:28:27,520
AND YOU HAVE THOSE FOLKS ENGAGED

3776
02:28:27,520 --> 02:28:32,720
IDEALLY BUT THINGS CAN GO

3777
02:28:32,720 --> 02:28:33,440
SIDEWAYS HERE.

3778
02:28:33,440 --> 02:28:35,400
I WANTED TO SPLIT IN THINGS THAT

3779
02:28:35,400 --> 02:28:38,480
COULD BE DONE BEFORE THE FULL

3780
02:28:38,480 --> 02:28:40,240
TRIAL IS LAUNCHED IN THE SECOND

3781
02:28:40,240 --> 02:28:41,520
PHASE AND THINGS THAT COULD BE

3782
02:28:41,520 --> 02:28:43,360
TRIED WITHIN THE FIRST PHASE TO

3783
02:28:43,360 --> 02:28:45,720
TRY AND PREVENT THAT FROM

3784
02:28:45,720 --> 02:28:47,360
HAPPENING OR LIMIT THE EFFECT IT

3785
02:28:47,360 --> 02:28:49,400
HAS ON MOVING THE TRIAL FORWARD

3786
02:28:49,400 --> 02:28:52,680
IN THAT SECOND PHASE.

3787
02:28:52,680 --> 02:28:56,600
OF COURSE, NUMBERS,

3788
02:28:56,600 --> 02:28:57,200
REPRESENTATIVENESS, REESSENTIAL

3789
02:28:57,200 --> 02:28:58,600
IN THE STUDY.

3790
02:28:58,600 --> 02:29:02,520
WE TALKED ABOUT PATIENT CENTERED

3791
02:29:02,520 --> 02:29:03,960
RESEARCH IN PCORI, BROUGHT UP

3792
02:29:03,960 --> 02:29:05,160
INCLUDING TWO REPRESENTATIVES ON

3793
02:29:05,160 --> 02:29:07,880
REVIEW, WE ALSO TALK ABOUT

3794
02:29:07,880 --> 02:29:08,760
PRACTITIONER-CENTERED RESEARCH.

3795
02:29:08,760 --> 02:29:11,160
TO WHAT EXTENT IS THIS TRIAL

3796
02:29:11,160 --> 02:29:11,920
ANSWERING A QUESTION OR

3797
02:29:11,920 --> 02:29:14,320
QUESTIONS THAT ARE IMPORTANT TO

3798
02:29:14,320 --> 02:29:15,320
PRACTITIONERS, WHETHER IT BE

3799
02:29:15,320 --> 02:29:17,520
SOMETHING THAT HELPS THEM DO

3800
02:29:17,520 --> 02:29:20,600
THEIR WORK BETTER, WHETHER IT BE

3801
02:29:20,600 --> 02:29:21,760
SOMETHING MORE EFFICIENT,

3802
02:29:21,760 --> 02:29:24,080
RESPONSIVE TO PATIENT NEEDS,

3803
02:29:24,080 --> 02:29:28,160
DOES IT REFLECT PERHAPS CURRENT

3804
02:29:28,160 --> 02:29:30,440
OR FORTHCOMING POLICY CHANGES,

3805
02:29:30,440 --> 02:29:32,520
TRYING TO BLEND THAT WITH

3806
02:29:32,520 --> 02:29:34,400
ADVANCING THE SCIENCE, ADVANCING

3807
02:29:34,400 --> 02:29:38,000
RESEARCH IN THIS PARTICULAR

3808
02:29:38,000 --> 02:29:38,320
AREA.

3809
02:29:38,320 --> 02:29:40,160
ENGAGE WITH STAKEHOLDERS EARLY

3810
02:29:40,160 --> 02:29:41,600
ON, WHAT ARE THE REASONABLE

3811
02:29:41,600 --> 02:29:44,960
NUMBERS, WORKING WITH YOUR

3812
02:29:44,960 --> 02:29:45,680
STATISTICIAN AND METHODOLOGISTS,

3813
02:29:45,680 --> 02:29:48,280
TRYING TO CONSIDER WHAT MIGHT BE

3814
02:29:48,280 --> 02:29:52,240
SOME SOLVENT STRATEGIES, SO TO

3815
02:29:52,240 --> 02:29:54,840
SPEAK, MIGHT YOU NEED TO EXPAND

3816
02:29:54,840 --> 02:29:56,280
ELIGIBILITY, TO ANALYZE PROVIDER

3817
02:29:56,280 --> 02:29:57,680
VERSUS CLINIC LEVEL WHICH HAS

3818
02:29:57,680 --> 02:29:59,560
BEEN DONE IN SOME TRIALS,

3819
02:29:59,560 --> 02:30:03,160
BECAUSE YOU DON'T HAVE ENOUGH

3820
02:30:03,160 --> 02:30:03,920
CLINICS.

3821
02:30:03,920 --> 02:30:07,040
ANOTHER ISSUE I THINK THAT ONE

3822
02:30:07,040 --> 02:30:08,040
COULD CONSIDER IS HOW MUCH

3823
02:30:08,040 --> 02:30:10,720
EFFORT DO YOU WANT TO PUT INTO

3824
02:30:10,720 --> 02:30:11,120
RECRUITMENT.

3825
02:30:11,120 --> 02:30:13,320
CERTAINLY YOU WANT TO MAXIMIZE

3826
02:30:13,320 --> 02:30:15,000
YOUR ABILITY TO RECRUIT PATIENTS

3827
02:30:15,000 --> 02:30:16,080
INTO THE TRIAL, OTHERWISE YOU

3828
02:30:16,080 --> 02:30:18,040
WON'T BE ABLE TO CONDUCT THE

3829
02:30:18,040 --> 02:30:22,720
TRIAL, BUT BALANCING THIS WITH

3830
02:30:22,720 --> 02:30:25,120
IF WE LOOK BACK AT THE

3831
02:30:25,120 --> 02:30:28,160
RECRUITMENT DOMAIN AND

3832
02:30:28,160 --> 02:30:29,400
ELIGIBILITY DOMAIN.

3833
02:30:29,400 --> 02:30:31,520
HOW MUCH EFFORT YOU PUT INTO

3834
02:30:31,520 --> 02:30:32,600
RECRUITMENT WOULD BE A FUNCTION

3835
02:30:32,600 --> 02:30:34,680
TO WHETHER THE TRIAL MORE OR

3836
02:30:34,680 --> 02:30:36,400
LESS PRAGMATIC WITHIN THAT

3837
02:30:36,400 --> 02:30:37,200
PARTICULAR DOMAIN.

3838
02:30:37,200 --> 02:30:40,680
THERE ARE PROS OF INCREASING THE

3839
02:30:40,680 --> 02:30:44,440
AMOUNT OF EFFORT ONE USES FOR

3840
02:30:44,440 --> 02:30:45,200
ENHANCING RECRUITMENT BUT

3841
02:30:45,200 --> 02:30:46,840
CERTAINLY CONS AS WELL TO THE

3842
02:30:46,840 --> 02:30:49,120
EXTENT THAT MAY BIAS THE TRIAL

3843
02:30:49,120 --> 02:30:50,800
MORE TOWARD THE EXPLANATORY END

3844
02:30:50,800 --> 02:30:53,920
FOR THAT DOMAIN RATHER THAN THE

3845
02:30:53,920 --> 02:30:54,600
PRAGMATIC END.

3846
02:30:54,600 --> 02:30:56,400
AND ALSO CERTAINLY BRINGS UP

3847
02:30:56,400 --> 02:30:58,520
QUESTIONS AROUND IF YOU CAN'T

3848
02:30:58,520 --> 02:31:00,400
RECRUIT, WHAT DOES THAT SAY

3849
02:31:00,400 --> 02:31:02,360
ABOUT THE QUESTION, WHAT DOES

3850
02:31:02,360 --> 02:31:04,360
THAT SAY ABOUT THE STRUCTURE,

3851
02:31:04,360 --> 02:31:10,120
AND REALLY LEANING MORE TOWARD

3852
02:31:10,120 --> 02:31:11,560
THE EXPLANATORY END, TO THAT

3853
02:31:11,560 --> 02:31:12,360
DOMAIN, IS THIS SOMETHING THAT

3854
02:31:12,360 --> 02:31:16,920
SHOULD BE DONE IN THE  FIRST

3855
02:31:16,920 --> 02:31:19,240
PLACE, IMPLICATIONS FOR THE

3856
02:31:19,240 --> 02:31:22,920
TRIAL OVERALL. 

3857
02:31:22,920 --> 02:31:24,080
SOME POTENTIAL SOLUTIONS TRYING

3858
02:31:24,080 --> 02:31:26,040
TO MITIGATE CHALLENGES IN THE

3859
02:31:26,040 --> 02:31:28,440
SECOND PHASE AROUND RECRUITMENT

3860
02:31:28,440 --> 02:31:29,560
AND PARTICIPATION AND ENGAGEMENT

3861
02:31:29,560 --> 02:31:33,040
IN TRIALS I THINK ONE OF THE

3862
02:31:33,040 --> 02:31:34,480
FIRST CONSIDERATIONS COULD BE

3863
02:31:34,480 --> 02:31:36,360
LOOKING TO THE LITERATURE.

3864
02:31:36,360 --> 02:31:37,960
SO THERE'S A BURGEONING

3865
02:31:37,960 --> 02:31:39,600
LITERATURE ON TRIAL ENGAGEMENT

3866
02:31:39,600 --> 02:31:41,160
AND PARTICIPATION, TRYING TO

3867
02:31:41,160 --> 02:31:43,320
BETTER UNDERSTAND WHO AND HOW

3868
02:31:43,320 --> 02:31:45,200
AND WHY FOLKS DO AND DO NOT

3869
02:31:45,200 --> 02:31:46,160
PARTICIPATE IN TRIALS.

3870
02:31:46,160 --> 02:31:48,880
SOME OF THE RECENT WORK WE'VE

3871
02:31:48,880 --> 02:31:56,560
DONE AT NCI IS USING THE HEALTH

3872
02:31:56,560 --> 02:31:59,520
INFORMATION, NATIONAL TREND

3873
02:31:59,520 --> 02:32:02,520
SURVEY, A REGULARLY -- SURVEY

3874
02:32:02,520 --> 02:32:03,120
COLLECT, NATIONAL REPRESENTED

3875
02:32:03,120 --> 02:32:05,000
DATA IN THE U.S.

3876
02:32:05,000 --> 02:32:06,440
WE FOUND THERE'S SOME RESEARCH

3877
02:32:06,440 --> 02:32:07,760
INDICATING THAT BLACKS ARE

3878
02:32:07,760 --> 02:32:10,800
ACTUALLY MORE LIKELY TO BE

3879
02:32:10,800 --> 02:32:11,760
OFFERED TO PARTICIPATE IN

3880
02:32:11,760 --> 02:32:12,880
CLINICAL TRIALS THAN WHITES BUT

3881
02:32:12,880 --> 02:32:14,960
ARE LESS LIKELY TO ACTUALLY

3882
02:32:14,960 --> 02:32:16,280
PARTICIPATE WHICH IS PROBABLY NO

3883
02:32:16,280 --> 02:32:17,240
SURPRISE TO FOLKS.

3884
02:32:17,240 --> 02:32:18,480
SO WHERE IS THE BREAKDOWN?

3885
02:32:18,480 --> 02:32:21,200
WHAT ARE SOME OF THE BARRIERS

3886
02:32:21,200 --> 02:32:22,760
TOWARD PARTICIPATING IN CLINICAL

3887
02:32:22,760 --> 02:32:23,760
TRIALS?

3888
02:32:23,760 --> 02:32:24,920
WHAT ARE SOME FACILITATORS, IS

3889
02:32:24,920 --> 02:32:26,800
IT FINANCIAL, IS IT OTHER

3890
02:32:26,800 --> 02:32:29,200
INCENTIVES SUCH AS CHILD CARE,

3891
02:32:29,200 --> 02:32:34,120
IS IT MORE EFFICIENCY IN TERMS

3892
02:32:34,120 --> 02:32:35,680
OF RECRUITMENT AND CONSENT WHICH

3893
02:32:35,680 --> 02:32:42,480
HAS BEEN DONE DURING COVID THAT

3894
02:32:42,480 --> 02:32:43,640
ARE VIRTUAL AND TELEHEALTH BASED

3895
02:32:43,640 --> 02:32:46,600
RATHER THAN IN PERSON, ARE THERE

3896
02:32:46,600 --> 02:32:48,240
STRATEGIES THAT COULD ENHANCE

3897
02:32:48,240 --> 02:32:50,840
UNDERSTANDING OF TRIALS AS A WAY

3898
02:32:50,840 --> 02:32:54,600
TO TRY TO EMPHASIZE AND INCREASE

3899
02:32:54,600 --> 02:32:56,880
PARTICIPATION IN TRIALS, SO

3900
02:32:56,880 --> 02:32:58,440
THAT'S ONE ASPECT LOOKING TO THE

3901
02:32:58,440 --> 02:33:00,800
LITERATURE IN TERMS OF BETTER

3902
02:33:00,800 --> 02:33:01,600
UNDERSTANDING OF COURSE,

3903
02:33:01,600 --> 02:33:04,240
CONTRIBUTING TO THE LITERATURE

3904
02:33:04,240 --> 02:33:07,080
AS THESE TRIALS UNFOLD.

3905
02:33:07,080 --> 02:33:10,480
TO THIS END, AS HAS ALSO BEEN

3906
02:33:10,480 --> 02:33:11,360
BROUGHT UP, WE'VE CONSIDERED AT

3907
02:33:11,360 --> 02:33:15,080
THE NCI AND HAVE EXPERIENCE WITH

3908
02:33:15,080 --> 02:33:15,840
UG3/UH3 PHASE IN INTERNAL

3909
02:33:15,840 --> 02:33:19,120
DISCUSSIONS AS WELL AS

3910
02:33:19,120 --> 02:33:20,200
DISCUSSIONS EXTERNALLY WITH

3911
02:33:20,200 --> 02:33:21,400
OTHER NIH COLLEAGUES, AND AS

3912
02:33:21,400 --> 02:33:23,160
WE'VE SEEN SOME OF THESE

3913
02:33:23,160 --> 02:33:26,040
DIFFERENT TRIALS UNFOLD USING

3914
02:33:26,040 --> 02:33:28,120
THIS PHASED APPROACH WE RECENTLY

3915
02:33:28,120 --> 02:33:32,160
ISSUED A PAR ON PRAGMATIC TRIALS

3916
02:33:32,160 --> 02:33:37,080
FOR OUR DIVISION, SOME MORE

3917
02:33:37,080 --> 02:33:38,160
CANCER, BEHAVIOR, EPIDEMIOLOGY,

3918
02:33:38,160 --> 02:33:40,040
SURVIVE RESEARCH TYPE OF TRIALS

3919
02:33:40,040 --> 02:33:41,800
AND DECIDED TO INCREASE OR

3920
02:33:41,800 --> 02:33:43,640
EXPAND FROM ONE YEAR FOR THE

3921
02:33:43,640 --> 02:33:46,080
FIRST PHASE TO A MAX OF TWO

3922
02:33:46,080 --> 02:33:46,560
YEARS.

3923
02:33:46,560 --> 02:33:49,040
REALLY SAW THIS AS AN

3924
02:33:49,040 --> 02:33:50,720
OPPORTUNITY AGAIN TO REFINE AND

3925
02:33:50,720 --> 02:33:52,920
HONE STUDY DESIGN AND

3926
02:33:52,920 --> 02:33:54,400
IMPLEMENTATION OF THE TRIAL,

3927
02:33:54,400 --> 02:33:57,480
WHICH WOULD ALSO THEN LEND

3928
02:33:57,480 --> 02:34:00,120
ITSELF TO IDEALLY AS WE'VE

3929
02:34:00,120 --> 02:34:01,560
SPECIFIED NOT ONLY ADAPTING AND

3930
02:34:01,560 --> 02:34:03,280
REFINING THE INTERVENTION AS

3931
02:34:03,280 --> 02:34:04,600
RICH WAS MENTIONING, AS FOLKS

3932
02:34:04,600 --> 02:34:08,320
WERE TALKING ABOUT HOW MUCH

3933
02:34:08,320 --> 02:34:10,640
ADAPTATION AND HOW MUCH IS

3934
02:34:10,640 --> 02:34:12,480
NECESSARY OR WOULD BE NEEDED FOR

3935
02:34:12,480 --> 02:34:14,920
THE TRIAL AND CAN YOU

3936
02:34:14,920 --> 02:34:16,320
ANTICIPATE, AND PILOT THAT

3937
02:34:16,320 --> 02:34:17,400
DURING THOSE TWO YEARS, IF YOU

3938
02:34:17,400 --> 02:34:20,240
OPT FOR UP TO THE TWO YEARS, BUT

3939
02:34:20,240 --> 02:34:24,280
ALSO KIND OF THE OPPORTUNITY AS

3940
02:34:24,280 --> 02:34:26,280
WAS ALSO WAS DISCUSSED AROUND

3941
02:34:26,280 --> 02:34:27,680
CYCLES, THE OPPORTUNITY TO

3942
02:34:27,680 --> 02:34:30,640
CONDUCT SMALL RAPID CYCLE

3943
02:34:30,640 --> 02:34:32,640
STUDIES WITHIN THE UG3 PHASE.

3944
02:34:32,640 --> 02:34:34,800
AND NCI HOSTED A WORKSHOP LAST

3945
02:34:34,800 --> 02:34:39,160
YEAR ON RAPID CYCLE RESEARCH

3946
02:34:39,160 --> 02:34:40,520
WHICH INCLUDED AMY KILBORN,

3947
02:34:40,520 --> 02:34:42,680
TALKED ABOUT HER WORK YESTERDAY,

3948
02:34:42,680 --> 02:34:45,160
APPLIED TO RECRUITMENT PHASE AND

3949
02:34:45,160 --> 02:34:45,480
OPTIMIZATION.

3950
02:34:45,480 --> 02:34:46,720
THERE'S ONE PARTICULAR STUDY

3951
02:34:46,720 --> 02:34:48,920
DESIGN THAT COMES FROM OUR

3952
02:34:48,920 --> 02:34:50,760
COLLEAGUES AT TRIAL FORGE IN THE

3953
02:34:50,760 --> 02:34:52,760
U.K. WHICH ARE CALLED SWAPS.

3954
02:34:52,760 --> 02:34:55,240
STUDIES WITHIN A TRIAL.

3955
02:34:55,240 --> 02:34:56,840
AND THESE ARE SELF-CONTAINED

3956
02:34:56,840 --> 02:34:58,560
RESEARCH STUDY EMBEDDED IN A

3957
02:34:58,560 --> 02:35:00,400
HOST TRIAL TO EVALUATE OR

3958
02:35:00,400 --> 02:35:02,400
EXPLORE ALTERNATIVE WAYS OF

3959
02:35:02,400 --> 02:35:04,000
DELIVERING OR ORGANIZING A

3960
02:35:04,000 --> 02:35:06,480
PARTICULAR TRIAL PROCESS.

3961
02:35:06,480 --> 02:35:07,600
IT'S A FORMAL DEFINITION.

3962
02:35:07,600 --> 02:35:10,240
IN PRACTICE ARE THERE WAYS TO

3963
02:35:10,240 --> 02:35:12,400
IMPROVE EFFICIENCY OF THE

3964
02:35:12,400 --> 02:35:13,480
CONDUCT OF A TRIAL, INCLUDING

3965
02:35:13,480 --> 02:35:15,720
BUT NOT LIMITED TO TESTING

3966
02:35:15,720 --> 02:35:18,040
DIFFERENT RECRUITMENT STRATEGIES

3967
02:35:18,040 --> 02:35:21,200
IN THAT FIRST PHASE, IN-PERSON

3968
02:35:21,200 --> 02:35:22,920
PLUS E-MAIL RECRUITMENT MORE

3969
02:35:22,920 --> 02:35:27,760
EFFECTIVE VERSE  U.S. -- VERSUS

3970
02:35:27,760 --> 02:35:30,560
IN-PERSON ALONE?

3971
02:35:30,560 --> 02:35:40,800
PHONE CALL PLUS E-MAIL PLUS IN

3972
02:35:40,800 --> 02:35:41,040
PERSON?

