I'm really excited to be talking with you
all today
about the bride issue of recruitment
and retention into clinical research,
and health research studies.
So I have no relative
or relevant financial relationships to
report
or conflicts of interest.
And just to get us started,
you all probably know this, but clinical trials are not just one
thing.
They are diverse and hype and topic.
So for example, there are behavioral studies.
There are genetic studies.
There are people who choose to participate
in surgery
studies or drug trials or vaccine trials
or trials that are focused
on social social support or like symptom management.
There are also different phases of clinical trials.
So phase one, face to face three.
I, I'm going to talk about this later,
but I have been a participant
in a phase one vaccine trial
and it the target populations can differ.
In some situations we are focusing on children.
In some situations we may have a focus
on older adults or families.
And in some situations we may actually be focusing,
exclusively or primarily on pregnant women.
So before
we actually get started,
just imagine that you have a neighbor.
Her name is Wanda, and she knows that you either
work at NIH
or very interested in clinical trials
and health research.
And she's trying to find a clinical trial
for people living with type two diabetes.
And if she came to your door, tonight
and asked her help, where would you start
if you wanted to help her find a clinical trial for type two
diabetes?
Of all of these places, where would you start?
And we'll talk a little bit about that
more later.
So the before we kind of get in-depth
into strategies and, ways of recruitment and
retention,
I want to just highlight a few example models.
So this model by Ford
and colleagues is actually one of the first clinical trial,
conceptual frameworks I became aware of,
when I was a doctoral student.
And broadly, they posit that,
barriers can be categorized
as awareness barriers or promoters,
opportunity barriers or promoters.
And then acceptance or refusal. So,
awareness opportunities and things that can,
potentially impact people's decision to
participate.
So this is one of the earlier earliest frameworks
that I have been aware of, although I'm sure there are
many.
So just keep that in the back of your mind.
And then, more recent.
Well, relatively more recently, the prior one was published
online in 2007 and then in print in 2008.
And in 2021, Wilkins and colleagues,
as part of their involvement with the Recruitment Innovation
Center.
Their recruitment Innovation center
is actually part of the Trial Innovation
Network, which is actually funded
by the National Center for Advancing
Translational Sciences, and that's part of NIH.
So they, put forth this conceptual model
of, participant recruitment efforts.
And most of these are pretty explanatory.
So there's awareness, how they conceptualize
feasibility is more
from the concept of making sure you have enough of an eligible
population.
So you may be accessing feasibility
through things like
electronic health records, making sure you have a big
enough pool
opportunity, very similar to the past models
like do people know that these opportunities are
available?
Then there's screening implications.
Invitation to participate.
So it's great to have clinical trials in the
world,
but you have to have ways to invite patients and
participants.
Then there's consent.
Hopefully if people are well consented
and think this through,
they will go on to enroll in the trial
and then there's engagement
and retention throughout the trial.
So it's really about communication
and making people feel like they have some sense of
connectedness.
And then they talk about return of value
and how they conceptualize return of value.
Is this idea of getting or giving back
individual results and also study results to
participants?
Even if they're if it's not clinically
meaningful,
but they talk about really this return of information,
as respecting or, uplifting the idea of respect
for persons.
And then finally, this is
actually my conceptual model, which ironically, I had,
published in a special supplement focused
on vaccines, clinical trials.
So this was in the Journal of Health
Communication.
And so this is actually, a general model
of clinical trial participation
that have been developing actually for many years
and finally got it published in this, during Covid.
I'm not going to go over every single bullet point,
but I just want, us to just appreciate
that a lot of things happened
between us as researchers creating a clinical trial.
Trial idea, and people actually enrolling
or getting to the end of a trial.
And in particular, I like to pay
a lot of attention to clinical trial
characteristics.
So the decisions that we make, often
as, study teams,
in terms of the intervention and how many procedures and
things
like number of study visits and incentives, all of those
clinical trial characteristics impacts
people's willingness or,
availability or,
really access to do the things we're asking them to do.
And then I also like to highlight, really
the communication throughout the trial
is very important to thinking about
how will you reach people.
Who's your audience, what's the context and the
messaging.
And then at the really effort and a lot of things that we
think
about as researchers are, you know, did people decline or
enroll?