3973
02:35:41,040 --> 02:35:43,200
IT'S AN OPPORTUNITY TO LOOK AT

3974
02:35:43,200 --> 02:35:47,080
RECRUITMENT IN TERMS OF NOT AT

3975
02:35:47,080 --> 02:35:49,760
THE PATIENT LEVEL BUT AT THE

3976
02:35:49,760 --> 02:35:50,640
PARTICIPANT LEVEL, PRACTITIONERS

3977
02:35:50,640 --> 02:35:53,920
OR CLINICS SO WE'VE DONE SOME

3978
02:35:53,920 --> 02:35:55,520
WORK TRYING TO EXPAND THIS TO

3979
02:35:55,520 --> 02:35:57,640
TRIALS THAT ARE TESTING

3980
02:35:57,640 --> 02:35:58,280
IMPLEMENTATION STRATEGIES, AND

3981
02:35:58,280 --> 02:36:02,760
WAYS IN WHICH YOU MIGHT BE ABLE

3982
02:36:02,760 --> 02:36:06,800
TO EMBED A SWAP, NOT JUST

3983
02:36:06,800 --> 02:36:07,600
PATIENTS AS PARTICIPANTS BUT

3984
02:36:07,600 --> 02:36:10,760
ALSO OR INSTEAD OF JUST LOOKING

3985
02:36:10,760 --> 02:36:13,040
AT PRACTITIONERS OR CLINICS,

3986
02:36:13,040 --> 02:36:16,120
ORGANIZATIONS, WHO ARE THE

3987
02:36:16,120 --> 02:36:17,960
PARTICIPANTS IN THAT TRIAL.

3988
02:36:17,960 --> 02:36:20,360
LAST, REALLY TRYING TO CONTINUE

3989
02:36:20,360 --> 02:36:22,560
TO BUILD CAPACITY INTERNALLY AND

3990
02:36:22,560 --> 02:36:23,320
EXTERNALLY IN CONDUCTING

3991
02:36:23,320 --> 02:36:24,960
PRAGMATIC TRIALS AND ALL THE

3992
02:36:24,960 --> 02:36:27,120
WONDERFUL WORK THAT YOU HAVE

3993
02:36:27,120 --> 02:36:35,160
DONE AND LIVERING TEXT BOOK AND

3994
02:36:35,160 --> 02:36:36,120
SO MUCH RICH INFORMATION

3995
02:36:36,120 --> 02:36:36,880
COLLECTED AND SHARED.

3996
02:36:36,880 --> 02:36:39,400
TRYING TO FOCUS ON THAT, WE'VE

3997
02:36:39,400 --> 02:36:41,680
TRIED TO BUILD INTERNAL CAPACITY

3998
02:36:41,680 --> 02:36:43,000
THROUGH TRAINING FOR PROGRAM

3999
02:36:43,000 --> 02:36:44,760
DIRECTORS AS WELL AS AGAIN

4000
02:36:44,760 --> 02:36:48,360
EXPAND TRAINING MODULES FOR

4001
02:36:48,360 --> 02:36:49,560
EXTRAMURAL RESEARCH COMMUNITY

4002
02:36:49,560 --> 02:36:50,560
AGAIN CONTRIBUTING TO AND

4003
02:36:50,560 --> 02:36:52,000
BUILDING ON EVIDENCE AROUND

4004
02:36:52,000 --> 02:36:52,360
RECRUITMENT. 

4005
02:36:52,360 --> 02:36:54,840
I WILL STOP THERE.

4006
02:36:54,840 --> 02:36:55,080
THANK YOU.

4007
02:36:55,080 --> 02:36:57,840
>> TERRIFIC.

4008
02:36:57,840 --> 02:36:58,560
THANK YOU.

4009
02:36:58,560 --> 02:37:00,880
COMMENTS BEFORE WE MOVE ON TO

4010
02:37:00,880 --> 02:37:08,760
TISHA, ANYONE WANT TO WEIGH IN?

4011
02:37:08,760 --> 02:37:09,360
TISHA, THANK YOU.

4012
02:37:09,360 --> 02:37:09,840
>> GREAT.

4013
02:37:09,840 --> 02:37:10,600
THANK YOU ALL FOR THE

4014
02:37:10,600 --> 02:37:12,160
OPPORTUNITY TO BE HERE.

4015
02:37:12,160 --> 02:37:16,280
I'VE NOT BEEN INVOLVED IN THE

4016
02:37:16,280 --> 02:37:19,160
COLLABORATORY BUT I'VE BEEN A

4017
02:37:19,160 --> 02:37:23,960
LONG ADMIRER, GRATEFUL TO TO THE

4018
02:37:23,960 --> 02:37:27,560
VIEWPOINT -- TO LISTEN TO

4019
02:37:27,560 --> 02:37:27,880
REFLECTIONS.

4020
02:37:27,880 --> 02:37:32,040
MY PERSPECTIVE, I WORK AT THE

4021
02:37:32,040 --> 02:37:35,920
NATIONAL INSTITUTE 

4022
02:37:35,920 --> 02:37:39,400
NATIONAL INSTITUTE ON DRUG

4023
02:37:39,400 --> 02:37:40,960
ABUSE, BRANCH CHIEF FOR FIVE

4024
02:37:40,960 --> 02:37:43,240
YEARS, I HAD THE CHANCE TO LEARN

4025
02:37:43,240 --> 02:37:46,400
FROM A LOT OF INVESTIGATORS, AND

4026
02:37:46,400 --> 02:37:49,440
OUR BRANCH, THE WORK WE DO, IS

4027
02:37:49,440 --> 02:37:50,040
AS BEING HEALTH SERVICES

4028
02:37:50,040 --> 02:37:52,560
RESEARCH WE HAVE A LOT OF

4029
02:37:52,560 --> 02:37:55,200
EFFECTIVENESS TRIALS, A LOT OF

4030
02:37:55,200 --> 02:37:56,800
IMPLEMENTATION SCIENCE TRIALS, A

4031
02:37:56,800 --> 02:37:58,840
LOT OF PRAGMATIC TRIALS, AND THE

4032
02:37:58,840 --> 02:38:02,520
WORK OF OUR BRANCH IS PUSHING ON

4033
02:38:02,520 --> 02:38:04,560
THAT "SO WHAT."

4034
02:38:04,560 --> 02:38:08,160
WE'RE AT THE END OF THE

4035
02:38:08,160 --> 02:38:09,800
TRANSLATIONAL CONTINUUM, IF ANY

4036
02:38:09,800 --> 02:38:11,240
RESEARCH THAT SHOULD MAKE IMPACT

4037
02:38:11,240 --> 02:38:13,040
AND MOVING THE NEEDLE ON

4038
02:38:13,040 --> 02:38:14,000
ADDICTION SERVICES DELIVERY IN

4039
02:38:14,000 --> 02:38:15,280
THE REAL WORLD SHOULD BE THE

4040
02:38:15,280 --> 02:38:18,960
WORK OF MY BRANCH SO I WANT TO

4041
02:38:18,960 --> 02:38:21,520
SHIFT GEARS AND TALK ABOUT HOW

4042
02:38:21,520 --> 02:38:23,800
WHEN THINGS ARE GOING WRONG WHAT

4043
02:38:23,800 --> 02:38:25,040
INTERACTION WITH PROGRAM STAFF

4044
02:38:25,040 --> 02:38:27,560
LOOKS LIKE AND HOW REVIEWING OUR

4045
02:38:27,560 --> 02:38:30,480
JOBS OR AT LEAST I VIEW MY JOB

4046
02:38:30,480 --> 02:38:33,160
AND TEAM VIEWS MY JOB, I'M GOING

4047
02:38:33,160 --> 02:38:34,680
TO BROADEN THE DISCUSSION.

4048
02:38:34,680 --> 02:38:37,640
YOU ALL HAD A COUPLE UNIQUE

4049
02:38:37,640 --> 02:38:38,680
FEATURES, ONE, A LARGE

4050
02:38:38,680 --> 02:38:40,000
INITIATIVE WITH A LOT OF

4051
02:38:40,000 --> 02:38:41,000
INFRASTRUCTURE SUPPORTS.

4052
02:38:41,000 --> 02:38:42,800
YOU HAD A U MECHANISM WHICH

4053
02:38:42,800 --> 02:38:44,280
ALWAYS GIVES A LOT MORE

4054
02:38:44,280 --> 02:38:47,000
FLEXIBILITY THAN A TYPICAL R

4055
02:38:47,000 --> 02:38:48,000
MECHANISM AWARD.

4056
02:38:48,000 --> 02:38:49,200
YOU HAVE A PHASED STRUCTURE

4057
02:38:49,200 --> 02:38:52,040
WHICH CAN OFFER A NICE

4058
02:38:52,040 --> 02:38:53,680
OPPORTUNITY TO DO SOME OF THE

4059
02:38:53,680 --> 02:38:56,000
PILOT WORK AND THEN TRANSITION

4060
02:38:56,000 --> 02:38:59,160
IMMEDIATELY INTO THE LARGER

4061
02:38:59,160 --> 02:38:59,680
SCALE TRIALS.

4062
02:38:59,680 --> 02:39:03,000
THINGS I'M GOING TO SHARE ARE

4063
02:39:03,000 --> 02:39:04,840
APPLICABLE, WITH THOSE UNIQUE

4064
02:39:04,840 --> 02:39:08,800
CHARACTERISTICS, YOU CAN OFTEN

4065
02:39:08,800 --> 02:39:10,960
WRESTLE MORE DIRECTLY AND

4066
02:39:10,960 --> 02:39:12,480
ACTIVITY WITH R MECHANISM, NOT

4067
02:39:12,480 --> 02:39:14,120
ALWAYS HAVING DIALOGUE WHERE YOU

4068
02:39:14,120 --> 02:39:14,920
DON'T HAVE STRUCTURES BUILT IN

4069
02:39:14,920 --> 02:39:16,640
SO I'LL TALK ABOUT HOW THAT

4070
02:39:16,640 --> 02:39:18,520
CONVERSATION WITH THE P.O. MIGHT

4071
02:39:18,520 --> 02:39:20,160
GO AND HOW THE DISCUSSIONS ARE

4072
02:39:20,160 --> 02:39:22,120
SHAPING THE WAY THAT WE INFORM

4073
02:39:22,120 --> 02:39:24,080
WHAT WE'RE DOING AS WE'RE

4074
02:39:24,080 --> 02:39:25,960
THINKING ABOUT DESIGNING

4075
02:39:25,960 --> 02:39:27,920
PROGRAMS OR PUTTING OUT RFAs,

4076
02:39:27,920 --> 02:39:29,680
OFFER YOUR FEEDBACK ABOUT HOW WE

4077
02:39:29,680 --> 02:39:32,840
CAN AGAIN HELP MOVE THE NEEDLE

4078
02:39:32,840 --> 02:39:35,360
AND ADVANCE THAT "SO WHAT"

4079
02:39:35,360 --> 02:39:36,880
QUESTION SO WE'RE ADVANCING THE

4080
02:39:36,880 --> 02:39:39,960
IMPACT OF OUR WORK.

4081
02:39:39,960 --> 02:39:44,680
SO, HOW I VIEW MY JOB, IN MY

4082
02:39:44,680 --> 02:39:46,600
ROLE TO HELP BE A GOOD STEWARD

4083
02:39:46,600 --> 02:39:50,040
OF TAXPAYER DOLLARS, TO MAKE

4084
02:39:50,040 --> 02:39:51,120
SURE WE'RE INVESTING IN RESEARCH

4085
02:39:51,120 --> 02:39:55,520
IN A WAY THAT ADVANCES PUBLIC

4086
02:39:55,520 --> 02:39:56,160
HEALTH IMPACT.

4087
02:39:56,160 --> 02:39:57,560
MY BRANCH IN PARTICULAR, I VIEW

4088
02:39:57,560 --> 02:40:03,680
US AS BEING AT  AT THE END OF TE

4089
02:40:03,680 --> 02:40:04,040
CONTINUUM.

4090
02:40:04,040 --> 02:40:06,120
THERE'S A LOT OF RULES AT NIH,

4091
02:40:06,120 --> 02:40:07,680
LOTS OF WAYS TO TERM THAT.

4092
02:40:07,680 --> 02:40:10,400
WE NEED TO MAKE SURE WE'RE

4093
02:40:10,400 --> 02:40:11,480
COGNIZANT OF POLICY BUT ALSO

4094
02:40:11,480 --> 02:40:15,800
DOING THAT IN THE CONTEXT OF

4095
02:40:15,800 --> 02:40:17,320
UNDERSTANDING HOW WE MAXIMIZE

4096
02:40:17,320 --> 02:40:20,120
IMPACT OF TAXPAYER DOLLARS.

4097
02:40:20,120 --> 02:40:21,600
I'VE ENCOUNTERED A LOT OF

4098
02:40:21,600 --> 02:40:23,760
SITUATIONS WHERE STUDIES DIDN'T

4099
02:40:23,760 --> 02:40:24,880
GO AS PLANNED.

4100
02:40:24,880 --> 02:40:27,720
OFTEN THAT IS DESPITE THE BEST

4101
02:40:27,720 --> 02:40:30,640
EFFORTS AND HEROIC EFFORTS OF

4102
02:40:30,640 --> 02:40:32,160
THE INVESTIGATORS TO NAVIGATE

4103
02:40:32,160 --> 02:40:33,600
TOUGH SITUATIONS.

4104
02:40:33,600 --> 02:40:36,920
WHEN I ENCOUNTER THESE

4105
02:40:36,920 --> 02:40:39,200
SITUATIONS I'M ASKING FOUR KEY

4106
02:40:39,200 --> 02:40:39,960
QUESTIONS.

4107
02:40:39,960 --> 02:40:41,920
THE FIRST QUESTION IS WHAT IS

4108
02:40:41,920 --> 02:40:42,920
GOOD SCIENCE HERE?

4109
02:40:42,920 --> 02:40:44,480
WHAT LOOKS LIKE GOOD SCIENCE?

4110
02:40:44,480 --> 02:40:47,080
I COME BACK TO THE POINT IN A

4111
02:40:47,080 --> 02:40:47,320
MINUTE.

4112
02:40:47,320 --> 02:40:49,600
THE SECOND QUESTION I ASK MYSELF

4113
02:40:49,600 --> 02:40:51,320
IS HOW DO WE MAXIMIZE THE VALUE

4114
02:40:51,320 --> 02:40:56,600
OF THE  INVESTMENT WE'VE MADE?

4115
02:40:56,600 --> 02:40:58,680
WHAT WERE THE ORIGINAL GOALS AND

4116
02:40:58,680 --> 02:41:02,160
AIMS OF THE STUDY AND WHAT THE

4117
02:41:02,160 --> 02:41:03,280
INVESTIGATOR PROPOSING, HOW DOES

4118
02:41:03,280 --> 02:41:04,760
THE PROPOSAL FIT WITH THAT AND

4119
02:41:04,760 --> 02:41:08,640
WE TALK AT NIH ABOUT IS THAT IN

4120
02:41:08,640 --> 02:41:08,840
SCOPE.

4121
02:41:08,840 --> 02:41:11,000
AND DEPENDING ON DIFFERENT

4122
02:41:11,000 --> 02:41:12,800
INSTITUTES AND P.O.s MAY HAVE

4123
02:41:12,800 --> 02:41:15,200
DIFFERENT VIEWS OF WHAT IS IN

4124
02:41:15,200 --> 02:41:15,560
SCOPE.

4125
02:41:15,560 --> 02:41:16,920
BUT MY THINKING ABOUT THAT TENDS

4126
02:41:16,920 --> 02:41:18,840
TO BE INFORMED AGAIN BY WHAT WAS

4127
02:41:18,840 --> 02:41:20,000
THE BIG PICTURE, WHAT WERE WE

4128
02:41:20,000 --> 02:41:21,760
TRYING TO DO WITH THIS STUDY,

4129
02:41:21,760 --> 02:41:24,040
WHAT DID WE HOPE TO LEARN?

4130
02:41:24,040 --> 02:41:27,120
AND THEN THE MOST -- THE SORT

4131
02:41:27,120 --> 02:41:29,320
OF -- THAT TAKES YOU TO THE

4132
02:41:29,320 --> 02:41:30,080
QUESTION DOES CONTINUED

4133
02:41:30,080 --> 02:41:31,320
INVESTMENT IN THE INFRASTRUCTURE

4134
02:41:31,320 --> 02:41:34,200
THAT'S BEEN DEVELOPED BY THIS

4135
02:41:34,200 --> 02:41:35,880
STUDY REPRESENT A GOOD

4136
02:41:35,880 --> 02:41:37,600
STEWARDSHIP OF TAXPAYER DOLLARS?

4137
02:41:37,600 --> 02:41:40,000
IS THERE A GOOD -- IS THERE A

4138
02:41:40,000 --> 02:41:41,120
SCIENTIFIC OPPORTUNITY WITHIN

4139
02:41:41,120 --> 02:41:44,280
THAT STUDY THAT WE CAN LEARN

4140
02:41:44,280 --> 02:41:45,920
SOMETHING AND MOVE THE NEEDLE OR

4141
02:41:45,920 --> 02:41:47,800
IS IT TIME TO THINK ABOUT AN

4142
02:41:47,800 --> 02:41:48,600
ORDERLY CLOSEOUT?

4143
02:41:48,600 --> 02:41:53,080
I KNOW THAT'S ALWAYS A REALLY

4144
02:41:53,080 --> 02:41:54,160
TOUGH CONVERSATION, SOMETHING

4145
02:41:54,160 --> 02:41:56,120
THAT BRINGS INVESTIGATORS

4146
02:41:56,120 --> 02:41:56,480
ANXIETY.

4147
02:41:56,480 --> 02:41:57,440
FORTUNATELY IT'S A RARE

4148
02:41:57,440 --> 02:41:59,080
SITUATION WHERE A NUMBER OF

4149
02:41:59,080 --> 02:42:00,520
THINGS HAPPEN THAT THE STUDY

4150
02:42:00,520 --> 02:42:01,720
BECOMES INFEASIBLE.

4151
02:42:01,720 --> 02:42:02,800
MY EXPERIENCE, THERE'S ALMOST

4152
02:42:02,800 --> 02:42:05,520
ALWAYS SOMETHING THAT CAN BE

4153
02:42:05,520 --> 02:42:07,320
SALVAGED OR THOUGHT ABOUT IN A

4154
02:42:07,320 --> 02:42:09,280
DIFFERENT WAY AND STILL BRING IN

4155
02:42:09,280 --> 02:42:13,880
SCIENTIFIC VALUE FROM THE STUDY.

4156
02:42:13,880 --> 02:42:16,760
I THINK I CAN SHARE A COUPLE

4157
02:42:16,760 --> 02:42:18,480
EXAMPLES SO YOU CAN SEE WHAT

4158
02:42:18,480 --> 02:42:19,680
THIS MIGHT LOOK LIKE.

4159
02:42:19,680 --> 02:42:23,640
ONE EARLY IN MY CAREER AT NIH I

4160
02:42:23,640 --> 02:42:32,840
ENCOUNTERED A  A COMPLEX STUDY D

4161
02:42:32,840 --> 02:42:35,440
OF FOUR YEARS RECRUITED 5% OF

4162
02:42:35,440 --> 02:42:37,560
SAMPLE, IT WAS A VERY EXTENSIVE

4163
02:42:37,560 --> 02:42:41,920
STUDY, AND THAT'S ONE OF THE FEW

4164
02:42:41,920 --> 02:42:43,200
CASES WHERE A WHOLE LOT OF

4165
02:42:43,200 --> 02:42:44,960
THINGS HAVE GONE WRONG AND THERE

4166
02:42:44,960 --> 02:42:45,960
WASN'T MUCH THAT COULD GET THEM

4167
02:42:45,960 --> 02:42:47,920
BACK TO THE ORIGINAL GOAL BUT WE

4168
02:42:47,920 --> 02:42:50,440
FOUND A SET OF THINGS THAT STILL

4169
02:42:50,440 --> 02:42:51,840
MADE SENSE WITHIN THE OVERALL

4170
02:42:51,840 --> 02:42:53,400
GOALS OF THE ORIGINAL STUDY AND

4171
02:42:53,400 --> 02:42:55,640
CAME UP WITH A PLAN WHERE THE

4172
02:42:55,640 --> 02:42:58,200
INVESTIGATORS THEN DID A NUMBER

4173
02:42:58,200 --> 02:43:00,840
OF OTHER ACTIVITIES STILL IN

4174
02:43:00,840 --> 02:43:03,040
SCOPE OF THE ORIGINAL STUDY BUT

4175
02:43:03,040 --> 02:43:04,880
SORT OF CALLED IT QUITS WHEN

4176
02:43:04,880 --> 02:43:08,720
THEY HIT A DEAD END ON A

4177
02:43:08,720 --> 02:43:09,880
RECRUITMENT CHALLENGE.

4178
02:43:09,880 --> 02:43:12,320
I HAD ANOTHER STUDY THAT

4179
02:43:12,320 --> 02:43:13,840
ENCOUNTERED -- THIS IS ONE THING

4180
02:43:13,840 --> 02:43:16,040
I WANT TO OFFER BECAUSE

4181
02:43:16,040 --> 02:43:18,440
SOMETIMES BEING FLEXIBLE IS

4182
02:43:18,440 --> 02:43:18,760
IMPORTANT.