How much retention did we have.
And, as someone who studies medical decision making,
I'm often interested in do people have decision regret?
So if you're in a trial and everything went well,
you probably okay if things didn't quite
go so well, you may have decision regret,
but if you
in principle had a very good informed
consent process, you will know that.
You know, things may not go perfectly
well,
but if you've had a good consent process,
those expectations should be managed.
As part of that same,
paper that I, had published of my general model
of clinical trial participation, I also put forth this ask
approach for enhancing clinical trial participation.
And as some of you know, more contemporary research
has been showing that particularly for minority
groups and underrepresented groups,
the narrative historically has been
people are afraid, they have mistrust, they have
distrust.
And all of that is true, that that is a component.
But a lot of research has shown that people are just often
literally not asked to participate
and not given the opportunities.
So it stands for just assume
that all patients want to know their options,
even if one of their options is a clinical trial.
And we can, have faith that they're able
to make a decision about their own
healthcare plan, potentially including the option of a trial.
We also want
to seek the counsel of stakeholders.
And at my next slide, we'll talk a little bit more
about that.
And then the K stands for Know Your numbers.
And I'm not talking about your blood
pressure numbers or your triglycerides
or things like that.
Although you should get your general checkups.
This is really about knowing
and not only your power calculations,
how many people
you'll need to be in a study, but also what is your
theoretical pool.
So if you work with a biostatistician
and they say you're going to need
300 people with lupus who are left handed
and live in Bethesda, Maryland, if you need 300 people,
but you've only seen 50 people per year
in the last three years, that's 150.
You're already going to have a problem
before you start, because you didn't
really think about what your theoretical
pool of people is going to be.
Now, clearly, just because you have enough
people doesn't mean
they're all going to say yes, but at least have to have a big
enough
theoretical pool to, recruit whatever
sample size you believe is sufficient.
So stakeholders
may include, but are not limited to all of these bullet points.
Each time I give this talk, someone comes up with another
stakeholder group that I should think of. But,
in the last round, one of the last talks
I gave, when of my community
partners said, you know, you should
include community health workers.
So, depending on your research study,
you may not need to include all of these people.
But I was involved with a lot of consultations,
particularly, for some of the Covid clinical
trials.
And in addition to patients and researchers,
we worked a lot with our communications
and marketing folks
because we did a lot of public advertisement.
If you are going to be querying your electronic health
record, you may need to, connect to work with your health.
IT people.
Almost everyone here is going to interact with
their IRB.
But, some,
IRBs are,
pretty nice.
Some of my colleagues, in the last 5 to 10
years, have been specifically working
with IRBs to, expand their knowledge
of doing community based research.
And some of those strategies are a little bit different
than some of the kind of more clean
cut doing drug trials.
So, depending on what you want to do
and if you're using novel methods
of recruitment and retention, you may need to,
go back and forth with your IRB team.
This concentric circle model of recruitment
is actually from WCG clinical.com.
And the idea here is that most of the time,
especially if you're working in a health care setting, that
inner circle,
the active clinic patients, the patients
that are closest to where you are
and have a relationship with you,
or health care,
agency or a group you are typically going to have,
maybe
not an easy time, but you might have better
access
and a better option of connecting
and offering trials to patients.
Then maybe starting with like a mass
media campaign.
Like I said, I'm actually at Wayne State in
Detroit now.
I used to be at NYU Health System
in New York, and especially during Covid
for a lot of the trials, like some of the,
researchers wanted to go straight
to, like, having advertisements in the subways, right, or on
billboards.
While not a lot of people were actually
riding the subways during Covid,
but that's really expensive, right?
And how many of you have been on the Metro
here in the DC area and saw
an advertisement for a clinical trial
and called and enrolled?
Probably nobody.
I'm not saying it's not theoretically possible,
but the idea here is you don't want to do
the biggest, most expensive thing.
First, you want to try to start as close as possible.
So here would be active clinic patients,
even in active clinic patients.
So think about if you're at I don't know, the NIH Clinical
Center.
Maybe people who've had a history, in the
past,
they may be more open to at least hearing
about research opportunities.
Then, then that circle is referring
clinician,
referring clinician, patients
and then community outreach, which is really, really
important.
And I'm not saying that media outreach
never works.
But again, you don't want to do the most expensive thing
for people in the world who have no idea
who you are in a relationship.
But media sometimes has its place.
Other potential online recruiting strategies
may include social media,
email, EHR record based methods.
I've actually used that before.
At some of my prior institutions,
they have AP, my chart, and within epics.
You can not you yourself, but the health
IT team can activate the, research module
or in the patient portal so you can with IRB approval
and in partnership with your IT team,
you can actually push out direct
to patient invitations via the patient portal.
And if patients are interested, they can click yes, I'm
interested.
And once people who are identified
as interested,
reveal themselves and you're able to correspond
directly via the patient portal, with those interested patients.
I've also done research with online
survey panels such as Donato,
which used to be called Survey Sampling International.
Those type of online panels, in my
opinion, work
better for like more survey research,
kind of broader things.
But it is an option.
You can do paid digital advertisement
or posting on websites.
Sometimes people will hear about something
and forward it to their friends.
Some research, projects
that I am aware of that haven't been directly
involved in
have gotten, permission through their IRB protocol
to actually text patients to,
consider participating in a research
trial,
which that also has implications for fear subject selection.
And when you think about nowadays,
a lot of people do use email,
but a lot of people are very dependent
on their cell phones
and text messaging.
So if that's a good way to reach your audience,
that you may want to consider that.
And then you may want to consider
recruitment registries
such as research match.org.
Research Matt Stork is actually a program
funded by NIH and it's a national registry.
Although people don't have to proactively join
the registry to be to find, research
opportunities.
I actually joined Research Match dot,
four years ago because I was just curious
of how it worked, but
because I'm actually a registered participant,
I get alerts every so often about, you know,
University of San
Francisco has this, study on X, y, Z.
So people, because it's a national,
registry, you may get invitations
if you sign up for it from universities
from across the country.
As of two days ago, there are about 120,000
people across the U.S who have registered
and research matched.
And it's growing.
You can and I think there's like 1500
academic
medical centers that are part of it.
It's fairly simple
to register as an individual, but also as a researcher.
So research matched that.
Org is not the end all, be all.
But for some types of research I think in particular for survey
research,
and for things where people don't
necessarily need to come
into a clinical center, it can be a good resource to
consider.
So, I wanted to just give a few examples.
So I have, most more recently within the last eight years,
been doing more research on hypertension
management and cardiovascular
disease in black adults.
Historically, my early research was actually
on clinical
trial participation of underrepresented groups.
So for my Career development award
when I was actually in New York,
I did focus groups with black patients.
And my primary strategy for recruiting patients was
actually going
through our health system, electronic medical record
and inviting people through the patient portal.
So I only needed like 40 people for that.
But I got like 500 interested people.
So our I.T person and who knows, maybe it was I think it was
partly
because the focus group was relatively straightforward.
I think my description was not overly wordy, but he in his
experience,
he said I got a really quick response,
which was, I guess, sometimes unusual.
You know, the EHR method is helpful,
but it doesn't mean that you're always
going to get people right away.
So I did use invite people through
the patient portal for the focus groups.
I also did a survey of 200, black adults
with hypertension, and I went through
our patient portal again.
But I also utilized research matched at work for the broader
survey.
And I also worked with our
I.T people because for that study also,
I also recruited clinicians.
So they were able to,
help me query like primary care clinicians
within our health system.
And that's interesting to kind of
there's all these different categories
of how doctors are, labeled, I guess within the health
system.
And so they may be in family medicine
or internal medicine.
Some people are in different groups
even though they see patients with hypertension.
So it's also a way to potentially identify
clinicians.
I literally just put in a grant application a couple
weeks ago,
to engage, I'll be where I will be
recruiting,
black patients in the Detroit area
with hypertension,
but I'm going to be focusing on federally qualified health
centers.
So Wayne State does not have and it's it's
not connected to a health system per se.
So I'm working with Independ.
I will be
working is funded with that, independent
federally qualified health center.
And the clinical director, you know, I talked to him
several times
and I said, no.
Is there a way for me to work with your 80% and get a
list?
They said, we are not giving you list of our patients.
But what they have found historically
is that if their own clinicians
bring up trials to their patients
because this is a medically underserved
group, they trust the doctors.