4183
02:43:18,760 --> 02:43:23,480
THERE'S ONE STUDY I  ENCOUNTERED

4184
02:43:23,480 --> 02:43:26,200
EARLY IN MY CAREER,

4185
02:43:26,200 --> 02:43:26,640
UNDERPOWERED.

4186
02:43:26,640 --> 02:43:27,440
WE HAD CONVERSATIONS WHETHER

4187
02:43:27,440 --> 02:43:30,840
THERE WAS GOING TO BE VALUE IN

4188
02:43:30,840 --> 02:43:33,280
CONTINUING THE STUDY GIVEN THE

4189
02:43:33,280 --> 02:43:33,600
CHALLENGES.

4190
02:43:33,600 --> 02:43:35,960
THAT UNDERPOWERED STUDY ENDED UP

4191
02:43:35,960 --> 02:43:37,800
GETTING PUBLISHED IN JAMA, AND

4192
02:43:37,800 --> 02:43:39,760
ENDED UP BEING QUITE

4193
02:43:39,760 --> 02:43:40,080
INFLUENTIAL.

4194
02:43:40,080 --> 02:43:41,400
IT PROVIDED SORT OF EVEN THOUGH

4195
02:43:41,400 --> 02:43:44,680
IT WAS NOT FULLY POWERED STILL

4196
02:43:44,680 --> 02:43:46,760
PROVIDED SOME REALLY PROVOCATIVE

4197
02:43:46,760 --> 02:43:49,600
DATA POINTS THAT SPURRED A LOT

4198
02:43:49,600 --> 02:43:50,680
OF ADDITIONAL RESEARCH AND

4199
02:43:50,680 --> 02:43:53,000
REALLY MOVED THE VIEWS OF THE

4200
02:43:53,000 --> 02:43:55,000
LEADERSHIP AT NIDA AS WELL AS

4201
02:43:55,000 --> 02:43:57,960
LEADERS IN THE FIELD AND ENDED

4202
02:43:57,960 --> 02:43:59,200
UP BEING EXTREMELY INFLUENTIAL

4203
02:43:59,200 --> 02:44:00,560
STUDY, ONE STUDY I KEEP IN MIND

4204
02:44:00,560 --> 02:44:04,560
AS I THINK ABOUT THESE DIFFICULT

4205
02:44:04,560 --> 02:44:05,920
CONVERSATIONS BECAUSE THERE IS

4206
02:44:05,920 --> 02:44:08,000
THE BROADER PICTURE, NOT JUST

4207
02:44:08,000 --> 02:44:08,880
ARE WE HITTING RECRUITMENT GOALS

4208
02:44:08,880 --> 02:44:14,920
BUT WHERE IS THE BIGGER

4209
02:44:14,920 --> 02:44:16,320
SCIENTIFIC QUESTION GOING.

4210
02:44:16,320 --> 02:44:18,880
I'LL SHARE ANOTHER SORT OF

4211
02:44:18,880 --> 02:44:21,920
OBSERVATION THERE'S A NEED, THIS

4212
02:44:21,920 --> 02:44:23,000
PIVOT, WHERE A PIVOT HAS BEEN

4213
02:44:23,000 --> 02:44:23,280
IMPORTANT.

4214
02:44:23,280 --> 02:44:26,800
A LOT OF WORK I DO AND A LOT OF

4215
02:44:26,800 --> 02:44:28,240
WORK MY BRANCH FUNDS IS IN THE

4216
02:44:28,240 --> 02:44:30,000
JUSTICE SECTOR AND WE DO A LOT

4217
02:44:30,000 --> 02:44:31,280
OF WORK HOW PEOPLE ARE

4218
02:44:31,280 --> 02:44:33,520
TRANSITIONING BETWEEN HEALTH

4219
02:44:33,520 --> 02:44:34,920
CARE SYSTEMS AND JUSTICE

4220
02:44:34,920 --> 02:44:35,160
SYSTEMS.

4221
02:44:35,160 --> 02:44:38,040
A LOT OF TRIALS WE FUND RECRUIT

4222
02:44:38,040 --> 02:44:40,440
OUT OF JAILS AS PEOPLE ARE

4223
02:44:40,440 --> 02:44:42,400
RETURNING TO THE COMMUNITY, IF

4224
02:44:42,400 --> 02:44:43,960
YOU FOLLOW THE NEWS THERE HAVE

4225
02:44:43,960 --> 02:44:47,040
BEEN A LOT OF MAJOR UPHEAVALS IN

4226
02:44:47,040 --> 02:44:48,920
THE JUSTICE SYSTEM OVER THE LAST

4227
02:44:48,920 --> 02:44:52,440
FEW YEARS, CASH BAIL REFORM,

4228
02:44:52,440 --> 02:44:54,240
MASS RELEASES DURING COVID, TONS

4229
02:44:54,240 --> 02:44:54,960
OF POLICY ISSUES.

4230
02:44:54,960 --> 02:44:58,160
AND WE'VE HAD A NUMBER OF

4231
02:44:58,160 --> 02:44:59,960
STUDIES THAT JUST AS THESE

4232
02:44:59,960 --> 02:45:02,120
HAPPENED IN REAL TIME WHILE

4233
02:45:02,120 --> 02:45:03,200
COLLECTING SUDDENLY RECRUITMENT

4234
02:45:03,200 --> 02:45:04,840
STRATEGY OF RECRUITING FROM

4235
02:45:04,840 --> 02:45:06,480
JAILS BECOMES IMPOSSIBLE BECAUSE

4236
02:45:06,480 --> 02:45:09,120
THE FOLKS AREN'T WHERE THEY

4237
02:45:09,120 --> 02:45:09,360
EXPECT.

4238
02:45:09,360 --> 02:45:10,560
THAT ACTUALLY REPRESENTS A GOOD

4239
02:45:10,560 --> 02:45:12,200
MOVEMENT IN TERMS OF WHERE WE'D

4240
02:45:12,200 --> 02:45:13,840
LIKE THE FIELD TO GO BUT A

4241
02:45:13,840 --> 02:45:15,480
CHALLENGE FOR THE STUDY.

4242
02:45:15,480 --> 02:45:18,880
WE'VE BEEN ABLE TO FIND WAYS TO

4243
02:45:18,880 --> 02:45:20,080
PIVOT RECRUITMENT STRATEGY TO

4244
02:45:20,080 --> 02:45:21,720
CAPTURE THE GROUP OF FOLKS WHERE

4245
02:45:21,720 --> 02:45:24,480
WE CAN FIND THEM AND ADDRESS THE

4246
02:45:24,480 --> 02:45:29,040
BROADER QUESTIONS OF THE STUDY

4247
02:45:29,040 --> 02:45:29,280
DESIGN.

4248
02:45:29,280 --> 02:45:32,360
I WANT TO TOUCH ON WHAT IS GOOD

4249
02:45:32,360 --> 02:45:32,560
SCIENCE.

4250
02:45:32,560 --> 02:45:35,600
ONE THING IN SOME OF MY

4251
02:45:35,600 --> 02:45:36,280
EXPERIENCES WORKING ON

4252
02:45:36,280 --> 02:45:37,600
IMPLEMENTATION TRIALS I WOULD

4253
02:45:37,600 --> 02:45:39,120
ENCOURAGE THINKING FROM A DESIGN

4254
02:45:39,120 --> 02:45:41,080
PERSPECTIVE IS HOW DO WE THINK

4255
02:45:41,080 --> 02:45:44,480
ABOUT -- IT ALIGNS WITH DAVID'S

4256
02:45:44,480 --> 02:45:46,880
COMMENTS ABOUT THE PRE-MORTEM

4257
02:45:46,880 --> 02:45:48,000
APPROACH, STRUCTURING STUDIES SO

4258
02:45:48,000 --> 02:45:49,720
EVEN IF THINGS DON'T GO AS

4259
02:45:49,720 --> 02:45:51,120
PLANNED THAT'S INFORMATIVE,

4260
02:45:51,120 --> 02:45:53,120
THAT'S AN OUTCOME.

4261
02:45:53,120 --> 02:45:54,840
IF LEADERSHIP WON'T ADOPT AND

4262
02:45:54,840 --> 02:45:57,400
IMPLEMENTATION PLAN DEVELOPED BY

4263
02:45:57,400 --> 02:46:00,120
A LOCAL TEAM, THAT COULD BE AN

4264
02:46:00,120 --> 02:46:04,360
OUTCOME THAT IS OF INTEREST IN

4265
02:46:04,360 --> 02:46:05,600
OUR STUDY.

4266
02:46:05,600 --> 02:46:07,120
ALSO, YOU KNOW, WHEN THINGS SEEM

4267
02:46:07,120 --> 02:46:09,200
LIKE A GOOD IDEA AT THE TIME BUT

4268
02:46:09,200 --> 02:46:13,120
THEN IN THE END DON'T QUITE WORK

4269
02:46:13,120 --> 02:46:15,560
AS PLANNED, THERE'S OFTEN

4270
02:46:15,560 --> 02:46:17,280
RESISTANT -- THERE'S

4271
02:46:17,280 --> 02:46:19,480
HISTORICALLY BEEN DIFFICULTY

4272
02:46:19,480 --> 02:46:20,680
PUBLISHING NULL FINDINGS IN

4273
02:46:20,680 --> 02:46:22,240
LITERATURE BUT SOMETIMES WHEN WE

4274
02:46:22,240 --> 02:46:23,640
FIND THESE THINGS DON'T GO AS

4275
02:46:23,640 --> 02:46:25,280
PLANNED WE'VE GOT TO PUT THAT

4276
02:46:25,280 --> 02:46:26,720
OUT IN THE LITERATURE.

4277
02:46:26,720 --> 02:46:30,760
SO I KNOW THE STUDY RECENTLY I

4278
02:46:30,760 --> 02:46:33,120
SAW WHERE THEIR GOAL WAS TO GET

4279
02:46:33,120 --> 02:46:34,960
PEOPLE REFERRED INTO TREATMENT.

4280
02:46:34,960 --> 02:46:36,800
THINKING WITH THAT REFERRAL TO

4281
02:46:36,800 --> 02:46:38,200
TREATMENT IN MY WORLD WE'RE

4282
02:46:38,200 --> 02:46:39,960
OFTEN FOCUSED ON TRYING TO GET

4283
02:46:39,960 --> 02:46:41,080
PEOPLE TO USE MEDICATIONS FOR

4284
02:46:41,080 --> 02:46:45,200
OPIOID USE DIS DISORDER, GETTING

4285
02:46:45,200 --> 02:46:46,840
REFERRALS TO TREATMENT WOULD

4286
02:46:46,840 --> 02:46:48,720
LEAD TO THE UPTAKE OF

4287
02:46:48,720 --> 02:46:49,600
MEDICATIONS FOR OPIOID USE

4288
02:46:49,600 --> 02:46:51,120
DISORDER BUT IT DIDN'T QUITE

4289
02:46:51,120 --> 02:46:51,320
WORK.

4290
02:46:51,320 --> 02:46:53,320
THEY GOT REFERRALS BUT NOT

4291
02:46:53,320 --> 02:46:55,080
UPTAKE OF THE MEDICATIONS.

4292
02:46:55,080 --> 02:46:56,920
SO AGAIN FOR THAT STUDY WE'RE

4293
02:46:56,920 --> 02:46:58,040
LOOKING AT FUNDING ADDITIONAL

4294
02:46:58,040 --> 02:47:03,280
WORK TO SEE WHAT BROKE DOWN IN

4295
02:47:03,280 --> 02:47:06,200
THE ASSUMPTION OF HOF THIS IS --

4296
02:47:06,200 --> 02:47:08,960
HOW THIS IS GOING TO WORK.

4297
02:47:08,960 --> 02:47:10,040
STAKEHOLDER ENGAGEMENT IS

4298
02:47:10,040 --> 02:47:11,240
CRITICAL TOO, YOU'RE BETTER

4299
02:47:11,240 --> 02:47:12,960
POSITIONED TO TAKE THAT APART

4300
02:47:12,960 --> 02:47:14,640
AND THINK ABOUT WHY DID THINGS

4301
02:47:14,640 --> 02:47:16,400
NOT GO AS PLANNED.

4302
02:47:16,400 --> 02:47:17,400
INCLUDING THINKING ABOUT HOW

4303
02:47:17,400 --> 02:47:25,440
THIS IS ALIGNING WITH IN INCENTS

4304
02:47:25,440 --> 02:47:26,440
FROM STAKEHOLDERS.

4305
02:47:26,440 --> 02:47:28,640
HOW THESE HAVE INFORMED HOW WE

4306
02:47:28,640 --> 02:47:30,480
STRUCTURE FUNDING ANNOUNCEMENTS

4307
02:47:30,480 --> 02:47:32,880
AND INITIATIVES, AND IF YOU LOOK

4308
02:47:32,880 --> 02:47:34,880
AT THE RFAs MY TEAM HAS BEEN

4309
02:47:34,880 --> 02:47:37,920
PUTTING OUT OVER THE LAST COUPLE

4310
02:47:37,920 --> 02:47:40,000
YEARS, WE TALKED ABOUT A LOT OF

4311
02:47:40,000 --> 02:47:42,560
THESE ISSUES AND OBSERVATIONS IN

4312
02:47:42,560 --> 02:47:43,560
A RETREAT.

4313
02:47:43,560 --> 02:47:44,840
ONE OF THE PANELISTS YESTERDAY

4314
02:47:44,840 --> 02:47:46,720
TALKED ABOUT THE FOUR Ss.

4315
02:47:46,720 --> 02:47:57,160
FOR US WE CALL THEM SPECS,

4316
02:48:07,600 --> 02:48:08,520
SCALABILITY, SUSTAINABILITY,

4317
02:48:08,520 --> 02:48:09,360
STAKEHOLDER ENGAGEMENT.

4318
02:48:09,360 --> 02:48:10,800
FOR US IN SERVICES RESEARCH AT

4319
02:48:10,800 --> 02:48:12,520
NIDA IF WE'RE GOING TO MOVE THE

4320
02:48:12,520 --> 02:48:14,440
NEEDLE WE NEED TO BE THINKING

4321
02:48:14,440 --> 02:48:16,160
ABOUT THOSE ISSUES IN ALL OF OUR

4322
02:48:16,160 --> 02:48:17,480
RESEARCH.

4323
02:48:17,480 --> 02:48:19,320
WE'RE HOPING WE'RE GOING TO SEE

4324
02:48:19,320 --> 02:48:21,280
OVER THE NEXT FEW YEARS WE'RE

4325
02:48:21,280 --> 02:48:22,600
MAKING PROGRESS, THAT WE AREN'T

4326
02:48:22,600 --> 02:48:24,120
WHERE WE ARE TODAY, THAT WE'RE

4327
02:48:24,120 --> 02:48:29,040
IN FIVE YEARS FROM NOW ABLE TO

4328
02:48:29,040 --> 02:48:32,360
MOVE THE FIELD EVEN FURTHER.

4329
02:48:32,360 --> 02:48:34,000
THE LAST THING I WANT TO SHARE

4330
02:48:34,000 --> 02:48:36,160
TOO IS AGAIN AS WE THINK ABOUT

4331
02:48:36,160 --> 02:48:38,800
THIS WORK, I'VE HEARD THESE

4332
02:48:38,800 --> 02:48:41,120
TENSIONS BETWEEN WHAT IS

4333
02:48:41,120 --> 02:48:44,360
GENERALIZABLE VERSUS WHAT'S

4334
02:48:44,360 --> 02:48:46,920
SPECIFIC TO A CONTEXT, WHERE IS

4335
02:48:46,920 --> 02:48:50,520
SCIENTIFIC KNOWLEDGE, WE DON'T

4336
02:48:50,520 --> 02:48:52,480
HAVE RESOURCES TO TEST EVERY

4337
02:48:52,480 --> 02:48:53,880
INTERVENTION AN SETTING, WE'RE

4338
02:48:53,880 --> 02:48:57,040
STRUGGLING ARE WE MOVING THE

4339
02:48:57,040 --> 02:48:57,800
SCIENTIFIC NEEDLE, MOVING

4340
02:48:57,800 --> 02:49:00,240
PRAGMATIC NEEDLE OF HOW WE'RE

4341
02:49:00,240 --> 02:49:02,120
ACHIEVING OUR DESIRED OUTCOME AS

4342
02:49:02,120 --> 02:49:03,800
AN INSTITUTE, WHICH IS IMPROVING

4343
02:49:03,800 --> 02:49:06,640
DELIVERY OF SERVICES TO WORK TO

4344
02:49:06,640 --> 02:49:08,280
POPULATIONS THAT NEED THEM, AND

4345
02:49:08,280 --> 02:49:10,880
HOW DO WE BALANCE MAKING SURE

4346
02:49:10,880 --> 02:49:12,600
WE'RE ADDRESSING EQUITY, BEING

4347
02:49:12,600 --> 02:49:15,600
MINDFUL OF CONTEXT, ALSO DON'T

4348
02:49:15,600 --> 02:49:18,760
FALL INTO THIS TRAP OF TESTING

4349
02:49:18,760 --> 02:49:21,160
EVERY INTERVENTION AND POSSIBLE

4350
02:49:21,160 --> 02:49:22,520
ITERATION, AND NOT MOVING THE

4351
02:49:22,520 --> 02:49:23,360
BALL DOWN THE FIELD.

4352
02:49:23,360 --> 02:49:31,120
THANK YOU FOR THE OPPORTUNITY TO

4353
02:49:31,120 --> 02:49:31,840
SHARE SOME THOUGHTS.

4354
02:49:31,840 --> 02:49:33,640
>> THAT WAS TERRIFIC.

4355
02:49:33,640 --> 02:49:35,760
THANKS, TISHA.

4356
02:49:35,760 --> 02:49:38,800
WE'RE IN THE OPENING COMMENT

4357
02:49:38,800 --> 02:49:40,760
SECTION OF THIS PANEL, HANDS UP

4358
02:49:40,760 --> 02:49:42,880
IF YOU'D LIKE TO COMMENT.

4359
02:49:42,880 --> 02:49:44,280
WHILE WE'RE WAITING FOR THE

4360
02:49:44,280 --> 02:49:48,960
HANDS TO GO UP, COULD I ASK THE

4361
02:49:48,960 --> 02:49:52,760
THREE OF YOU NIH FOLKS TO TALK A

4362
02:49:52,760 --> 02:49:56,400
LITTLE MORE ABOUT WHAT

4363
02:49:56,400 --> 02:50:02,320
CONSTITUTES IN SCOPE, AND I'M

4364
02:50:02,320 --> 02:50:04,200
SURE THERE'S NO CARVED-IN-STONE

4365
02:50:04,200 --> 02:50:06,600
GUIDANCE ON THAT.

4366
02:50:06,600 --> 02:50:10,760
BUT TAKE THE HYPOTHETICAL

4367
02:50:10,760 --> 02:50:15,880
EXAMPLE OF A STUDY THAT REACHES

4368
02:50:15,880 --> 02:50:24,440
ITS GOAL A COUPLE YEARS EARLY,

4369
02:50:24,440 --> 02:50:27,080
FIVE YEAR STUDY, THREE YEARS,

4370
02:50:27,080 --> 02:50:30,760
TWO MORE YEARS OF FUNDING, IS IT

4371
02:50:30,760 --> 02:50:32,520
IN SCOPE TO PROPOSE HIGH-QUALITY

4372
02:50:32,520 --> 02:50:35,680
EXTENSION OF THE WORK THAT THEY

4373
02:50:35,680 --> 02:50:40,720
HAVE DONE?

4374
02:50:40,720 --> 02:50:41,160
OR NO?

4375
02:50:41,160 --> 02:50:42,800
>> I LOVE THE
HYPOTHETICAL.

4376
02:50:42,800 --> 02:50:44,440
IT'S ONE WE LOVE TO SEE AS MANY

4377
02:50:44,440 --> 02:50:45,600
TIMES AS POSSIBLE.

4378
02:50:45,600 --> 02:50:47,920
I MEAN, I DO THINK, CERTAINLY

4379
02:50:47,920 --> 02:50:51,760
CURIOUS WHAT TISHA AND WYNNE

4380
02:50:51,760 --> 02:50:54,160
THINK AS WELL, WITHIN SCOPE HAS

4381
02:50:54,160 --> 02:50:55,600
GENERALLY BEEN A REASONABLY

4382
02:50:55,600 --> 02:50:57,400
BROAD CATEGORY, JUST WITH THE

4383
02:50:57,400 --> 02:50:59,520
IDEA THAT, YOU KNOW, THERE'S A

4384
02:50:59,520 --> 02:51:01,400
PREMISE AROUND A DIFFERENT

4385
02:51:01,400 --> 02:51:02,960
STUDY, STUDIES MAY HAVE, YOU

4386
02:51:02,960 --> 02:51:04,400
KNOW, A PARTICULAR SET OF

4387
02:51:04,400 --> 02:51:06,440
SPECIFIC AIMS BUT THERE MAY BE

4388
02:51:06,440 --> 02:51:07,520
OTHER RELEVANT QUESTIONS THAT

4389
02:51:07,520 --> 02:51:10,520
CAN BE ASKED AND ANSWERED WITHIN

4390
02:51:10,520 --> 02:51:12,560
THE CONFINES OF THE

4391
02:51:12,560 --> 02:51:13,440
INVESTIGATION.

4392
02:51:13,440 --> 02:51:16,720
SO, YEAH, I WOULD ASSUME THAT IN

4393
02:51:16,720 --> 02:51:19,120
CONVERSATION WITH PROGRAM STAFF,

4394
02:51:19,120 --> 02:51:21,240
WITH GRANTS MANAGEMENT, AND THE

4395
02:51:21,240 --> 02:51:22,640
INVESTIGATIVE TEAM IDENTIFYING

4396
02:51:22,640 --> 02:51:25,480
WHAT ARE SORT OF ADDITIONAL

4397
02:51:25,480 --> 02:51:26,880
OPPORTUNITIES WITHIN THE SAME

4398
02:51:26,880 --> 02:51:27,920
GENERAL RESEARCH AGENDA THAT

4399
02:51:27,920 --> 02:51:32,720
COULD BE TAKEN ON WITH APPROVAL,

4400
02:51:32,720 --> 02:51:35,000
WOULD MEET THAT VERY HAPPY

4401
02:51:35,000 --> 02:51:37,520
HYPOTHETICAL THAT YOU -- I DON'T

4402
02:51:37,520 --> 02:51:38,960
KNOW, TISHA AND WYNNE IF YOU

4403
02:51:38,960 --> 02:51:40,240
WANT TO ADD.

4404
02:51:40,240 --> 02:51:42,000
>> I WOULD BE OVER THE
MOON TO

4405
02:51:42,000 --> 02:51:43,920
SEE -- SO IN THOSE CASES I'D BE

4406
02:51:43,920 --> 02:51:45,960
OVER THE MOON TO SEE A STUDY

4407
02:51:45,960 --> 02:51:47,680
THAT COMPLETED IN THREE YEARS

4408
02:51:47,680 --> 02:51:52,400
WHEN THEY PROPOSED FIVE

4409
02:51:52,400 --> 02:51:55,680
ORIGINALLY, BUT IT MAY MAKE YOU

4410
02:51:55,680 --> 02:51:57,080
QUESTION THERE WAS WORK THAT

4411
02:51:57,080 --> 02:51:58,400
HAPPENED BEFORE THE STUDY

4412
02:51:58,400 --> 02:51:59,840
PROPOSAL BECAUSE IN GENERAL WHAT

4413
02:51:59,840 --> 02:52:01,920
WE SEE IS IT TAKES PEOPLE JUST A

4414
02:52:01,920 --> 02:52:05,160
YEAR TO GET STARTED UP.

4415
02:52:05,160 --> 02:52:08,560
BUT LET ME NOT MAKE ANY NEGATIVE

4416
02:52:08,560 --> 02:52:11,760
ATTRIBUTIONS AND ASSUME IT JUST

4417
02:52:11,760 --> 02:52:13,600
REFLECTS AMAZING SUCCESS AND A

4418
02:52:13,600 --> 02:52:14,280
PRODUCTIVE TEAM.

4419
02:52:14,280 --> 02:52:19,080
WE WANT TO CONTINUE TO SUPPORT

4420
02:52:19,080 --> 02:52:20,480
SUCCESS UPON SUCCESS, SO IN

4421
02:52:20,480 --> 02:52:22,040
TERMS OF IN SCOPE I THINK I

4422
02:52:22,040 --> 02:52:23,800
ALWAYS TRY TO THINK OF IT AS

4423
02:52:23,800 --> 02:52:27,280
LIKE COULD I HAVE SEEN IT AS A

4424
02:52:27,280 --> 02:52:29,680
FOURTH AIM, AN UNSPOKEN FOURTH

4425
02:52:29,680 --> 02:52:31,560
AIM, YOU HAVE TO GIVE THREE

4426
02:52:31,560 --> 02:52:32,880
AIMS, COULD WHAT'S BEING

4427
02:52:32,880 --> 02:52:33,880
PROPOSED -- DOES IT LOOK LIKE IT

4428
02:52:33,880 --> 02:52:37,040
WAS SORT OF AN AIM THAT WASN'T

4429
02:52:37,040 --> 02:52:38,680
QUITE ARTICULATED OR COULD HAVE

4430
02:52:38,680 --> 02:52:39,560
BEEN ARTICULATED IN THE CONTEXT

4431
02:52:39,560 --> 02:52:42,080
OF THE WHOLE GRANT?

4432
02:52:42,080 --> 02:52:43,960
THE MORE THAT YOU -- IN THOSE

4433
02:52:43,960 --> 02:52:45,560
LOTS OF WAYS TO VIEW IT, IT'S

4434
02:52:45,560 --> 02:52:48,400
OFTEN IN THE EYE OF THE

4435
02:52:48,400 --> 02:52:50,160
BEHOLDER, SOME INSTITUTES AND

4436
02:52:50,160 --> 02:52:53,120
P.O.s ARE MORE CONSERVATIVE

4437
02:52:53,120 --> 02:52:56,520
HOW THAT VIEW THAT QUESTION IN

4438
02:52:56,520 --> 02:52:58,360
SCOPE, MIGHT BE CONTEXTUAL OTHER

4439
02:52:58,360 --> 02:53:01,080
THINGS BEYOND THE GRANT WITHIN

4440
02:53:01,080 --> 02:53:02,640
THE INSTITUTE BUT IF I COULD

4441
02:53:02,640 --> 02:53:04,360
ENVISION IT HAVING BEEN PART OF

4442
02:53:04,360 --> 02:53:07,680
THE ORIGINAL PROPOSAL IN SOME

4443
02:53:07,680 --> 02:53:09,960
WAY, SHAPE OR FORM, I'M OFTEN

4444
02:53:09,960 --> 02:53:12,280
MORE COMFORTABLE THINKING ABOUT

4445
02:53:12,280 --> 02:53:15,800
IT AS IN SCOPE.

4446
02:53:15,800 --> 02:53:17,440
>> I'LL JUST ADD ON

4447
02:53:17,440 --> 02:53:18,640
HYPOTHETICAL LINES ECHOING WHAT

4448
02:53:18,640 --> 02:53:20,760
TISHA AND DAVID SAID AROUND

4449
02:53:20,760 --> 02:53:22,240
WORKING WITH PEER GRANTS

4450
02:53:22,240 --> 02:53:25,840
MANAGEMENT AND YOUR P.O. AROUND

4451
02:53:25,840 --> 02:53:29,160
POTENTIAL EXTENSION OF THAT, I

4452
02:53:29,160 --> 02:53:31,240
THINK AN ADDITIONAL YEAR OR TWO

4453
02:53:31,240 --> 02:53:32,640
ONCE YOU COMPLETED YOUR TRIAL,

4454
02:53:32,640 --> 02:53:35,360
THIS MIGHT BE SEEN AS WITHIN

4455
02:53:35,360 --> 02:53:36,800
SCOPE, TO STUDY SUSTAINABILITY,

4456
02:53:36,800 --> 02:53:39,520
AND THAT IS OFTEN QUITE

4457
02:53:39,520 --> 02:53:41,520
DIFFICULT BECAUSE, YOU KNOW,

4458
02:53:41,520 --> 02:53:43,600
ONCE YOU GOT A TRIAL GOING

4459
02:53:43,600 --> 02:53:47,320
THERE'S USUALLY A LAG TIME

4460
02:53:47,320 --> 02:53:48,840
BETWEEN WHEN THE TRIAL IS DONE

4461
02:53:48,840 --> 02:53:53,000
AND YOU MIGHT HAVE RO3 OR R21 TO

4462
02:53:53,000 --> 02:53:54,360
STUDY SUSTAINABILITY.

4463
02:53:54,360 --> 02:53:56,400
IF IT OCCURS WITHIN THE SAME

4464
02:53:56,400 --> 02:53:57,800
GRANT PERIOD WOULD BE A NICE

4465
02:53:57,800 --> 02:53:59,360
OPPORTUNITY TO LOOK AT WHAT

4466
02:53:59,360 --> 02:54:00,360
EXTENT THE INTERVENTION IS

4467
02:54:00,360 --> 02:54:02,080
SUSTAINED, TO WHAT EXTENT YOU

4468
02:54:02,080 --> 02:54:03,520
SEE THE SAME EFFECTS OVER TIME,

4469
02:54:03,520 --> 02:54:06,840
AS WELL A LITTLE WHAT WE'VE DONE

4470
02:54:06,840 --> 02:54:09,320
A WHILE AGO AT NCI IS

4471
02:54:09,320 --> 02:54:11,480
SUPPLEMENTS TO REALLY TRY AND

4472
02:54:11,480 --> 02:54:12,600
PACKAGE THE INTERVENTION, AND

4473
02:54:12,600 --> 02:54:16,000
MAYBE PILOT TEST IT OR GET SOME

4474
02:54:16,000 --> 02:54:17,520
QUALITATIVE AND QUANTITATIVE

4475
02:54:17,520 --> 02:54:20,400
DATA WITH OTHER SITES WHO MIGHT

4476
02:54:20,400 --> 02:54:23,200
BE INTERESTED IN USING THIS

4477
02:54:23,200 --> 02:54:25,960
INTERVENTION, AGAIN KIND OF AT

4478
02:54:25,960 --> 02:54:27,720
THE SCALE OF CONSIDERATION IN

4479
02:54:27,720 --> 02:54:28,480
ADDITION TO SUSTAINABILITY

4480
02:54:28,480 --> 02:54:31,320
THINKING ABOUT THAT.

4481
02:54:31,320 --> 02:54:33,200
AGAIN, IT'S TRIAL BY TRIAL BASIS

4482
02:54:33,200 --> 02:54:37,880
BUT I COULD SEE THOSE AS FALLING

4483
02:54:37,880 --> 02:54:39,640
WITHIN BROADLY SPEAKING WITHIN

4484
02:54:39,640 --> 02:54:42,360
SCOPE AND REALLY IMPORTANT

4485
02:54:42,360 --> 02:54:43,560
RESEARCH QUESTIONS AS WELL.

4486
02:54:43,560 --> 02:54:44,320
>> TERRIFIC.

4487
02:54:44,320 --> 02:54:46,480
DAVID, I SEE YOU'VE POSTED LINKS

4488
02:54:46,480 --> 02:54:47,160
IN THE CHAT.

4489
02:54:47,160 --> 02:54:49,480
DO YOU WANT TO MENTION WHAT THEY

4490
02:54:49,480 --> 02:54:49,640
ARE?

4491
02:54:49,640 --> 02:54:50,680
>>YEAH, SURE.

4492
02:54:50,680 --> 02:54:52,640
I DON'T KNOW, DOES EVERYONE HAVE

4493
02:54:52,640 --> 02:54:53,520
ACCESS TO THE CHAT?

4494
02:54:53,520 --> 02:54:56,160
THIS IS FROM A COMMENT THAT

4495
02:54:56,160 --> 02:54:59,760
ERRED HAD MADE WANTING TO HEAR

4496
02:54:59,760 --> 02:55:02,280
MORE ABOUT PRE-MORTEM APPROACHES

4497
02:55:02,280 --> 02:55:04,480
AND EXAMPLES.

4498
02:55:04,480 --> 02:55:07,520
YEAH, SO THE GENERAL IDEA IS

4499
02:55:07,520 --> 02:55:09,400
THAT YOU'RE LOOKING AFTER THE

4500
02:55:09,400 --> 02:55:15,200
FACT PRE-MORTEM TO SEE WHAT WENT

4501
02:55:15,200 --> 02:55:15,640
WRONG.

4502
02:55:15,640 --> 02:55:17,280
PRE-MORTEM IS GATHERING RELEVANT

4503
02:55:17,280 --> 02:55:18,800
FOLKS TO ANTICIPATE WHAT ARE ALL

4504
02:55:18,800 --> 02:55:20,680
THE THINGS THAT MIGHT GO WRONG.

4505
02:55:20,680 --> 02:55:24,280
THERE WAS A RECENT EXAMPLE OF A

4506
02:55:24,280 --> 02:55:25,400
GROUP OF IMPLEMENTATION

4507
02:55:25,400 --> 02:55:29,000
SCIENTISTS WHO GOT TOGETHER AND

4508
02:55:29,000 --> 02:55:30,120
BASICALLY THROUGH GATHERING A

4509
02:55:30,120 --> 02:55:31,640
FAIR AMOUNT OF INFORMATION WERE

4510
02:55:31,640 --> 02:55:32,680
PROJECTING WHAT ARE DIFFERENT

4511
02:55:32,680 --> 02:55:35,480
WAYS IN WHICH SOME OF OUR

4512
02:55:35,480 --> 02:55:36,840
EFFORTS DON'T HAVE THAT IMPACT

4513
02:55:36,840 --> 02:55:39,080
THAT WE'D LIKE THEM TO HAVE SO

4514
02:55:39,080 --> 02:55:44,320
THAT WAS A PRE-MORTEM APPROACH

4515
02:55:44,320 --> 02:55:45,760
AND THERE'S BEEN INDUSTRY,

4516
02:55:45,760 --> 02:55:46,960
THERE'S BUSINESS, INDUSTRIES

4517
02:55:46,960 --> 02:55:48,600
HAVE USED PRE-MORTEM ANALYSIS TO

4518
02:55:48,600 --> 02:55:50,560
TRY AND PRIOR TO LAUNCHING A

4519
02:55:50,560 --> 02:55:52,760
PRODUCT OR PRIOR TO INITIATING

4520
02:55:52,760 --> 02:55:54,840
SOME LARGE SCALE CHANGE OF

4521
02:55:54,840 --> 02:55:56,320
TRYING TO BRAINSTORM DIFFERENT

4522
02:55:56,320 --> 02:55:59,520
THINGS THAT MIGHT HAPPEN AND HOW

4523
02:55:59,520 --> 02:56:01,840
DO WE TRY, BY RECOGNIZING WHAT'S

4524
02:56:01,840 --> 02:56:03,720
GOING TO GO WRONG, THE

4525
02:56:03,720 --> 02:56:07,520
HYPOTHETICAL FOR THIS

4526
02:56:07,520 --> 02:56:09,960
PRE-MORTEM, WHAT DO WE DO TO

4527
02:56:09,960 --> 02:56:12,560
INSULATE OUR PROCESS OR EFFORTS

4528
02:56:12,560 --> 02:56:13,640
FROM THAT.

4529
02:56:13,640 --> 02:56:15,720
IF PEOPLE DON'T HAVE ACCESS TO

4530
02:56:15,720 --> 02:56:18,720
THE CHAT WE CAN MAKE SURE TO

4531
02:56:18,720 --> 02:56:19,480
PROVIDE THE LINKS.

4532
02:56:19,480 --> 02:56:21,360
>> I'M TOLD THAT NOT
EVERYONE

4533
02:56:21,360 --> 02:56:25,880
DOES HAVE IT SO WE'LL PUT THEM

4534
02:56:25,880 --> 02:56:27,680
IN THE SHOW NOTES.

4535
02:56:27,680 --> 02:56:28,000
>> PERFECT.

4536
02:56:28,000 --> 02:56:31,640
>> SO OTHERS CAN SEE
THEM.

4537
02:56:31,640 --> 02:56:34,160
ONE OF THE LINES OF OUR

4538
02:56:34,160 --> 02:56:36,920
CONVERSATION IS THERE'S NO

4539
02:56:36,920 --> 02:56:43,200
SUBSTITUTE FOR PLANNING FOR

4540
02:56:43,200 --> 02:56:45,800
CONTINGENCIES.

4541
02:56:45,800 --> 02:56:48,880
EVEN UNKNOWNS ARE WORTH TRYING

4542
02:56:48,880 --> 02:56:51,080
TO ARTICULATE.

4543
02:56:51,080 --> 02:56:52,720
THE UNKNOWN UNKNOWNS SUFFER.

4544
02:56:52,720 --> 02:56:57,080
WENDY, YOUR HAND IS UP.

4545
02:56:57,080 --> 02:57:01,520
>> YEAH, WITH THIS PANEL
OF

4546
02:57:01,520 --> 02:57:02,080
IMPLEMENTATION SCIENTISTS I

4547
02:57:02,080 --> 02:57:04,480
WANTED TO ASK A QUESTION THAT

4548
02:57:04,480 --> 02:57:05,680
COMES UP FREQUENTLY IN PEER

4549
02:57:05,680 --> 02:57:07,840
REVIEW OF THE TYPES OF

4550
02:57:07,840 --> 02:57:09,320
APPLICATIONS AS WELL AS

4551
02:57:09,320 --> 02:57:10,400
SOMETHING WE STRUGGLE WITH WHEN

4552
02:57:10,400 --> 02:57:15,160
WE LOOK AT THESE APPLICATIONS

4553
02:57:15,160 --> 02:57:16,320
PROGRAMATICALLY WHICH IS, YOU

4554
02:57:16,320 --> 02:57:20,040
KNOW, OFTEN WHEN I TALK TO

4555
02:57:20,040 --> 02:57:21,120
INVESTIGATORS ABOUT SUBMITTING

4556
02:57:21,120 --> 02:57:23,520
APPLICATIONS WE WANT THERE TO BE

4557
02:57:23,520 --> 02:57:25,960
AN EVIDENCE BASE BEFORE WE'RE

4558
02:57:25,960 --> 02:57:30,880
IMPLEMENTING INTERVENTIONS IN

4559
02:57:30,880 --> 02:57:35,840
HEALTH CARE DELIVERY SAYS  --

4560
02:57:35,840 --> 02:57:36,400
SYSTEMS.

4561
02:57:36,400 --> 02:57:37,920
WE TALK ABOUT ADAPTATIONS.

4562
02:57:37,920 --> 02:57:40,400
THE QUESTION THAT COMES UP HOW

4563
02:57:40,400 --> 02:57:45,120
MUCH ADAPTATION BEFORE YOU GOT A

4564
02:57:45,120 --> 02:57:46,120
NEW INTERVENTION, BEFORE WE

4565
02:57:46,120 --> 02:57:49,200
SHOULD REALLY BE PUTTING IT INTO

4566
02:57:49,200 --> 02:57:49,960
HEALTH CARE DELIVERY SYSTEMS.

4567
02:57:49,960 --> 02:57:51,320
DO YOU HAVE GUIDANCE FOR

4568
02:57:51,320 --> 02:57:53,400
INVESTIGATORS AS THEY ARE

4569
02:57:53,400 --> 02:57:54,520
THINKING ABOUT THIS?

4570
02:57:54,520 --> 02:57:57,600
OR EVEN GUIDANCE FOR US ACROSS

4571
02:57:57,600 --> 02:58:00,080
NIH AS WORK THINKING ABOUT HOW

4572
02:58:00,080 --> 02:58:04,360
TO WORK WITH THESE APPLICATIONS

4573
02:58:04,360 --> 02:58:06,280
AND THE EVIDENCE THAT DOESN'T

4574
02:58:06,280 --> 02:58:07,200
PERTAIN TO WHAT THEY ARE

4575
02:58:07,200 --> 02:58:16,080
PROPOSING IN THE NEXT STEP?

4576
02:58:16,080 --> 02:58:17,720
>> SO LOOKING AT MY
COLLEAGUES,

4577
02:58:17,720 --> 02:58:19,680
IF ANYONE WANTED TO GO OFF

4578
02:58:19,680 --> 02:58:21,760
BEFORE I DID, SO GREAT QUESTION,

4579
02:58:21,760 --> 02:58:22,320
WENDY.

4580
02:58:22,320 --> 02:58:24,720
I'LL GIVE A COUPLE THOUGHTS AND

4581
02:58:24,720 --> 02:58:28,040
THEN TISHA AND WYNNE MAY WANT TO

4582
02:58:28,040 --> 02:58:29,240
CORRECT MINE.

4583
02:58:29,240 --> 02:58:31,040
IT DOES DEPEND OBVIOUSLY.