So he said, if you get funded, our
clinicians will,
bring up the study
and do a soft handoff if patients are interested.
He suggested that I create like three by five
cards are really kind of very simple,
plain language description of the study.
And if patients are interested, they'll give a flier
and they will have to contact us.
So my point here is you really have to just work
with whoever,
whatever group you're working with.
And sometimes, like the methodology
is really going to be dependent
on where you are and who you want to work with
and their comfort with kind of the different
methodologies.
So we'll see how that goes.
All right.
So now I want to talk a little bit
about some health literacy considerations,
both for clinical trial communications
and informed consent.
So there through the years
there's been, different definitions of health literacy.
I'm using one from Healthy people 2030.
And they define personal health literacy
as the degree to which individuals
have the ability to find, understand,
and use information and services
to inform health related decisions
and actions for themselves and others.
So when you think about that, kind of like
with our case, with Linda earlier,
with you trying to find a, trial for type
two diabetes,
people differ in, you know, where they would find
information,
how they think about information,
how they understand it,
whether they prefer print or audio
for more visual information.
And, these are some examples of prior
studies that have looked
at the association between clinical trial
participation and health literacy.
So in this first study, anatomy spend too much time.
But, this was a qualitative study
of 20 women with lower health literacy
who were, in who participated
in a phase two trial for early stage
breast cancer.
And what they found was that,
women
with lower literacy were more likely to
report
that they relied on their provider
recommendation on whether or not
they should enroll in a trial, which probably is not, that
surprising.
So if you have trouble with health literacy, you may
be,
more heavily leaning on your clinical team
to advise you
on, you know, if you should maybe consider it
or not
in this,
second study to the right,
those colleagues that was a study of 500 cancer
patients,
and they were actually randomized
to one of four conditions.
So they either got information about randomization
that was in plain language or given a gambling metaphor.
And the gambling metaphor was like a flip of a coin.
There was also what they called a benign metaphor, where they
described,
randomization as
the chance of a pregnant woman having a male or a female child.
And then there was this, control condition.
And what they found was that people
with higher health literacy actually,
preferred, or did better understanding
randomization with the gambling metaphor,
again, the flip of a coin and then that for people with
lower
literacy skills were, actually understood
randomization better when it was
described as a chance of a pregnant woman
having a male or female child.
So again, this is just interesting studies
and things to consider.
And then finally, in this last study,
by Kim and Kim,
they, looked at the randomized
150 people to get to one of two conditions.
They either got a standard consent form
with their calling,
a standard consent form, or more simplified version of a consent
form.
And what they found is overall,
regardless of your health
literacy level, people prefer,
simplification.
And that was really better for everybody.
Again, probably not a surprising finding
if you have the opportunity
to simplify information in a consent form.
Sometimes they can be multiple pages
and small font with
lots of parts, for a lot of legal
and ethical reasons.
But, sometimes it can be very overwhelming.
This,
this, paper
I had the privilege of working with colleagues,
who are broadly in the decision science world.
And, we published this paper really describing a process
for developing a plain language decision
support tool for,
to help people consider participating in cancer clinical
trials.
And we looked at health literacy,
really blending the merger of,
like, health literacy, academic research
and minority patient perspectives.
So this was, like a three phase process.
So in the first phase, we actually did qualitative
interviews
with 45 black and Hispanic cancer
survivors to really understand their,
challenges and opportunities related to clinical trials.
The second part was a, in phase one was a survey of 1100,
cancer survivors.
And then there was a literature review.
And then phase two was really content
generation.
So taking all of that information
learned in phase one to create phase
first prototype of this decision support tool.
And then phase three was usability testing.
And so this paper really just describes
a process for developing,
a decision support tool.
And as part of that same paper,
we proposed or talked
about the Kasama role for cancer clinical trial.
Participate.
And that stands for knowledge empowerment and Values
clarification.
So I won't go over every box because some of these
were, represented in past,
models.
But with decision support tools.
It's really that those middle boxes,
communication skills development
and deliberate action is a really important and really
important
principles in decision making and
also for, decision making and decision aids.
The idea values clarification.
So those are like exercises and questions
to help people think through
what their own personal values are
and what they would perceive
as like the value of participating
in a cancer clinical trial.
So now I just want to shift
just a little bit to building and maintaining
trust.
And this is a quote, from a paper
from my colleague Derek Griffith and colleagues.
And I'm just going to read this out
for you.
Trust, mistrust and distrust influence people's ability to
you trust,
utilize critical resources and make decisions that are best
for their health and well-being.
Trust is necessary for optimizing health
research,
eliminating health health care disparities, and achieving
health equity.
But efforts to build trust to increase
health care utilization and research
participation may have little effort on
attitudes
or behaviors that are rooted and distrust and
mistrust.
And, this paper is not super long,
but they do a really good job
of talking about the concepts of trust,
mistrust, and distrust.
And sometimes in, academic situations
like this,
we use those terms interchangeably.
But the roots of like, mistrust and distrust and even
building,
trust in people who have low trust.
They're really distinct things.
And they really argue that it's important
that we're really precise
about what we're talking about and what we're trying to
intervene on.
This paper,
this is a conceptual model from a paper that Consuela
Wilkins actually had published in 2018.
And what I like about it is that it really focuses on
enhancing
trust in building effective partnerships
with patients and community stakeholders.
And on the left, these are, some of the trust dimensions
and content areas that she posits that are really
important.
None of these should be surprising, but,
I think it's good to,
revisit concepts like it's important.
Honesty is really important for building
trust, communication and, confidence.
So that's really the belief and reliability of all the different
parties
ensuring that people have, confidentiality
that the teams are considered competent,
that there's fairness and fidelity
and safety and system trust.
So the system trust really has to do
with beliefs and institutions
and processes and policies of the whole research
enterprise.
And then the right upper box talks
about characteristics
of trustworthy research researchers.
So really trying to, as best we can be
accessible, approachable, attentive
to the needs and concerns of communities,
empathetic, honest, humble, respectful.
And then that bottom right box,
really is, I think, supportive of some of the principles of
community
engaged research or principles like, cdpr,
but that thinking about things like
power dynamics and really transparency,
how do you create infrastructure and policies to really,
bolster up community stakeholders in the
infrastructure for places that are like
not the NIH Clinical Research Center
or big academic medical centers?
How are resources equally equitably distributed?
Do we have, again, this idea of effective
communication
and really like establishing patterns of fulfilling trust?
And also the notion of shared decision
making among all the partners.
And, really valuing,
different resources and assets, such as lived experience.
So I think not you all, but sometimes as research
groups, we kind of come into communities
or come into partnerships
really, from a place of the information
and resources that we can impart on the
community.
But community also has research,
resources and experiences
that are also equally valuable to the research, enterprise.
I we should honor.
I had, or I have the,
benefit of working with a lot of different
researchers, just,
from where I've been, but also my own research
interests.
So Stacy Loeb is actually a urologist
at NYU Health System and also with the Manhattan VA.
And, she led a project that I was a part of
that was really looking at,
perceive trust in,
online videos about prostate cancer.
So this was a randomized clinical trial.
We actually did this trial
through, DiNardo, which used to be Survey
Sampling International.
So again, using an online survey panel
and how this,
clinical trial was set up where that, participants
were randomized to one of four groups.
So they either, saw a video about cancer
screening or clinical trials
that was presented by either a black physician,
a black patient, a white physician, or a white
patient.
And then they took a questionnaire.
And for this paper, our primary outcome was really
trust
in the information in the videos.
And so we used a validated scale for trust that was called the
group minority
based Mistrust Scale by Haley Thompson.
And really kind of the high point key
finding was that in this clinical trial
of over 2900 US men
and women, black adults were statistically significantly
more likely to trust videos with a black versus a white
presenter.
However, in white adults,
the race of the presenter like was not associated with
trust.
And so I think a take home is from this,
even though it was one setting,
is that representation matters, diversity
matters, not just on research teams,
but in health communication and patient education materials.
So my last few slides are really about points
to consider when you're thinking of
drafting,
recruitment and retention plan for clinical
research.
And this information is from is a really nice, article
that's posted on the National Institute
of Mental Health, website.
And the link is there.
So the first key concept is community
engagement and questions
you can ask yourself.
Although there's lots of questions
in the actual document
is, you know, have you identified
communities that you would like to engage.