4584
02:58:31,040 --> 02:58:34,280
PART OF IT IS AT TIMES WE MAY DO

4585
02:58:34,280 --> 02:58:36,080
OURSELVES A DISSERVICE BY NOT

4586
02:58:36,080 --> 02:58:37,880
SPECIFYING WHAT WE SEE AS THE

4587
02:58:37,880 --> 02:58:40,040
MECHANISMS OF ACTION WITHIN OUR

4588
02:58:40,040 --> 02:58:41,800
INTERVENTIONS, WHAT WE SEE AS

4589
02:58:41,800 --> 02:58:42,800
CORE COMPONENTS, PULLING

4590
02:58:42,800 --> 02:58:45,200
TOGETHER A PACKAGE WITHOUT A

4591
02:58:45,200 --> 02:58:46,080
GOOD SENSE OF MINIMAL

4592
02:58:46,080 --> 02:58:50,640
INTERVENTION NEEDED TO CHANGE OR

4593
02:58:50,640 --> 02:58:53,760
IS THIS SCOPED AS FRAMEWORK FOR

4594
02:58:53,760 --> 02:58:54,720
IMPLEMENTATION RESEARCH MODEL

4595
02:58:54,720 --> 02:58:59,560
SAYS  AROUND CORE COMPONENTS AND

4596
02:58:59,560 --> 02:59:00,400
ADAPTABLE PERIPHERY.

4597
02:59:00,400 --> 02:59:03,680
I WOULD SAY GOING IN WHEN WE'RE

4598
02:59:03,680 --> 02:59:07,080
DEVELOPING AND WE'RE TESTING OUR

4599
02:59:07,080 --> 02:59:08,000
INTERVENTIONS, WE'RE DOING IT

4600
02:59:08,000 --> 02:59:10,840
WITH AN EYE TOWARD WHAT IS

4601
02:59:10,840 --> 02:59:11,880
ESSENTIAL AND WHAT ARE THINGS

4602
02:59:11,880 --> 02:59:18,040
THAT MAY BE FLEXIBLY ADAPTED.

4603
02:59:18,040 --> 02:59:19,480
WITHIN REVIEW COMMITTEES OR

4604
02:59:19,480 --> 02:59:21,000
APPLICATIONS, HOW WE DEAL WITH

4605
02:59:21,000 --> 02:59:23,960
THIS SORT OF CONSISTENCY VERSUS

4606
02:59:23,960 --> 02:59:25,160
ADAPTATION TO SOME DEGREE GIVES

4607
02:59:25,160 --> 02:59:27,800
US A CHANCE TO THINK THROUGH IS

4608
02:59:27,800 --> 02:59:32,280
AN AN OPPORTUNITY FOR HYBRID

4609
02:59:32,280 --> 02:59:34,160
DESIGNS WHERE WE'RE ABLE TO ASK

4610
02:59:34,160 --> 02:59:35,520
QUESTIONS ABOUT EFFECTIVENESS OF

4611
02:59:35,520 --> 02:59:36,880
INTERVENTION, WHETHER THERE'S A

4612
02:59:36,880 --> 02:59:39,400
LOT OF ADAPTATION, A LOT OF

4613
02:59:39,400 --> 02:59:40,480
FLEXIBILITY, AND AT THE SAME

4614
02:59:40,480 --> 02:59:43,440
TIME TO FOCUS ON IF IT'S BEING

4615
02:59:43,440 --> 02:59:45,400
IMPLEMENTED HOW DO WE UNDERSTAND

4616
02:59:45,400 --> 02:59:46,160
THE EFFECTIVENESS OF DIFFERENT

4617
02:59:46,160 --> 02:59:47,560
STRATEGIES TO GET IT INTO PLAY.

4618
02:59:47,560 --> 02:59:49,520
I WOULD SAY THE LAST THING I'D

4619
02:59:49,520 --> 02:59:51,120
SAY IS PART OF IT IS A

4620
02:59:51,120 --> 02:59:53,080
PERSPECTIVE OF WHO IS MAKING THE

4621
02:59:53,080 --> 02:59:54,160
DECISION, IF I'M MAKING THE

4622
02:59:54,160 --> 02:59:56,000
DECISION THAT THIS IS SORT OF

4623
02:59:56,000 --> 02:59:57,760
READY TO BE IMPLEMENTED THEN I

4624
02:59:57,760 --> 03:00:00,440
NEED TO JUSTIFY THE EVIDENCE IS

4625
03:00:00,440 --> 03:00:01,600
THERE, THAT THIS IS INTERVENTION

4626
03:00:01,600 --> 03:00:04,760
THE WAY IT'S BEING DEFINED IS

4627
03:00:04,760 --> 03:00:05,120
EFFECTIVE.

4628
03:00:05,120 --> 03:00:08,600
IF I'M ABLE TO EVALUATE WHAT IS

4629
03:00:08,600 --> 03:00:09,840
HAPPENING ANYWAY, THAT MAY GIVE

4630
03:00:09,840 --> 03:00:12,280
ME A LITTLE BIT MORE FLEXIBILITY

4631
03:00:12,280 --> 03:00:16,440
NOT TO HAVE TO DICTATE THIS

4632
03:00:16,440 --> 03:00:18,280
LOOKS THE SAME BUT THE

4633
03:00:18,280 --> 03:00:21,600
SCIENTIFIC ENDEAVOR IS TO

4634
03:00:21,600 --> 03:00:24,120
UNDERSTAND HOW DIFFERENT

4635
03:00:24,120 --> 03:00:24,920
PERMUTATIONS WHEN IMPLEMENTED BY

4636
03:00:24,920 --> 03:00:26,400
OTHERS MAY HAVE POSITIVE OR

4637
03:00:26,400 --> 03:00:27,080
NEGATIVE EFFECT.

4638
03:00:27,080 --> 03:00:28,760
JUST A FEW THINGS ON THE TABLE.

4639
03:00:28,760 --> 03:00:30,880
>> I'LL JUST ADD A COUPLE

4640
03:00:30,880 --> 03:00:31,240
THINGS HERE.

4641
03:00:31,240 --> 03:00:34,000
IT'S A GREAT QUESTION.

4642
03:00:34,000 --> 03:00:36,400
I THINK REFERRING BACK TO SOME

4643
03:00:36,400 --> 03:00:39,200
DISCUSSIONS EARLIER TODAY AROUND

4644
03:00:39,200 --> 03:00:40,760
FORM AND FUNCTION, SOME WORK

4645
03:00:40,760 --> 03:00:43,600
BRIAN HAS BEEN LEADING TRYING TO

4646
03:00:43,600 --> 03:00:44,800
SPECIFY PARTICULARLY FOR

4647
03:00:44,800 --> 03:00:45,560
INTERVENTIONS WITH MULTIPLE

4648
03:00:45,560 --> 03:00:48,040
COMPONENTS, SO WHAT MIGHT YOU

4649
03:00:48,040 --> 03:00:50,480
IMAGINE WOULD CHANGE IN TERMS OF

4650
03:00:50,480 --> 03:00:53,720
THE FORM IT MIGHT TAKE VERSUS

4651
03:00:53,720 --> 03:00:55,080
KEEPING TRUE TO THE FUNCTION AND

4652
03:00:55,080 --> 03:00:58,280
HOW AND WHY THAT IS PROPOSED TO

4653
03:00:58,280 --> 03:01:00,320
ACTUALLY HAVE AN EFFECT.

4654
03:01:00,320 --> 03:01:02,760
I THINK ALSO TRACKING

4655
03:01:02,760 --> 03:01:06,120
ADAPTATIONS IS REALLY IMPORTANT,

4656
03:01:06,120 --> 03:01:07,560
SO ANTICIPATING WHAT ADAPTATIONS

4657
03:01:07,560 --> 03:01:09,320
MIGHT BE, HAVING A STRUCTURE IN

4658
03:01:09,320 --> 03:01:11,160
PLACE IN THE APPLICATION AS WELL

4659
03:01:11,160 --> 03:01:12,360
AS PRACTICALLY WITHIN YOUR TRIAL

4660
03:01:12,360 --> 03:01:14,120
WHAT ARE SOME ADAPTATIONS THAT

4661
03:01:14,120 --> 03:01:15,320
MIGHT OCCUR, HOW YOU TRACK THAT

4662
03:01:15,320 --> 03:01:18,280
OVER TIME AND WE ALSO HAVE SOME

4663
03:01:18,280 --> 03:01:25,280
WORK AROUND EMERGING WORK AROUND

4664
03:01:25,280 --> 03:01:27,960
TRACKING ADAPTATIONS TO

4665
03:01:27,960 --> 03:01:29,760
IMPLEMENTATION STRATEGIES.

4666
03:01:29,760 --> 03:01:33,160
TO THE EXTENT APPLICANTS CAN

4667
03:01:33,160 --> 03:01:35,360
REFER TO EXISTING FRAMEWORK,

4668
03:01:35,360 --> 03:01:38,120
SPECIFYING WHAT INTERVENTION

4669
03:01:38,120 --> 03:01:40,080
ADAPTATIONS ARE FRAMED BY

4670
03:01:40,080 --> 03:01:41,520
SHANNON STERNMAN, HAPPY TO SHARE

4671
03:01:41,520 --> 03:01:43,120
IN THE CHAT OR AFTERWARD,

4672
03:01:43,120 --> 03:01:51,440
REFERRING TO THAT AND

4673
03:01:51,440 --> 03:01:53,840
IDENTIFYING TYPES OF ADAPTATION,

4674
03:01:53,840 --> 03:01:55,960
WHAT'S IN SCOPE, WHAT'S

4675
03:01:55,960 --> 03:01:56,600
CONSIDERED DIFFERENT, I DON'T

4676
03:01:56,600 --> 03:01:59,120
KNOW IF THIS IS DIFFERENT AND

4677
03:01:59,120 --> 03:02:00,760
NEEDS MORE EFFICACY VERSUS THIS

4678
03:02:00,760 --> 03:02:03,920
IS STILL WITHIN SCOPE BUT AGAIN

4679
03:02:03,920 --> 03:02:08,640
I THINK IN GRANTSMANSHIP TO

4680
03:02:08,640 --> 03:02:09,600
ANTICIPATE AND ACKNOWLEDGE WHO

4681
03:02:09,600 --> 03:02:15,760
IS GUIDING THE DECISION AROUND

4682
03:02:15,760 --> 03:02:18,160
ADAPTATION IS REALLY IMPORTANT.

4683
03:02:18,160 --> 03:02:22,000
>> I'LL JUST ECHO SOME

4684
03:02:22,000 --> 03:02:23,040
COMMENTS, IT'S A GREAT QUESTION

4685
03:02:23,040 --> 03:02:25,400
AND A TOUGH ONE.

4686
03:02:25,400 --> 03:02:29,000
I THINK IT IS A PLACE FOR MORE

4687
03:02:29,000 --> 03:02:34,480
OF HYBRID DESIGNS AND WE WOULD

4688
03:02:34,480 --> 03:02:35,920
DO WELL TO USE HYBRID DESIGNS

4689
03:02:35,920 --> 03:02:37,320
EARLY ON EVEN DOING EFFICACY

4690
03:02:37,320 --> 03:02:39,400
WORK, MAYBE NOT VERY EARLY

4691
03:02:39,400 --> 03:02:41,480
STAGES BUT WE SEE A LOT, AT NIDA

4692
03:02:41,480 --> 03:02:43,800
WE HAVE THE QUIRK WHERE WE

4693
03:02:43,800 --> 03:02:45,320
DIVIDE OUR TREATMENT DEVELOPMENT

4694
03:02:45,320 --> 03:02:47,080
AND THEN OUR SERVICES RESEARCH

4695
03:02:47,080 --> 03:02:50,120
SO WE HAVE THIS ACROSS DIFFERENT

4696
03:02:50,120 --> 03:02:52,000
DIVISIONS, WE HAVE THIS WEIRD

4697
03:02:52,000 --> 03:02:52,200
DIVIDE.

4698
03:02:52,200 --> 03:02:54,240
I DON'T THINK IT SERVES THE

4699
03:02:54,240 --> 03:02:56,800
SCIENCE WELL BECAUSE IT IS THESE

4700
03:02:56,800 --> 03:02:59,320
QUESTIONS, IS THIS A CHANGE THAT

4701
03:02:59,320 --> 03:03:00,520
IS FUNDAMENTAL, IS TAKING US

4702
03:03:00,520 --> 03:03:02,080
BACK TO THE EARLIER STAGE?

4703
03:03:02,080 --> 03:03:03,880
OR IS THIS A CHANGE THAT'S

4704
03:03:03,880 --> 03:03:06,760
REALLY ABOUT PUTTING TOGETHER

4705
03:03:06,760 --> 03:03:07,720
EVIDENCE BASED COMPONENTS, AND

4706
03:03:07,720 --> 03:03:08,920
WE'RE MAKING SURE IT WORKS AND

4707
03:03:08,920 --> 03:03:12,320
WE'RE DOING SO IN A WAY THAT IS

4708
03:03:12,320 --> 03:03:14,840
SMART, WHAT ARE THE CORE

4709
03:03:14,840 --> 03:03:16,480
COMPONENTS, WHAT IS MINIMUM

4710
03:03:16,480 --> 03:03:17,920
VIABLE INTERVENTION THAT WILL

4711
03:03:17,920 --> 03:03:18,960
PRODUCE OUR OUTCOME?

4712
03:03:18,960 --> 03:03:23,480
WE SEE A LOT OF IT.

4713
03:03:23,480 --> 03:03:25,160
I THINK THAT THE HYBRID DESIGNS

4714
03:03:25,160 --> 03:03:26,880
CAN BE MORE EFFICIENT WITH THE

4715
03:03:26,880 --> 03:03:28,440
WAY WE MAKE THESE INVESTMENT IN

4716
03:03:28,440 --> 03:03:31,040
THE CORE COMPONENT THINKING

4717
03:03:31,040 --> 03:03:32,040
ABOUT WHY WOULD THIS PIECE NOT

4718
03:03:32,040 --> 03:03:34,640
WORK AND WHAT ARE WE ADAPTING

4719
03:03:34,640 --> 03:03:36,720
AND FOR WHAT PURPOSES, SO, YEAH,

4720
03:03:36,720 --> 03:03:37,880
IT'S A TOUGH QUESTION.

4721
03:03:37,880 --> 03:03:45,560
THERE'S MANY SHADES OF GRAY IN

4722
03:03:45,560 --> 03:03:46,280
THIS SPACE.

4723
03:03:46,280 --> 03:03:47,120
>> OKAY.

4724
03:03:47,120 --> 03:03:47,520
GREAT.

4725
03:03:47,520 --> 03:03:53,000
AN INTERESTING PLACE TO BE.

4726
03:03:53,000 --> 03:03:54,600
WENDY WAS SURMISING PRIVATELY ON

4727
03:03:54,600 --> 03:04:01,360
THE CHAT -- I'M GLAD YOU CAME

4728
03:04:01,360 --> 03:04:02,240
BACK, WENDY.

4729
03:04:02,240 --> 03:04:04,520
WENDY WAS FEEDING ME QUESTIONS

4730
03:04:04,520 --> 03:04:07,040
BUT YOU SHOULD ASK THEM ON YOUR

4731
03:04:07,040 --> 03:04:07,240
OWN.

4732
03:04:07,240 --> 03:04:08,280
>> SURE.

4733
03:04:08,280 --> 03:04:12,200
SO WE HAVE A FEW OF OUR

4734
03:04:12,200 --> 03:04:14,680
INVESTIGATORS AND A COUPLE

4735
03:04:14,680 --> 03:04:16,120
HEALTH CARE SYSTEM PARTNERS ON

4736
03:04:16,120 --> 03:04:18,200
THE PANEL AS WELL.

4737
03:04:18,200 --> 03:04:19,840
AND, YOU KNOW, ONE QUESTION THAT

4738
03:04:19,840 --> 03:04:23,120
I WOULD ASK TO YOU AS

4739
03:04:23,120 --> 03:04:23,760
INVESTIGATORS IS, YOU KNOW, WHAT

4740
03:04:23,760 --> 03:04:27,280
DO YOU WISH YOU COULD HAVE ASKED

4741
03:04:27,280 --> 03:04:27,720
NIH?

4742
03:04:27,720 --> 03:04:31,320
WHEN THINGS WEREN'T GOING AS

4743
03:04:31,320 --> 03:04:33,200
PLANNED WHAT DO YOU -- WHAT DID

4744
03:04:33,200 --> 03:04:34,760
YOU WANT TO ASK, MAYBE YOU

4745
03:04:34,760 --> 03:04:36,120
DIDN'T, WHAT DO YOU WISH COULD

4746
03:04:36,120 --> 03:04:37,680
YOU HAVE DONE WHEN THINGS

4747
03:04:37,680 --> 03:04:38,760
WEREN'T EXACTLY GOING AS

4748
03:04:38,760 --> 03:04:40,520
PLANNED?

4749
03:04:40,520 --> 03:04:43,880
WE HAVE A COUPLE OF, YOU KNOW,

4750
03:04:43,880 --> 03:04:45,240
INVESTIGATORS STILL IN THE MIDST

4751
03:04:45,240 --> 03:04:47,280
OF THEIR TRIALS, MAY NOT WANT TO

4752
03:04:47,280 --> 03:04:49,280
BE FORTHCOMING BUT MAYBE YOUR

4753
03:04:49,280 --> 03:04:52,440
PREVIOUS TRIALS, MAYBE WHEN YOU

4754
03:04:52,440 --> 03:04:55,280
HAD OTHER SENDERS, OTHER THINGS

4755
03:04:55,280 --> 03:04:57,200
YOU WISH YOU COULD ENGAGE IN

4756
03:04:57,200 --> 03:04:58,320
MORE CONVERSATION OR DO YOU

4757
03:04:58,320 --> 03:05:01,200
THINK THE STRUCTURE OF THE

4758
03:05:01,200 --> 03:05:03,040
COLLABORATORY WHERE WE HAD TO

4759
03:05:03,040 --> 03:05:04,360
MAKE CHANGES DURING COVID SO I

4760
03:05:04,360 --> 03:05:06,120
DON'T KNOW IF ANY OF OUR

4761
03:05:06,120 --> 03:05:09,920
INVESTIGATORS WANT TO MAYBE TALK

4762
03:05:09,920 --> 03:05:11,040
ABOUT, YOU KNOW, WHEN DID YOU

4763
03:05:11,040 --> 03:05:14,960
DECIDE TO MAYBE EVEN HAVE THAT

4764
03:05:14,960 --> 03:05:17,280
CONVERSATION WITH NIH, AND HAVE

4765
03:05:17,280 --> 03:05:19,480
THOSE DISCUSSIONS TO THINK ABOUT

4766
03:05:19,480 --> 03:05:27,080
MAKING SOME ADAPTATIONS AND

4767
03:05:27,080 --> 03:05:31,080
CHANGES? 

4768
03:05:31,080 --> 03:05:33,800
I KNOW NATALIA AND I HAD MANY

4769
03:05:33,800 --> 03:05:34,960
CONVERSATIONS OF THINGS WERE NOT

4770
03:05:34,960 --> 03:05:37,280
GOING SO WELL, THINGS WERE

4771
03:05:37,280 --> 03:05:39,600
CHANGING ALL AROUND YOU MAYBE IS

4772
03:05:39,600 --> 03:05:43,640
A BETTER WAY TO NAUGHT.

4773
03:05:43,640 --> 03:05:45,960
>> THIS IS RELEVANT TO
WHAT YOU

4774
03:05:45,960 --> 03:05:47,160
JUST ASKED, WENDY.

4775
03:05:47,160 --> 03:05:50,440
DAVID HAD MENTIONED THERE MIGHT

4776
03:05:50,440 --> 03:05:54,520
BE FEAR TO ENGAGE BY P.I.s

4777
03:05:54,520 --> 03:05:56,240
WITH THEIR PROGRAM OFFICERS.

4778
03:05:56,240 --> 03:05:58,680
IN SOME WAYS A WAY TO

4779
03:05:58,680 --> 03:06:02,360
OPERATIONALIZE IT, TO TAKE AWAY

4780
03:06:02,360 --> 03:06:04,800
THAT EMOTIONAL COMPONENT WOULD

4781
03:06:04,800 --> 03:06:05,560
BE HELPFUL.

4782
03:06:05,560 --> 03:06:14,640
JUST KIND OF A POLICY.

4783
03:06:14,640 --> 03:06:16,640
I'M ALSO A PERSON TO JUST JUMPS

4784
03:06:16,640 --> 03:06:18,160
OFF A CLIFF, I KNOW I HAD TO

4785
03:06:18,160 --> 03:06:20,840
TALK TO YOU SOONER RATHER THAN

4786
03:06:20,840 --> 03:06:23,000
LATER BUT THE FEAR WAS REAL,

4787
03:06:23,000 --> 03:06:24,280
YES, WE WERE UNDER EMERGENCY

4788
03:06:24,280 --> 03:06:25,400
CIRCUMSTANCES WITH THE PANDEMIC

4789
03:06:25,400 --> 03:06:27,280
BUT THE FEAR WAS REAL BECAUSE

4790
03:06:27,280 --> 03:06:33,840
THIS WAS A REALLY DRAMATIC

4791
03:06:33,840 --> 03:06:35,160
CHANGE TO OUR INTERVENTION.