So examples could be participants
in their family members.
If you're looking at something like Alzheimer's or like,
Parkinson's support, or community centers,
you also want to think through barriers
to participation.
So what are the barriers and how will you address them.
And it could be things like time off
work or transportation,
or if it's a drug study or some kind of,
change in how people will manage their health
conditions.
They may not want to change their medication plan.
There's also benefits to participation.
And this is really not what we think
as researchers are the benefits.
But what are the kind of perceived
benefits from potential participants.
And one thing that you could do is to work
with communities through focus groups
or interviews or surveys to get their,
self-reported list of what they think
are the potential benefits of whatever project you are
proposing.
They're also informational materials.
So will the study materials account
for different levels
of literacy and cognitive abilities
and suggestions here,
as I mentioned earlier, to the rest,
you can use clear and simple language.
There's also the idea of planning and timeline.
And so if you haven't done research yet,
you know, like the timeline
somehow always seems to be longer
than what we initially think.
So asking yourself as a story or asking yourself
an experience researchers is just a realistic recruitment
timeline.
And then think about like if there are
other local studies in your area,
what are the estimates of eligible participants?
But how successful or not were they in doing similar
research?
There's also the idea of recruitment strategies.
So like what mechanisms will you use
to encourage recruitment.
And then make sure that all staff
who communicate with
potential participants receive proper training and
practice.
There's also retention strategies.
So you want people to enroll, but if you
have a multi month or multi year study,
you want people to stay in the study
to the end as much as possible.
So how will you retain participants?
How are you going to monitor retention
if you have a problem?
One of the ways it seems super simple is to be
flexible
with scheduling appointments.
For example, not everybody can come
to your research center
on a Thursday between 12 and 4 p.m.
get several phone numbers.
So cell phone, home number if possible,
or maybe, from family members and friends
because sometimes people cell phones,
you know, go dead or you can't find them.
So it's good to have multiple phone
numbers to follow up and then to send,
participant small tokens of appreciation
to remind them about your study, especially if it's not a one
time thing.
And then finally,
when the study is over, how are you going to thank
participants?
Acknowledge acknowledge them for their time?
How are you going to disseminate results
to all of the communities involved?
And how will you maintain relationships
that you forged with the community?
So like in my case, I hope I get funded for my,
state intervention study with this
federally qualified health clinic.
So just put in good vibes and I will get fully funded.
But after that, over.
You don't want to be what they call
a helicopter researcher.
Just show up when you need something
and then disappear and then come back ten years
later.
How will you manage that participation?
That relationship.
Send thank you notes to participants
and other communities
that were involved in your study,
and then report results in formats
that are most useful to the communities
involved.
So participants, family members of participants
then also may be referring practice,
practitioners or clinicians.
So I found having worked in several health
systems,
the clinicians do not want long reports.
A lot of times they like very short memos.
Hopefully one page two page match.
So trying to be as concise as possible.
This is
one example of appreciation for being in a clinical trial
and going to talk in just a minute
about my participation
in the phase one clinical trial for the Pfizer Covid 19 vaccine.
I was a participant and there was like
14 visits over two years.
But on my last study visit, even though we got paid
for all of our time and all the visits,
they gave us this little, like, gift box.
And, so that's actually a pain.
It's a little blurry, but it's a little gift box.
And I opened the gift box. I was like, oh, this is so cool.
I actually send it to our marketing
and communications person who's actually my friend.
In New York.
But what they said was, for note in
there was your your courage wrote history.
Today, it's more clear than ever that our survival depends on one
another.
When you became a clinical trial volunteer
for the first Covid
19 vaccine to be approved, you joined
tens of thousands to bring light to a darkened
world.
In honor of your pursuit of hope,
we offer this keepsake.
So it's a little pen, and in the back
it said pursuit of Hope.
And you could write your name in there.
I thought I was probably feeling like extra, like
citizen and Happy, but I was like,
that was like
just a really nice note that we we brought light to a darkened
world.
So anyway, that's just like one example.
And again, I mentioned I was a participant
in Pfizer's phase one, Covid vaccine
clinical trial.
I do not have any stocks or bonds in Pfizer, but,
if you can see here that was, like our first, consent form
and it was 20 pages and like ten point
font,
and I did actually read it all, but it was a lot.