4792
03:06:35,160 --> 03:06:38,960
THE WORK THE WAY DAVID SAID.

4793
03:06:38,960 --> 03:06:39,840
I DIDN'T HEAR THAT AT THE TIME

4794
03:06:39,840 --> 03:06:42,920
BUT YOU WERE THE WAY HE SAID,

4795
03:06:42,920 --> 03:06:44,360
THAT YOU WOULD BEHAVE.

4796
03:06:44,360 --> 03:06:46,840
YOU DID LISTEN AND REALLY HELPED

4797
03:06:46,840 --> 03:06:49,600
US WORK THIS THROUGH, CONNECTED

4798
03:06:49,600 --> 03:06:51,000
US WITH THE COLLABORATORY, SO

4799
03:06:51,000 --> 03:06:52,800
THERE WERE A LOT OF -- THERE WAS

4800
03:06:52,800 --> 03:06:54,880
A LOT OF DISCUSSION.

4801
03:06:54,880 --> 03:07:05,400
IT WASN'T A UNILATERAL DECISION,

4802
03:07:05,760 --> 03:07:11,720
HAD TO THROUGH DSMB, NICCH. 

4803
03:07:11,720 --> 03:07:16,320
I TOOK AN AMOUNT OF COURAGE, I

4804
03:07:16,320 --> 03:07:18,280
WISH IT WAS MADE THAT IT WAS

4805
03:07:18,280 --> 03:07:19,480
OKAY TO APPROACH EARLY SO THAT

4806
03:07:19,480 --> 03:07:26,840
IT COULD BE ADDRESSED SOONER.

4807
03:07:26,840 --> 03:07:27,080
>> GREAT.

4808
03:07:27,080 --> 03:07:29,320
KEN, YOU WERE NEXT TO LIGHT UP.

4809
03:07:29,320 --> 03:07:33,640
>> I SEE ED HAS A HAND
UP, I'LL

4810
03:07:33,640 --> 03:07:37,680
LET HIM GO FIRST.

4811
03:07:37,680 --> 03:07:37,840
ED?

4812
03:07:37,840 --> 03:07:43,240
>> OH, OUR TRIAL WAS
PRE-COVID.

4813
03:07:43,240 --> 03:07:47,760
AND WE MET I THINK IT WAS RICH

4814
03:07:47,760 --> 03:07:49,720
AND ROD CALIFF WERE THE

4815
03:07:49,720 --> 03:07:51,600
CO-CHAIRS OF THAT, RIGHT, RICH?

4816
03:07:51,600 --> 03:07:53,080
>> YEP, THERE WAS A TIME.

4817
03:07:53,080 --> 03:07:58,040
>> THERE WAS A TIME,
YEAH.

4818
03:07:58,040 --> 03:08:01,760
ROD HAS GONE ON TO BE FDA

4819
03:08:01,760 --> 03:08:02,040
DIRECTOR.

4820
03:08:02,040 --> 03:08:05,040
I WANT TO SAY SOMETHING

4821
03:08:05,040 --> 03:08:06,680
POSITIVE, SUES AND I WENT TO ALL

4822
03:08:06,680 --> 03:08:08,480
THE MEETINGS, FOR THE FIVE OR

4823
03:08:08,480 --> 03:08:11,160
SIX YEARS WE DID THIS I CAN ONLY

4824
03:08:11,160 --> 03:08:14,360
SPEAK FOR MYSELF, I THINK SUSAN

4825
03:08:14,360 --> 03:08:15,680
WOULD AGREE, I LEARNED SO MUCH

4826
03:08:15,680 --> 03:08:17,760
FROM ALL OF YOU.

4827
03:08:17,760 --> 03:08:20,240
IT WAS AN INCREDIBLE EXPERIENCE.

4828
03:08:20,240 --> 03:08:22,360
I WISH WE COULD REPLICATE IT NOW

4829
03:08:22,360 --> 03:08:27,720
POST-COVID. 

4830
03:08:27,720 --> 03:08:29,640
THAT'S JUST MY ANSWER.

4831
03:08:29,640 --> 03:08:37,320
>> OKAY, KEN, , YOU CAN
HAVE TE

4832
03:08:37,320 --> 03:08:38,600
FINAL COMMENT.

4833
03:08:38,600 --> 03:08:40,280
>> I WASN'T THERE AT THE

4834
03:08:40,280 --> 03:08:43,760
BEGINNING OF ABATE BUT I WOULD

4835
03:08:43,760 --> 03:08:46,920
SAY, AGAIN, IT COMES DOWN TO THE

4836
03:08:46,920 --> 03:08:52,640
PARTNERSHIP AND THE FACT WE HAVE

4837
03:08:52,640 --> 03:08:56,160
A GOOD RELATIONSHIP WITH THE

4838
03:08:56,160 --> 03:08:58,000
RESEARCH TEAM AT HARVARD, AND

4839
03:08:58,000 --> 03:09:00,080
THAT THAT GROUP AS A GOOD

4840
03:09:00,080 --> 03:09:03,800
RELATIONSHIP WITH NIH THAT IS

4841
03:09:03,800 --> 03:09:05,320
I -- IT ALLOWED THE APPROPRIATE

4842
03:09:05,320 --> 03:09:09,400
BACK AND FORTH IN TERMS OF

4843
03:09:09,400 --> 03:09:10,480
QUESTIONS.

4844
03:09:10,480 --> 03:09:13,200
AND THE ABILITY TO APPROACH THE

4845
03:09:13,200 --> 03:09:15,920
FUNDERS IN TERMS OF RESEARCH

4846
03:09:15,920 --> 03:09:17,480
STUDIES, SO I'M GLAD ED HAD

4847
03:09:17,480 --> 03:09:19,320
COMMENTS BECAUSE HE WAS CLOSER

4848
03:09:19,320 --> 03:09:22,080
TO THE FRONT END OF THIS STUDY.

4849
03:09:22,080 --> 03:09:25,000
BUT I THINK IT DOES GET BACK TO

4850
03:09:25,000 --> 03:09:26,000
PARTNERSHIP AS BEING AN

4851
03:09:26,000 --> 03:09:28,600
IMPORTANT ELEMENT OF BEING ABLE

4852
03:09:28,600 --> 03:09:32,040
TO PROBLEM SOLVE ALONG THE WAY.

4853
03:09:32,040 --> 03:09:36,840
>> YEAH, IT IS -- I'LL
JUST SAY

4854
03:09:36,840 --> 03:09:40,240
SINCE I'M MOST OFTEN INTERACTING

4855
03:09:40,240 --> 03:09:44,840
WITH NIH AS RECIPIENT OF

4856
03:09:44,840 --> 03:09:45,480
FUNDING, THAT RELATIONSHIP MAKES

4857
03:09:45,480 --> 03:09:50,320
IT TOUGH TO BE FULLY CANDID.

4858
03:09:50,320 --> 03:09:52,480
YOU KNOW, IT TAKES YEARS AND

4859
03:09:52,480 --> 03:09:58,520
YEARS OF TRUST, AND EVEN SO IT'S

4860
03:09:58,520 --> 03:09:59,560
A BIG ASK.

4861
03:09:59,560 --> 03:10:03,720
GLORIA, DO YOU WANT TO WEIGH IN?

4862
03:10:03,720 --> 03:10:06,480
>> YEAH, I THINK YOU'RE
RIGHT

4863
03:10:06,480 --> 03:10:07,440
ON, RICH.

4864
03:10:07,440 --> 03:10:10,640
I WOULD SAY JUST BUILDING ON

4865
03:10:10,640 --> 03:10:16,240
WHAT NATALIA SAID, I WOULD SAY

4866
03:10:16,240 --> 03:10:18,000
ONE OF THE THINGS WE APPRECIATED

4867
03:10:18,000 --> 03:10:19,640
WAS THE INFRASTRUCTURE AND

4868
03:10:19,640 --> 03:10:20,720
SUPPORT OF COORDINATING CENTER.

4869
03:10:20,720 --> 03:10:22,480
AND SO, YOU KNOW, OUR

4870
03:10:22,480 --> 03:10:24,880
STATISTICIAN MET WITH THE OTHER

4871
03:10:24,880 --> 03:10:26,400
STATISTICIANS FROM THE OTHER

4872
03:10:26,400 --> 03:10:28,920
PROJECTS, THERE WAS REVIEW OF

4873
03:10:28,920 --> 03:10:30,680
ALL OF THE STATISTICAL ANALYSIS

4874
03:10:30,680 --> 03:10:35,280
PLANS OF ALL THE FUNDED

4875
03:10:35,280 --> 03:10:36,920
PROJECTS, AND I APPRECIATED KIND

4876
03:10:36,920 --> 03:10:41,760
OF THAT TYPE OF INFRASTRUCTURE

4877
03:10:41,760 --> 03:10:44,240
THAT REALLY KIND OF, YOU KNOW,

4878
03:10:44,240 --> 03:10:46,200
REVIEWED PROJECTS IN ADVANCE AND

4879
03:10:46,200 --> 03:10:48,280
DID ADDITIONAL REVIEWS AND KIND

4880
03:10:48,280 --> 03:10:49,400
OF THOUGHT THROUGH YOUR METHODS.

4881
03:10:49,400 --> 03:10:52,560
WE WERE IN A SITUATION WHERE WE

4882
03:10:52,560 --> 03:10:55,400
WERE ABOUT TO PUBLISH, AND THERE

4883
03:10:55,400 --> 03:10:58,720
WAS AN ERROR IN OUR PROGRAM THAT

4884
03:10:58,720 --> 03:11:00,880
WAS FOUND BY THAT STATISTICAL

4885
03:11:00,880 --> 03:11:04,800
GROUP, AND SO WE REALLY

4886
03:11:04,800 --> 03:11:06,120
BENEFITED THROUGHOUT BY HAVING

4887
03:11:06,120 --> 03:11:07,000
THAT TYPE OF INFRASTRUCTURE THAT

4888
03:11:07,000 --> 03:11:09,400
MADE IT SO IT WASN'T AS

4889
03:11:09,400 --> 03:11:11,880
CHALLENGING TO TALK ABOUT THE

4890
03:11:11,880 --> 03:11:12,960
ISSUES THAT YOU ARE ENCOUNTERING

4891
03:11:12,960 --> 03:11:15,320
BECAUSE YOU WERE IN A GROUP OF

4892
03:11:15,320 --> 03:11:18,160
PEERS AND SO I JUST WANTED TO

4893
03:11:18,160 --> 03:11:19,360
SHOUT OUT TO THE COORDINATING

4894
03:11:19,360 --> 03:11:21,560
CENTER FOR THAT TYPE OF

4895
03:11:21,560 --> 03:11:21,920
INFRASTRUCTURE.

4896
03:11:21,920 --> 03:11:25,720
I WILL SAY THAT I'M BEEN FUNDED

4897
03:11:25,720 --> 03:11:29,880
ON OTHER U PROJECTS, PART OF

4898
03:11:29,880 --> 03:11:31,000
CONSORTIUMS, PEOPLE SAID WE GET

4899
03:11:31,000 --> 03:11:32,840
A CHANCE TO WORK WITH THE

4900
03:11:32,840 --> 03:11:34,240
STATISTICIANS AND THEY SAID

4901
03:11:34,240 --> 03:11:35,920
ABSOLUTELY NOT, LIKE WE DON'T DO

4902
03:11:35,920 --> 03:11:40,040
THAT, WE WOULD NEVER ADVISE ON A

4903
03:11:40,040 --> 03:11:41,240
PROJECT BECAUSE THOSE ARE

4904
03:11:41,240 --> 03:11:42,480
DECISIONS THAT SHOULD BE MADE AT

4905
03:11:42,480 --> 03:11:44,320
THE PROJECT LEVEL SO I'VE ALSO

4906
03:11:44,320 --> 03:11:47,160
HAD TO NAVIGATE AND CHANGE

4907
03:11:47,160 --> 03:11:48,160
EXPECTATIONS BECAUSE NOT ALL

4908
03:11:48,160 --> 03:11:51,000
PROJECTS ARE RUN WITH THIS TYPE

4909
03:11:51,000 --> 03:11:52,840
OF FULL SERVICE COORDINATING

4910
03:11:52,840 --> 03:11:53,400
CENTER.

4911
03:11:53,400 --> 03:11:54,680
SO ANOTHER COMPLIMENT THAT I

4912
03:11:54,680 --> 03:11:56,280
THINK THOSE TYPES OF -- THAT

4913
03:11:56,280 --> 03:11:58,120
TYPE OF INFRASTRUCTURE CAN

4914
03:11:58,120 --> 03:12:00,320
REALLY HELP WITH THE

4915
03:12:00,320 --> 03:12:01,520
RELATIONSHIPS, BECAUSE YOU HAVE

4916
03:12:01,520 --> 03:12:05,680
YOUR PEERS THEY ARE IN THE SAME

4917
03:12:05,680 --> 03:12:06,560
SITUATION, REFLECTING ON THE

4918
03:12:06,560 --> 03:12:10,080
CHALLENGES AND I DO FEEL LIKE

4919
03:12:10,080 --> 03:12:11,720
OUR GROUP WAS COMING ABOUT

4920
03:12:11,720 --> 03:12:13,240
CHALLENGES AS THEY WERE

4921
03:12:13,240 --> 03:12:17,600
OCCURRING ON THE STUDIES, REALLY

4922
03:12:17,600 --> 03:12:17,840
HELPFUL.

4923
03:12:17,840 --> 03:12:18,240
>> GREAT.

4924
03:12:18,240 --> 03:12:22,120
AND CORITA, DO YOU WANT TO

4925
03:12:22,120 --> 03:12:22,320
WEIGH?

4926
03:12:22,320 --> 03:12:27,680
>> JUST GRATEFUL FOR THE
HELP,

4927
03:12:27,680 --> 03:12:28,760
TO ECHO WHAT GLORIA JUST SAID,

4928
03:12:28,760 --> 03:12:30,960
IT'S KEY TO BE ABLE TO SHARE IN

4929
03:12:30,960 --> 03:12:36,000
AN HONEST WAY AND IT'S NICE TO

4930
03:12:36,000 --> 03:12:38,720
BE BACK, MY FIRST FACE-TO-FACE

4931
03:12:38,720 --> 03:12:40,400
MEETING OF THE COLLABORATORY,

4932
03:12:40,400 --> 03:12:41,720
LAST MONTH, TWO MONTHS AGO.

4933
03:12:41,720 --> 03:12:42,800
YEAH, NOTHING LIKE HAVING A

4934
03:12:42,800 --> 03:12:43,880
COMMUNITY YOU PEOPLE YOU CAN

4935
03:12:43,880 --> 03:12:47,840
TALK TO WHO ARE HAVING THE SAME

4936
03:12:47,840 --> 03:12:48,360
PROBLEMS YOU'RE HAVING.

4937
03:12:48,360 --> 03:12:49,480
>> TERRIFIC.

4938
03:12:49,480 --> 03:12:52,120
THIS IS THE PLACE TO DECLARE

4939
03:12:52,120 --> 03:12:54,320
VICTORY FOR THIS PANEL.

4940
03:12:54,320 --> 03:12:58,040
AND SO PANELISTS, THANK YOU,

4941
03:12:58,040 --> 03:13:01,040
REALLY, ON BEHALF OF EVERYONE,

4942
03:13:01,040 --> 03:13:02,600
REALLY APPRECIATE YOUR

4943
03:13:02,600 --> 03:13:04,480
THOUGHTFUL COMMENTS AND YOUR

4944
03:13:04,480 --> 03:13:06,000
PARTICIPATION.

4945
03:13:06,000 --> 03:13:11,480
WE HAVE A FEW MINUTES FOR

4946
03:13:11,480 --> 03:13:11,720
WRAP-UP.

4947
03:13:11,720 --> 03:13:13,760
THAT'S ADVERTISED ON THE PROGRAM

4948
03:13:13,760 --> 03:13:20,560
AS WENDY, KEVIN, AND RICH.

4949
03:13:20,560 --> 03:13:21,800
AND SO WE'RE NOT REQUIRED TO US

4950
03:13:21,800 --> 03:13:23,600
A ALL THE TIME BETWEEN NOW AND

4951
03:13:23,600 --> 03:13:24,160
2:00.

4952
03:13:24,160 --> 03:13:25,040
LET'S PRAY WE DON'T BECAUSE

4953
03:13:25,040 --> 03:13:29,640
OTHERWISE IT WILL BE JUST THE

4954
03:13:29,640 --> 03:13:31,840
THREE OF US.

4955
03:13:31,840 --> 03:13:36,760
IT'S TIME FOR EVERYONE TO WEIGH

4956
03:13:36,760 --> 03:13:39,160
IN.

4957
03:13:39,160 --> 03:13:44,560
SO, BY WAY OF SUMMARY, ONE OF

4958
03:13:44,560 --> 03:13:48,400
THE THINGS BY WAY OF SUMMARY, I

4959
03:13:48,400 --> 03:13:52,360
THINK ONE OF THE THINGS THAT WE

4960
03:13:52,360 --> 03:13:54,520
HAD BEEN -- HAD AS FRONT OF MIND

4961
03:13:54,520 --> 03:13:55,840
WHEN WE PUT THIS PROGRAM

4962
03:13:55,840 --> 03:14:02,520
TOGETHER WAS TO ASK HOW CAN

4963
03:14:02,520 --> 03:14:03,960
COLLABORATORY PROJECTS LEARN

4964
03:14:03,960 --> 03:14:06,440
FASTER AND I THINK WE

4965
03:14:06,440 --> 03:14:09,960
ACCOMPLISHED SOME OF THAT PART

4966
03:14:09,960 --> 03:14:13,680
OF WHAT, FOR ME, COME THROUGH

4967
03:14:13,680 --> 03:14:20,120
HOW MUCH THE COLLABORATORY HAS

4968
03:14:20,120 --> 03:14:23,080
FACILITATED BETTER, FASTER

4969
03:14:23,080 --> 03:14:24,160
LEARNING. 

4970
03:14:24,160 --> 03:14:24,960
MAYBE THAT'S NOT A SURPRISE BUT

4971
03:14:24,960 --> 03:14:26,560
IT SEEMS TO BE ONE OF THE

4972
03:14:26,560 --> 03:14:29,160
THROUGH LINES OF EIGHT HOURS OF

4973
03:14:29,160 --> 03:14:32,600
DISCUSSION IS REALIZING HOW MUCH

4974
03:14:32,600 --> 03:14:34,360
THE VERY SUBSTANTIAL INVESTMENT

4975
03:14:34,360 --> 03:14:38,120
THAT NIH HAS MADE IN THE

4976
03:14:38,120 --> 03:14:42,320
COLLABORATORY HAS CONTRIBUTED TO

4977
03:14:42,320 --> 03:14:43,760
THE COLLABORATORY PROJECT BEING

4978
03:14:43,760 --> 03:14:49,720
MORE SUCCESSFUL THAN THEY WOULD

4979
03:14:49,720 --> 03:14:50,320
HAVE BEEN.

4980
03:14:50,320 --> 03:14:51,280
WENDY, YOUR BEST POSITION TO SAY

4981
03:14:51,280 --> 03:14:56,560
HOW MUCH WHAT THE COLLABORATORY

4982
03:14:56,560 --> 03:15:01,320
IS DOING IS DIFFUSING MORE

4983
03:15:01,320 --> 03:15:04,320
BROADLY ACROSS THE AGENCY.

4984
03:15:04,320 --> 03:15:05,040
GO AHEAD.

4985
03:15:05,040 --> 03:15:07,440
>> YEAH, I THINK THE DAY
AND

4986
03:15:07,440 --> 03:15:09,080
I'M CURIOUS, LIKE YOU SAID,

4987
03:15:09,080 --> 03:15:11,920
RICH, THIS IS OPEN TO ANYBODY

4988
03:15:11,920 --> 03:15:13,160
WHO WANTS TO PROVIDE, SO MY

4989
03:15:13,160 --> 03:15:14,680
COMMENTS, WE HAVE LEARNED A LOT.

4990
03:15:14,680 --> 03:15:17,000
YOU KNOW, TRYING TO USE THESE

4991
03:15:17,000 --> 03:15:19,680
WORKSHOPS AS OPPORTUNITIES TO

4992
03:15:19,680 --> 03:15:21,400
SHARE THAT INFORMATION, I THINK

4993
03:15:21,400 --> 03:15:22,560
YESTERDAY, YOU KNOW, HEARING

4994
03:15:22,560 --> 03:15:26,600
FROM OUR HEALTH CARE SYSTEM

4995
03:15:26,600 --> 03:15:29,280
PARTNERS AND, YOU KNOW, THAT

4996
03:15:29,280 --> 03:15:32,960
OFTENTIMES WHAT THEY FIND MOST

4997
03:15:32,960 --> 03:15:36,840
INFORMATIVE ARE SECONDARY OR

4998
03:15:36,840 --> 03:15:38,480
SUBGROUP ANALYSES THAT REALLY

4999
03:15:38,480 --> 03:15:40,160
HAVE BIG INFLUENCE AND ARE NOT

5000
03:15:40,160 --> 03:15:42,640
JUST THE PRIMARY OUTCOMES.

5001
03:15:42,640 --> 03:15:43,960
AND SO I THINK THAT THAT'S

5002
03:15:43,960 --> 03:15:44,640
SOMETHING THAT'S REALLY

5003
03:15:44,640 --> 03:15:48,960
IMPORTANT FOR US TO THINK ABOUT

5004
03:15:48,960 --> 03:15:52,160
AS FUNDERS OF, YOU KNOW, ARE

5005
03:15:52,160 --> 03:15:53,800
THOSE ADDITIONAL QUESTIONS

5006
03:15:53,800 --> 03:15:56,120
INCLUDED IN THE AIMS AND, YOU

5007
03:15:56,120 --> 03:15:58,040
KNOW, IS THERE A REALLY GOOD

5008
03:15:58,040 --> 03:16:00,120
PARTNERSHIP BETWEEN THOSE HEALTH

5009
03:16:00,120 --> 03:16:01,800
CARE SYSTEMS AND INVESTIGATORS

5010
03:16:01,800 --> 03:16:03,200
SUCH THAT THEY HAVE REALLY

5011
03:16:03,200 --> 03:16:05,480
WEIGHED IN AND GIVEN INPUT ON

5012
03:16:05,480 --> 03:16:06,560
WHAT THOSE ADDITIONAL AIMS MAY

5013
03:16:06,560 --> 03:16:09,560
NEED TO BE AND WHAT ELSE SHOULD

5014
03:16:09,560 --> 03:16:13,600
BE COLLECTED BESIDES PRIMARY

5015
03:16:13,600 --> 03:16:13,880
OUTCOMES.

5016
03:16:13,880 --> 03:16:16,880
YOU KNOW, AS WE WERE TALKING,

5017
03:16:16,880 --> 03:16:18,040
HEARING FROM INVESTIGATORS HOW

5018
03:16:18,040 --> 03:16:19,240
HOPEFUL WORK GROUPS HAVE BEEN AS

5019
03:16:19,240 --> 03:16:22,160
PART OF THE STRUCTURE OF THIS

5020
03:16:22,160 --> 03:16:24,400
PROGRAM, IT ALWAYS MAKES ME

5021
03:16:24,400 --> 03:16:25,360
THINK ABOUT WHAT ABOUT RESEARCH

5022
03:16:25,360 --> 03:16:27,200
THAT CAN'T BE PART OF THE

5023
03:16:27,200 --> 03:16:27,440
PROGRAM?

5024
03:16:27,440 --> 03:16:28,360
YOU KNOW, WE CAN'T SUPPORT ALL

5025
03:16:28,360 --> 03:16:30,720
OF THESE TRIALS THAT ARE BEING

5026
03:16:30,720 --> 03:16:33,120
DONE, AND WE'RE SEEING MORE AND

5027
03:16:33,120 --> 03:16:34,520
MORE PRAGMATIC RESEARCH AND

5028
03:16:34,520 --> 03:16:36,120
CERTAINLY LOSS OF IMPLEMENTATION

5029
03:16:36,120 --> 03:16:38,920
SCIENCE HAPPENING OVER THE LAST

5030
03:16:38,920 --> 03:16:39,160
DECADE.

5031
03:16:39,160 --> 03:16:40,560
AND, YOU KNOW, I THINK WHAT

5032
03:16:40,560 --> 03:16:42,080
WE'VE TRIED TO DO WITH THIS

5033
03:16:42,080 --> 03:16:45,000
PROGRAM IS TO SHARE WHAT WE'VE

5034
03:16:45,000 --> 03:16:46,640
LEARNED BOTH THROUGH WORKSHOPS,

5035
03:16:46,640 --> 03:16:49,600
ALSO ON THE WEBSITE AND ON THE

5036
03:16:49,600 --> 03:16:58,120
TEXT BOOK ON THE BOOK,

5037
03:16:58,120 --> 03:16:58,680
clinicaltrials.gov, EVERYONE

5038
03:16:58,680 --> 03:16:59,560
HAS ACCESS TO THE INFORMATION,

5039
03:16:59,560 --> 03:17:01,520
WHERE WE PROVIDE TRAINING AND

5040
03:17:01,520 --> 03:17:02,720
OTHER THINGS TO REACH THE

5041
03:17:02,720 --> 03:17:03,640
BROADER COMMUNITY SO THAT YOU

5042
03:17:03,640 --> 03:17:05,280
DON'T HAVE TO FIGURE THIS OUT ON

5043
03:17:05,280 --> 03:17:09,640
YOUR OWN BUT YOU CAN ACTUALLY

5044
03:17:09,640 --> 03:17:12,040
FIND SOME OF WHAT'S LEARNED AND

5045
03:17:12,040 --> 03:17:14,440
HELP AROUND THINGS WE'RE

5046
03:17:14,440 --> 03:17:15,640
LEARNING LIKE BIOSTATISTICS AND

5047
03:17:15,640 --> 03:17:17,440
CLUSTER DESIGNS, A LOT OF

5048
03:17:17,440 --> 03:17:18,320
INTERESTING CONVERSATIONS WE'VE

5049
03:17:18,320 --> 03:17:19,400
HAD TODAY.

5050
03:17:19,400 --> 03:17:21,480
ONE THING THAT COMES TO MIND FOR

5051
03:17:21,480 --> 03:17:23,320
ME, WE DIDN'T SHARE A LOT OF

5052
03:17:23,320 --> 03:17:25,240
THOSE RESOURCES DIRECTLY AS PART

5053
03:17:25,240 --> 03:17:26,840
OF THIS WORKSHOP BUT I THINK

5054
03:17:26,840 --> 03:17:28,480
THERE'S A LOT OF INFORMATION

5055
03:17:28,480 --> 03:17:30,360
THAT PEOPLE WOULD FIND REALLY

5056
03:17:30,360 --> 03:17:31,840
RELEVANT IN HELPING DESIGN AND

5057
03:17:31,840 --> 03:17:36,400
CONDUCT THESE TYPES OF STUDIES,

5058
03:17:36,400 --> 03:17:38,720
ON THE WEBSITE.

5059
03:17:38,720 --> 03:17:41,960
KEVIN OR RICH, ADDITIONAL

5060
03:17:41,960 --> 03:17:44,280
THOUGHTS THAT YOU HAVE?

5061
03:17:44,280 --> 03:17:47,000
>>YEAH, I THINK IT WAS A
GREAT

5062
03:17:47,000 --> 03:17:47,560
WORKSHOP.

5063
03:17:47,560 --> 03:17:50,840
I KNOW I LEARNED A LOT.

5064
03:17:50,840 --> 03:17:52,400
IT DID SHOWCASE THE WAYS IN

5065
03:17:52,400 --> 03:17:55,520
WHICH, YOU KNOW, BRINGING

5066
03:17:55,520 --> 03:17:58,640
TOGETHER A COMMUNITY WITH SOME

5067
03:17:58,640 --> 03:18:00,360
SHARED COMMITMENT TO

5068
03:18:00,360 --> 03:18:02,280
TRANSPARENCY AND MUTUAL LEARNING

5069
03:18:02,280 --> 03:18:04,000
REALLY HAS BEEN BENEFICIAL AND

5070
03:18:04,000 --> 03:18:08,480
SO WHEN WE THINK ABOUT TRYING TO

5071
03:18:08,480 --> 03:18:10,120
LEARN FASTER, IT SEEMS LIKE

5072
03:18:10,120 --> 03:18:12,240
THERE ARE SOME LESSONS TO BE

5073
03:18:12,240 --> 03:18:13,960
LEARNED FROM LOOKING AT THAT,

5074
03:18:13,960 --> 03:18:18,360
THE WAY THAT CULTURE IS CREATED

5075
03:18:18,360 --> 03:18:19,120
AND MAINTAINED, IN A NETWORK

5076
03:18:19,120 --> 03:18:23,280
THAT CONTINUES TO GET NEW

5077
03:18:23,280 --> 03:18:23,560
ENTRANCE.

5078
03:18:23,560 --> 03:18:25,920
SO, THAT SEEMS TO BE AN

5079
03:18:25,920 --> 03:18:29,960
IMPORTANT MESSAGE AS YOU SAID.

5080
03:18:29,960 --> 03:18:31,600
I THINK ANOTHER THING THAT STOOD

5081
03:18:31,600 --> 03:18:37,920
OUT TO ME TOO WAS THE WAYS IN

5082
03:18:37,920 --> 03:18:39,480
WHICH PRAGMATIC TRIALS PRESENT

5083
03:18:39,480 --> 03:18:41,120
YOUR NICE CHALLENGES AND

5084
03:18:41,120 --> 03:18:43,400
OPPORTUNITIES IN TRYING TO --

5085
03:18:43,400 --> 03:18:44,920
UNIQUE CHALLENGES AND

5086
03:18:44,920 --> 03:18:46,120
OPPORTUNITIES LOOKING FOR EARLY

5087
03:18:46,120 --> 03:18:49,760
SIGNS SOMETHING MIGHT BE AMISS.

5088
03:18:49,760 --> 03:18:52,760
AND RESPOND TO THOSE.

5089
03:18:52,760 --> 03:18:54,920
AND THERE ARE BOTH CHALLENGES

5090
03:18:54,920 --> 03:18:57,840
AND OPPORTUNITIES DISTINCT FROM

5091
03:18:57,840 --> 03:18:58,600
TRADITIONAL TRIALS.

5092
03:18:58,600 --> 03:19:00,480
SO THAT SORT OF IS A THEME FOR

5093
03:19:00,480 --> 03:19:03,120
JUST ABOUT ANY TOPIC WE TALK

5094
03:19:03,120 --> 03:19:06,520
ABOUT IN THE COLLABORATORY, BUT

5095
03:19:06,520 --> 03:19:09,600
IT WAS INTERESTING TO SEE IT

5096
03:19:09,600 --> 03:19:13,080
MANIFESTED HERE AS WELL.

5097
03:19:13,080 --> 03:19:18,760
AND HOW THE DECISION MAKING

5098
03:19:18,760 --> 03:19:19,880
AROUND THAT BORDER, THAT

5099
03:19:19,880 --> 03:19:23,360
CONTINUUM, I FORGET WHO SAID IT

5100
03:19:23,360 --> 03:19:33,880
WAS A CONTINUUM, WE HAVE A NEW

5101
03:19:35,360 --> 03:19:38,680
INTERVENTION WE'RE TESTING CAN'T

5102
03:19:38,680 --> 03:19:39,880
BE RESOLVED BUT INTERESTING TO

5103
03:19:39,880 --> 03:19:41,240
TRACK THAT IN THE FUTURE TOO.

5104
03:19:41,240 --> 03:19:46,680
A LOT OF OTHER STUFF BUT I'LL

5105
03:19:46,680 --> 03:19:47,160
STOP THERE.

5106
03:19:47,160 --> 03:19:50,320
>> FOR ME THE MOST
IMPORTANT

5107
03:19:50,320 --> 03:19:52,800
TAKEAWAY OF THE MEETING WE'VE

5108
03:19:52,800 --> 03:19:54,480
HAD AND THE SEVERAL PLANNING

5109
03:19:54,480 --> 03:19:56,960
MEETINGS THAT WENT INTO THIS IS

5110
03:19:56,960 --> 03:20:02,240
THE IMPORTANCE OF CONTINGENCY

5111
03:20:02,240 --> 03:20:04,200
PLANNING, BEING EXPLICIT ABOUT

5112
03:20:04,200 --> 03:20:06,520
ARTICULATING, AS MANY OF THE

5113
03:20:06,520 --> 03:20:11,120
SORT OF POSSIBLE SITUATIONS THAT

5114
03:20:11,120 --> 03:20:12,960
MIGHT ARISE, AND BEING CLEAR, AS

5115
03:20:12,960 --> 03:20:15,400
CLEAR AS POSSIBLE, ABOUT HOW ONE

5116
03:20:15,400 --> 03:20:17,680
WOULD DEAL WITH THAT.

5117
03:20:17,680 --> 03:20:19,720
THE MORE YOU CAN AVOID OPERATING

5118
03:20:19,720 --> 03:20:24,320
IN THE COMPLETELY GRAY SPACE,

5119
03:20:24,320 --> 03:20:27,400
WHERE WE DEPEND ON PEOPLE WHO

5120
03:20:27,400 --> 03:20:31,920
ARE AS THOUGHTFUL AS TISHA TO

5121
03:20:31,920 --> 03:20:32,960
DECIDE WHETHER SOMETHING IS IN

5122
03:20:32,960 --> 03:20:41,200
SCOPE OR NOT WILL SERVE US WELL.

5123
03:20:41,200 --> 03:20:44,040
NOT THAT INVESTIGATORS HAVEN'T

5124
03:20:44,040 --> 03:20:46,000
BEEN ATTENTIVE TO THAT BUT

5125
03:20:46,000 --> 03:20:48,640
THERE'S ROOM TO DO MORE, TO PUT

5126
03:20:48,640 --> 03:20:51,600
MORE TIME AND ENERGY INTO THAT

5127
03:20:51,600 --> 03:20:54,480
KIND OF PREPARATION I THINK

5128
03:20:54,480 --> 03:20:59,040
WOULD SERVE US WELL. 

5129
03:20:59,040 --> 03:21:00,920
>> GREG HAS A HAND UP.

5130
03:21:00,920 --> 03:21:04,840
>> SURE DOES.

5131
03:21:04,840 --> 03:21:05,040
GREG?

5132
03:21:05,040 --> 03:21:06,280
>> YEAH, THANKS.

5133
03:21:06,280 --> 03:21:11,080
I WANT TO SAY, RICH, YOU  HAD

5134
03:21:11,080 --> 03:21:13,480
BROUGHT THIS UP, THE LANGUAGE IN

5135
03:21:13,480 --> 03:21:15,800
PLANNING MEETINGS, THE IDEA OF

5136
03:21:15,800 --> 03:21:17,560
FAILING FASTER, SAID NO, IT

5137
03:21:17,560 --> 03:21:18,840
SHOULD BE LEARNING FASTER.

5138
03:21:18,840 --> 03:21:21,440
BUT ONE OF THE THINGS WE TOOK AT

5139
03:21:21,440 --> 03:21:23,320
THE PLANNING MEETINGS, IT'S

5140
03:21:23,320 --> 03:21:24,680
IMPORTANT TO EMPHASIZE, IS THAT,

5141
03:21:24,680 --> 03:21:26,720
YOU KNOW, IF THE GOAL IS TO

5142
03:21:26,720 --> 03:21:30,320
BUILD A PLATFORM TO ANSWER

5143
03:21:30,320 --> 03:21:31,880
QUESTIONS, YOU KNOW, IT'S NOT

5144
03:21:31,880 --> 03:21:34,920
THE IDEA OF THIS THING WE'RE

5145
03:21:34,920 --> 03:21:36,560
TRYING DOES NOT WORK.

5146
03:21:36,560 --> 03:21:39,560
WE FIGURED THAT OUT QUICKLY,

5147
03:21:39,560 --> 03:21:41,960
WHAT'S NEXT, IT'S THE WHAT'S

5148
03:21:41,960 --> 03:21:45,080
NEXT THAT'S OFTEN MISSING.

5149
03:21:45,080 --> 03:21:46,520
AND, YOU KNOW, ESPECIALLY IF

5150
03:21:46,520 --> 03:21:50,920
WE'RE TALKING ABOUT THIS PHASED

5151
03:21:50,920 --> 03:21:52,240
AWARD PROCESS, TWO-STAGE THING,

5152
03:21:52,240 --> 03:21:54,840
THEY ARE DIFFERENT LETTERS AND

5153
03:21:54,840 --> 03:21:58,120
NUMBERS USED, BUT SAY UH2/UH3

5154
03:21:58,120 --> 03:22:00,240
MODEL, WE NEED TO HAVE THE

5155
03:22:00,240 --> 03:22:09,000
ABILITY TO HAVE A UT 2A, UH2C,

5156
03:22:09,000 --> 03:22:10,200
UH3C MODEL, WHEN APPROPRIATE,

5157
03:22:10,200 --> 03:22:13,280
BECAUSE IF THE ONLY OPTION IS,

5158
03:22:13,280 --> 03:22:14,680
YOU KNOW, AFTER SAYING THE FIRST

5159
03:22:14,680 --> 03:22:17,400
THING WE TRIED DIDN'T WORK,

5160
03:22:17,400 --> 03:22:20,720
LET'S SHUT DOWN, IT CREATES BAD

5161
03:22:20,720 --> 03:22:21,680
INCENTIVES TO TRY TO MAKE

5162
03:22:21,680 --> 03:22:23,000
SOMETHING LOOK LIKE IT'S WORKING

5163
03:22:23,000 --> 03:22:27,160
WHEN IT DOESN'T BUT ALSO IS

5164
03:22:27,160 --> 03:22:27,600
WASTEFUL.

5165
03:22:27,600 --> 03:22:28,760
THIS IS COMPLICATED THOUGH, IN

5166
03:22:28,760 --> 03:22:32,440
TERMS OF ASKING THE QUESTION

5167
03:22:32,440 --> 03:22:38,840
ABOUT WHEN IN TERMS OF SORT OF

5168
03:22:38,840 --> 03:22:41,760
STRATEGICALLY WHEN FUNDERS, NIH

5169
03:22:41,760 --> 03:22:45,400
OR PCORI, THINKING ABOUT THE BIG

5170
03:22:45,400 --> 03:22:46,280
PICTURE SEPARATELY CONSIDERING

5171
03:22:46,280 --> 03:22:48,120
THE ISSUES IS THIS THE RIGHT

5172
03:22:48,120 --> 03:22:49,360
QUESTION, FRAMED THE RIGHT WAY?

5173
03:22:49,360 --> 03:22:51,520
IS THIS THE RIGHT SETTING OR ARE

5174
03:22:51,520 --> 03:22:53,920
THESE THE RIGHT SETTINGS TO

5175
03:22:53,920 --> 03:22:55,000
ANSWER THE QUESTION?

5176
03:22:55,000 --> 03:22:56,760
YOU KNOW, ARE THESE THE RIGHT

5177
03:22:56,760 --> 03:22:58,960
PEOPLE, ARE THESE PEOPLE

5178
03:22:58,960 --> 03:22:59,400
QUALIFIED?

5179
03:22:59,400 --> 03:23:01,800
AND IS THIS THE BEST SOLUTION OR

5180
03:23:01,800 --> 03:23:04,280
BEST THING TO DO BASED ON WHAT

5181
03:23:04,280 --> 03:23:06,400
WE KNOW RIGHT NOW, AND THEN THE

5182
03:23:06,400 --> 03:23:08,160
THING WE DON'T CONSIDER IS WHAT

5183
03:23:08,160 --> 03:23:09,560
WOULD BE THE BACKUP PLAN?

5184
03:23:09,560 --> 03:23:15,720
YOU KNOW, IS THERE A BACKUP PLAN

5185
03:23:15,720 --> 03:23:17,360
IF THIS DOESN'T WORKS THERE

5186
03:23:17,360 --> 03:23:19,200
SOMETHING ELSE WE MIGHT TEST?

5187
03:23:19,200 --> 03:23:19,960
IT'S COMPLICATED.

5188
03:23:19,960 --> 03:23:22,600
CERTAINLY THIS COULD NEVER

5189
03:23:22,600 --> 03:23:24,640
HAPPEN WITH R MECHANISMS GRANTS.

5190
03:23:24,640 --> 03:23:27,800
THE U MECHANISM THAT'S BEEN USED

5191
03:23:27,800 --> 03:23:28,440
FOR THESE COLLABORATIVE TRIALS

5192
03:23:28,440 --> 03:23:33,240
IS A STEP IN THE RIGHT DIRECTION

5193
03:23:33,240 --> 03:23:35,480
BUT MAYBE WE NEED TO MOVE

5194
03:23:35,480 --> 03:23:37,680
FURTHER IN TERMS OF

5195
03:23:37,680 --> 03:23:46,320
COLLABORATIVE PLANNING FOR THE

5196
03:23:46,320 --> 03:23:48,320
"WHAT IF."

5197
03:23:48,320 --> 03:23:48,840
>> GREAT.

5198
03:23:48,840 --> 03:23:51,040
WENDY, YOU SPEAK FOR THE ENTIRE

5199
03:23:51,040 --> 03:23:56,200
NIH SO CAN WE DO THAT?