And because there were some minor changes
throughout the study, I think I had like
maybe 2 or 3, updates to the, consent
form.
And I learned a lot, and I'm happy to talk more about
it.
I wanted to be in the clinical trial
for a lot of reasons.
When I believe in vaccines and I was, I was kind of
selfish.
I was like, if if there's going to be a
good,
vaccine or an effective vaccine, I want to be one of the first to
get it.
So even the idea of, like, me knowing where to go to sign up
had, you know, that, I guess with some level of
privilege,
because it wasn't quite obvious at the beginning.
But I also had friends who got really sick from Covid.
And I have the time, so I just wanted to contribute.
But I also learned a lot, as a researcher
who has done clinical research,
being a participant and kind of going through
all of those steps, it was very eye opening.
I think I had a good,
I personally had a good experience,
but it's a lot, to do all of that.
So I'm happy to talk about it.
But as part of my own participation
in the Pfizer,
phase one study, and then also at that time
doing a lot of clinical trials and education about the need
for clinical trial participation for the safe, vaccine trials,
but also after it was approved, talking a lot to communities
about considering considering getting vaccinated.
It actually informed, a line of research.
So I actually,
have another
grant application under review about enhancing
or reducing vaccine hesitancy for flu
and Covid.
Vaccines.
And here this is really just, a simplified graph that, you
know, there
in terms of vaccine acceptance, there are
some people who refuse all vaccines,
some who refuse certain vaccines,
some people who will just delay vaccines.
You may accept vaccinations but have concerns.
So like if you work for health system
that requires the flu shot, you may be
very concerned about the flu shot,
but you may need to.
You need to keep your job and pay your bills.
And you have people like me that you know,
there's a million things to be worried about.
I'm personally not worried about vaccines,
so I pretty much get all the age appropriate vaccines I can get.
But maybe I'm like a weird bird or whatever.
So my last example here,
this is a real study
of, looking at low pathogenic, tenacity
for avian, A10997
influenza virus in a healthy human
challenge model.
So, for those who are not familiar with,
human challenge trials, essentially what they're
doing
is purposely infecting people with the virus who are healthy.
And then I don't want to say to see what happens, but
looking at the immune response in those people.
So these folks have to be willing
to be infected with the virus, like flu.
And, this I think recruitment is actually wrapping up soon,
but this is a trial that's, being funded
and done right here at NIH.
If you, are interested, you can actually look at that QR
code.
I'm going to tell you what some of the requirements are.
So you have to be a healthy person
between 18 and 50.
You actually also, if you choose to do it,
you will get compensated.
But if you choose to do this human trial,
challenge, trial,
you actually have to do a prescreening call
and then you have to come to the NIH Clinical Center in
Bethesda.
And, you have to stay nine days in the inpatient hospital.
And then there's four outpatient follow up visits.
So eight, 18 and 59 days to be here
at NIH, in the hospital in four, because that's everybody.
So and you guys are in research, I'm sure you would sign up right
now
because you support the mission of NIH.
And this next,
slide, really just if you go to
clinicaltrials.gov,
this is where I pulled it from.
They get background about really the flu
and why it's important.
But what they're actually doing, they want to find the smallest
dose
of this influenza virus that may cause uncomplicated,
mild to moderate flu infection in healthy people.
And this dose will be used to inform,
how like the next flu viruses or flu vaccines will work.
If you were in charge of the recruitment
and retention plan for this human
challenge study, where we try to recruit
people again, they have to be 18 and 50.
They have to be willing to stay in the NIH
Clinical Center
hospital for nine days, and then come back
for four different visits.
They are compensated,
but the compensation amount was not on the website,
so I don't know how much they're actually compensating.
I don't know if I was in charge of recruitment and retention
where I have to go, because you essentially have
to have healthy people in the world
who are going to be willing
to be infected with the virus.
And it was interesting early on when,
like the first year of Covid,
the medical ethics group, where I was
before at NYU, they actually had us
symposium on should they have human challenge trials for
Covid?
And most people said no, because we have
no flight experience or mitigation.
But there were philosophical questions of
would it be ethical
during 2020 to infect people with Covid
19 to inform, treatment development?
It just thought that was an interesting
trial to think about.