5200
03:23:56,200 --> 03:24:00,120
>> I CERTAINLY DON'T
SPEAK FOR

5201
03:24:00,120 --> 03:24:03,720
THE WHOLE NIH, BUT I THINK, YOU

5202
03:24:03,720 --> 03:24:05,920
KNOW, COOPERATIVE AGREEMENTS, U

5203
03:24:05,920 --> 03:24:08,440
MECHANISMS, DEFINITELY GIVE US

5204
03:24:08,440 --> 03:24:10,640
MORE FLEXIBILITY, FOR SURE, THAN

5205
03:24:10,640 --> 03:24:13,880
R PROJECT GRANTS DO.

5206
03:24:13,880 --> 03:24:16,560
SO I THINK WE'RE ALSO STARTING

5207
03:24:16,560 --> 03:24:19,520
TO SEE AN APPLICATION MORE

5208
03:24:19,520 --> 03:24:21,280
COMMONLY CONTINGENCY PLANS AND

5209
03:24:21,280 --> 03:24:24,960
SORT OF WHAT IF SORT OF

5210
03:24:24,960 --> 03:24:29,800
SCENARIOS IF THINGS DON'T GO AS

5211
03:24:29,800 --> 03:24:30,040
PLANNED.

5212
03:24:30,040 --> 03:24:33,280
AND SOMETHING THAT WE KIND OF

5213
03:24:33,280 --> 03:24:38,640
TALKED ABOUT WAS MONITORING FOR

5214
03:24:38,640 --> 03:24:40,840
EITHER FIDELITY OR UPTAKE OF

5215
03:24:40,840 --> 03:24:43,880
INTERVENTION, MONITORING

5216
03:24:43,880 --> 03:24:45,280
ELEMENTS OF STUDIES ONGOING AND

5217
03:24:45,280 --> 03:24:47,080
THEN, YOU KNOW, WHAT I OFTEN ASK

5218
03:24:47,080 --> 03:24:48,920
WHEN WE SEE THESE APPLICATIONS

5219
03:24:48,920 --> 03:24:52,120
COME IN TO US HERE AT NCCIH, I'M

5220
03:24:52,120 --> 03:24:53,520
GOING TO MONITOR BUT WHAT

5221
03:24:53,520 --> 03:24:55,680
HAPPENS IF YOU SEE THIS OR IF

5222
03:24:55,680 --> 03:24:57,400
YOU SEE THAT, ARE YOU GOING TO

5223
03:24:57,400 --> 03:24:59,000
DO ANYTHING ABOUT IT?

5224
03:24:59,000 --> 03:25:01,400
AND CAN YOU DO ANYTHING ABOUT

5225
03:25:01,400 --> 03:25:01,560
IT?

5226
03:25:01,560 --> 03:25:04,200
WE'VE SEEN EXAMPLES ACROSS THE

5227
03:25:04,200 --> 03:25:05,400
COLLABORATORY WHERE THAT

5228
03:25:05,400 --> 03:25:07,600
TRIGGERS AN ACTION WHICH IS

5229
03:25:07,600 --> 03:25:10,440
REALLY CLEAR AND PRE-PLANNED AND

5230
03:25:10,440 --> 03:25:12,040
EASILY UNDERTAKEN AND IN OTHER

5231
03:25:12,040 --> 03:25:16,160
CASES WHERE IT'S NOT GOING AS

5232
03:25:16,160 --> 03:25:17,080
PLANNED, AND YES, SOMETHING

5233
03:25:17,080 --> 03:25:21,120
COULD BE DONE BUT THE COST TO DO

5234
03:25:21,120 --> 03:25:24,400
SOMETHING IS JUST BEYOND THE

5235
03:25:24,400 --> 03:25:26,480
SCOPE OF THE AWARD, AND SO IT

5236
03:25:26,480 --> 03:25:28,480
ACTUALLY CAN'T ACT TO MAKE

5237
03:25:28,480 --> 03:25:31,400
CHANGE IN TERMS OF UPTAKE OR

5238
03:25:31,400 --> 03:25:33,800
ADHERENCE OR THESE TYPES OF

5239
03:25:33,800 --> 03:25:34,280
THINGS.

5240
03:25:34,280 --> 03:25:34,920
BEING REALISTIC IN WALKING

5241
03:25:34,920 --> 03:25:37,640
THROUGH SOME OF THE THOSE

5242
03:25:37,640 --> 03:25:40,200
DISCUSSIONS UP FRONT I THINK

5243
03:25:40,200 --> 03:25:42,240
WITH YOUR PROGRAM OFFICERS AND

5244
03:25:42,240 --> 03:25:44,240
IN THE PLANNING PHASES AND THEN

5245
03:25:44,240 --> 03:25:48,160
IN WHAT YOUR PROTOCOL LOOKS

5246
03:25:48,160 --> 03:25:50,880
LIKE, AND WHAT YOUR CONTINGENCY

5247
03:25:50,880 --> 03:25:52,440
PLANS WILL BE, PLANNING FOR

5248
03:25:52,440 --> 03:25:53,920
THINGS YOU CAN ANTICIPATE WOULD

5249
03:25:53,920 --> 03:25:54,560
BE REALLY HELPFUL.

5250
03:25:54,560 --> 03:25:57,320
>> I WAS GOING TO ADD IF
WE

5251
03:25:57,320 --> 03:25:58,880
LOOK AT THE HISTORY, NOW THERE'S

5252
03:25:58,880 --> 03:26:00,440
A HISTORY ABOUT THESE

5253
03:26:00,440 --> 03:26:00,960
DEMONSTRATION PROJECTS AND

5254
03:26:00,960 --> 03:26:01,960
COLLABORATORY, I THINK WE CAN

5255
03:26:01,960 --> 03:26:03,800
POINT TO A COUPLE OF EXAMPLES

5256
03:26:03,800 --> 03:26:05,160
THAT DIDN'T DO EXACTLY THAT

5257
03:26:05,160 --> 03:26:08,200
THING I WAS TALKING ABOUT BUT

5258
03:26:08,200 --> 03:26:10,080
WE'RE KIND OF GETTING THERE.

5259
03:26:10,080 --> 03:26:11,120
FOR INSTANCE, DIALYSIS.

5260
03:26:11,120 --> 03:26:13,000
THERE'S A LOT OF QUESTIONS ABOUT

5261
03:26:13,000 --> 03:26:16,200
WHAT TO DO IN DIALYSIS.

5262
03:26:16,200 --> 03:26:17,920
THE ORIGINAL TIME TRIAL, WHICH

5263
03:26:17,920 --> 03:26:19,680
WAS ABOUT DURATION OF DIALYSIS,

5264
03:26:19,680 --> 03:26:25,480
IT WAS  ONE THAT DID LEARN FAST,

5265
03:26:25,480 --> 03:26:27,360
THIS ISN'T GOING TO WORK.

5266
03:26:27,360 --> 03:26:30,520
THEN WENT TO THE HIGH/LOW STUDY,

5267
03:26:30,520 --> 03:26:35,920
WHICH WAS A DIFFERENT BUT VERY

5268
03:26:35,920 --> 03:26:38,000
IMPORTANT QUESTION ABOUT DEFAULT

5269
03:26:38,000 --> 03:26:39,320
SETTINGS OF DIALYSIS, WHAT

5270
03:26:39,320 --> 03:26:42,040
SHOULD BE OUR DEFAULT WAY OF

5271
03:26:42,040 --> 03:26:42,800
APPROACHING HEMODIALYSIS?

5272
03:26:42,800 --> 03:26:45,560
IT EVEN HAD TO DO A PIVOT.

5273
03:26:45,560 --> 03:26:48,920
NOW, THERE WAS A LONG GAP

5274
03:26:48,920 --> 03:26:52,760
BETWEEN TIME AND HIGH/LOW, YOU

5275
03:26:52,760 --> 03:26:54,160
KNOW, IN THIS IMAGINARY WORLD, I

5276
03:26:54,160 --> 03:26:57,280
THINK WE WOULD SAY WHAT ARE THE

5277
03:26:57,280 --> 03:26:59,000
QUESTIONS ABOUT DIALYSIS, LET'S

5278
03:26:59,000 --> 03:27:00,640
SET UP THE PLATFORM TO USE THE

5279
03:27:00,640 --> 03:27:02,920
TERM THAT SOME PEOPLE USE, TO

5280
03:27:02,920 --> 03:27:04,400
STUDY QUESTIONS ABOUT DIALYSIS

5281
03:27:04,400 --> 03:27:06,320
AND LET'S SAY WHAT'S THE HIGHEST

5282
03:27:06,320 --> 03:27:07,880
PRIORITY QUESTION FOR RIGHT NOW,

5283
03:27:07,880 --> 03:27:09,600
WHAT'S THE THING WE WANT TO DO,

5284
03:27:09,600 --> 03:27:11,720
BUT BE READY TO PIVOT QUICKLY.

5285
03:27:11,720 --> 03:27:12,680
THAT DID HAPPEN.

5286
03:27:12,680 --> 03:27:17,960
BUT IT TOOK A WHILE. 

5287
03:27:17,960 --> 03:27:22,560
YOU KNOW, IN TERMS OF ISSUES

5288
03:27:22,560 --> 03:27:23,840
ABOUT HOSPITAL-ACQUIRED

5289
03:27:23,840 --> 03:27:24,720
INFECTION, INFECTION CONTROL IN

5290
03:27:24,720 --> 03:27:26,680
HOSPITALS, I THINK IT'S FAIR TO

5291
03:27:26,680 --> 03:27:30,840
SAY MAYBE THAT HCA IS THE TRIAL

5292
03:27:30,840 --> 03:27:32,280
PLATFORM.

5293
03:27:32,280 --> 03:27:35,240
HERE WE ARE AT ROUND 2.

5294
03:27:35,240 --> 03:27:36,880
THERE WAS A DAY IN SAYING WHAT'S

5295
03:27:36,880 --> 03:27:37,400
THE NEXT QUESTION.

5296
03:27:37,400 --> 03:27:39,920
I THINK IN A PERFECT WORLD WE

5297
03:27:39,920 --> 03:27:40,840
MIGHT BE ALREADY PLANNING FOR,

5298
03:27:40,840 --> 03:27:45,880
OKAY, IF THIS IS GOING TO BE OUR

5299
03:27:45,880 --> 03:27:47,840
PLATFORM, NOW, YOU MIGHT NEED TO

5300
03:27:47,840 --> 03:27:50,680
MAKE ALLOWANCES FOR THE PLATFORM

5301
03:27:50,680 --> 03:27:52,120
EXPANDING OR SHIFTING OVER TIME

5302
03:27:52,120 --> 03:27:55,400
AS THE WORLD CHANGES, BUT THE

5303
03:27:55,400 --> 03:27:57,760
POTENTIAL SPEED, IF WE WANT TO

5304
03:27:57,760 --> 03:28:01,320
GO FASTER IT'S THE REUSABILITY

5305
03:28:01,320 --> 03:28:02,280
OF THE INFRASTRUCTURE I THINK

5306
03:28:02,280 --> 03:28:05,480
THAT'S A REALLY KEY THING.

5307
03:28:05,480 --> 03:28:08,000
>> YEAH, YEAH.

5308
03:28:08,000 --> 03:28:10,920
CERTAINLY THERE ARE EXAMPLES AND

5309
03:28:10,920 --> 03:28:12,520
YOU'RE WELL AWARE, GREG,

5310
03:28:12,520 --> 03:28:13,440
EXAMPLES WHERE INSTITUTES HAVE

5311
03:28:13,440 --> 03:28:18,560
SET UP EITHER A TRIAL NETWORK OR

5312
03:28:18,560 --> 03:28:22,640
A PLATFORM TYPE OF STRUCK TUSH

5313
03:28:22,640 --> 03:28:23,200
 STRUCTURE TO

5314
03:28:23,200 --> 03:28:24,480
DO A SERIES OF TRIALS AND

5315
03:28:24,480 --> 03:28:25,840
UTILIZE THE SAME INFRASTRUCTURE.

5316
03:28:25,840 --> 03:28:28,680
WHAT WE STRUGGLED WITH IN

5317
03:28:28,680 --> 03:28:30,320
PRAGMATIC TRIAL SPACE IS HOW WE

5318
03:28:30,320 --> 03:28:31,440
SET THESE PROJECTS UP, EVERYBODY

5319
03:28:31,440 --> 03:28:34,360
COMES IN WITH THEIR OWN PARTNERS

5320
03:28:34,360 --> 03:28:36,040
FOR EACH INDIVIDUAL APPLICATION,

5321
03:28:36,040 --> 03:28:37,960
AS OPPOSED TO HAVING SORT OF A

5322
03:28:37,960 --> 03:28:41,680
NETWORK THAT HAS BEEN SET UP, I

5323
03:28:41,680 --> 03:28:43,760
THINK OTHER FUNDING GROUPS,

5324
03:28:43,760 --> 03:28:45,120
PCORnet, PCORI IS A GREAT

5325
03:28:45,120 --> 03:28:47,520
EXAMPLE TO TRIED TO SET UP A

5326
03:28:47,520 --> 03:28:49,000
NETWORK EXAMPLE THAT CAN DO THAT

5327
03:28:49,000 --> 03:28:50,440
IN HEALTH CARE SYSTEMS THAT WAY.

5328
03:28:50,440 --> 03:28:52,640
I DON'T KNOW, RICH, IF YOU WANT

5329
03:28:52,640 --> 03:28:55,800
TO COMMENT ON THAT AS A

5330
03:28:55,800 --> 03:29:00,080
DIFFERENT EXAMPLE, OF OF ANOTHER

5331
03:29:00,080 --> 03:29:01,960
WAVE TRYING TO DO MORE TRIALS

5332
03:29:01,960 --> 03:29:03,600
QUICKLY IT'S NOT ALWAYS EASY TO

5333
03:29:03,600 --> 03:29:06,520
DO IT THAT WAY, DEPENDING HOW

5334
03:29:06,520 --> 03:29:09,480
BROAD THE SCOPE OF THE TRIALS

5335
03:29:09,480 --> 03:29:10,680
COULD BE.

5336
03:29:10,680 --> 03:29:12,880
I THINK THE ONES MOST SUCCESSFUL

5337
03:29:12,880 --> 03:29:18,800
ARE COLLEAGUES AT NIDA AND THEIR

5338
03:29:18,800 --> 03:29:20,120
CLINICAL TRIAL NETWORK AROUND

5339
03:29:20,120 --> 03:29:20,960
OVERDOSE AND SUBSTANCE USE, THEY

5340
03:29:20,960 --> 03:29:22,760
ARE ABLE TO DO SORT OF NEXT

5341
03:29:22,760 --> 03:29:25,040
TRIAL AND THE NEXT TRIAL WITHIN

5342
03:29:25,040 --> 03:29:25,800
THE INFRASTRUCTURE THEY HAVE,

5343
03:29:25,800 --> 03:29:34,640
IT'S A LITTLE BIT EASIER,

5344
03:29:34,640 --> 03:29:36,280
PEDIATRIC ONCOLOGY, CHILDREN'S

5345
03:29:36,280 --> 03:29:37,640
ONCOLOGY GROUP, THEY PRIORITIZE

5346
03:29:37,640 --> 03:29:40,360
AND MOVE INTO THE NEXT STUDY.

5347
03:29:40,360 --> 03:29:42,240
AS YOU GET LESS SPECIFIC AND WHO

5348
03:29:42,240 --> 03:29:46,440
THE FUNDER IS THE GETS MORE

5349
03:29:46,440 --> 03:29:46,720
CHALLENGING.

5350
03:29:46,720 --> 03:29:50,560
>> AGREED.

5351
03:29:50,560 --> 03:29:55,000
>> I HAVE A COUPLE
LAST-MINUTE

5352
03:29:55,000 --> 03:29:56,760
CLOSING COMMENTS TO THANK

5353
03:29:56,760 --> 03:29:57,040
EVERYBODY.

5354
03:29:57,040 --> 03:29:58,840
RICH OR KEVIN, ANYTHING YOU WANT

5355
03:29:58,840 --> 03:30:03,680
TO ADD BEFORE WE WRAP UP FOR THE

5356
03:30:03,680 --> 03:30:03,960
AFTERNOON?

5357
03:30:03,960 --> 03:30:05,960
>> NO, SEND US HOME.

5358
03:30:05,960 --> 03:30:08,240
>> JUST OUR GRATITUDE TO
ALL

5359
03:30:08,240 --> 03:30:10,000
THE PEOPLE THAT PARTICIPATED AND

5360
03:30:10,000 --> 03:30:13,800
EVERYBODY WHO HUNG IN THERE AND

5361
03:30:13,800 --> 03:30:14,040
ATTENDED.

5362
03:30:14,040 --> 03:30:17,960
>> YES, YES.

5363
03:30:17,960 --> 03:30:27,640
YEAH, THANK YOU TO THE

5364
03:30:27,640 --> 03:30:27,920
ATTENDEES.

5365
03:30:27,920 --> 03:30:32,560
WE'LL  FOLLOW UP WITH ANSWERS TO

5366
03:30:32,560 --> 03:30:36,280
THE SPECIFIC QUESTIONS BUT WE

5367
03:30:36,280 --> 03:30:37,040
GOT TO MANY.

5368
03:30:37,040 --> 03:30:40,880
I WANT TO THANK AGAIN ALL OF OUR

5369
03:30:40,880 --> 03:30:43,720
SPEAKERS, ALL OF OUR HEALTH CARE

5370
03:30:43,720 --> 03:30:44,600
SYSTEM PARTNERS, OUR

5371
03:30:44,600 --> 03:30:46,800
INVESTIGATORS, MY COLLEAGUES

5372
03:30:46,800 --> 03:30:49,000
ACROSS NIH WHO BRAVELY CAME ON

5373
03:30:49,000 --> 03:30:50,400
AND TALKED ABOUT CHALLENGING

5374
03:30:50,400 --> 03:30:59,920
SCENARIOS AND HOW THEY HANDLE

5375
03:30:59,920 --> 03:31:01,960
THEM.

5376
03:31:01,960 --> 03:31:06,480
 THE PLANNING COMMITTEE, RICH

5377
03:31:06,480 --> 03:31:08,560
AND KEVIN, THE KEYNOTE SPEAKER

5378
03:31:08,560 --> 03:31:09,200
YESTERDAY, BUT THOSE PEOPLE

5379
03:31:09,200 --> 03:31:15,120
BEHIND THE SCENES THAT WE DON'T

5380
03:31:15,120 --> 03:31:16,440
ALWAYS SEE ON SCREEN, OUR

5381
03:31:16,440 --> 03:31:19,160
COLLEAGUES AT NIH WHO HELPED US

5382
03:31:19,160 --> 03:31:21,880
WITH VIDEOCAST, THANK YOU

5383
03:31:21,880 --> 03:31:24,000
TREMENDOUSLY FOR MAKING THIS

5384
03:31:24,000 --> 03:31:24,960
AVAILABLE, AND ARCHIVED, SO THAT

5385
03:31:24,960 --> 03:31:29,920
ANY OF YOU WHO MISSED THIS LIVE

5386
03:31:29,920 --> 03:31:36,920
CAN TUNE IN, ALSO THE

5387
03:31:36,920 --> 03:31:37,480
COLLABORATORY COORDINATING

5388
03:31:37,480 --> 03:31:39,520
CENTER TEAM, AND ALL THE OTHERS,

5389
03:31:39,520 --> 03:31:40,800
I KNOW HELPING WITH THIS AS

5390
03:31:40,800 --> 03:31:41,040
WELL.

5391
03:31:41,040 --> 03:31:43,600
THANK YOU SO MUCH FOR ALL OF

5392
03:31:43,600 --> 03:31:45,880
YOUR HELP AND MAKING THIS

5393
03:31:45,880 --> 03:31:46,280
HAPPEN.

5394
03:31:46,280 --> 03:31:48,600
I THINK THAT'S IT FOR US TODAY.

5395
03:31:48,600 --> 03:31:51,240
AND SO I THINK WE'LL GO AHEAD

5396
03:31:51,240 --> 03:31:52,840
AND CLOSE AND JUST THANKS FOR

5397
03:31:52,840 --> 03:31:54,160
JOINING US.

5398
03:31:54,160 --> 03:31:58,520
FEEL FREE TO FIND THIS ON THE

5399
03:31:58,520 --> 03:32:00,320
RETHINKINGCLINICAL TRIALS.ORG.

5400
03:32:00,320 --> 03:32:03,400
TUNE IN NEXT YEAR.

5401
03:32:03,400 --> 03:32:15,560
BYE-BYE.

5402
03:32:15,560 --> 03:32:19,160
 

5403
03:32:19,160 --> 03:32:25,280
 

5404
03:32:25,280 --> 03:32:35,320