1 00:00:11,845 --> 00:00:13,964 I'm really excited to be talking with you 2 00:00:13,964 --> 00:00:14,481 all today 3 00:00:14,481 --> 00:00:16,867 about the bride issue of recruitment 4 00:00:16,867 --> 00:00:19,386 and retention into clinical research, 5 00:00:19,753 --> 00:00:22,756 and health research studies. 6 00:00:23,190 --> 00:00:25,759 So I have no relative 7 00:00:25,759 --> 00:00:28,661 or relevant financial relationships to 8 00:00:28,661 --> 00:00:29,196 report 9 00:00:29,196 --> 00:00:32,366 or conflicts of interest. 10 00:00:32,366 --> 00:00:35,402 And just to get us started, 11 00:00:35,402 --> 00:00:38,680 you all probably know this, but clinical trials are not just one 12 00:00:38,680 --> 00:00:39,039 thing. 13 00:00:39,606 --> 00:00:42,376 They are diverse and hype and topic. 14 00:00:42,376 --> 00:00:45,812 So for example, there are behavioral studies. 15 00:00:45,812 --> 00:00:47,281 There are genetic studies. 16 00:00:47,281 --> 00:00:49,660 There are people who choose to participate 17 00:00:49,660 --> 00:00:50,284 in surgery 18 00:00:50,284 --> 00:00:52,734 studies or drug trials or vaccine trials 19 00:00:52,734 --> 00:00:54,388 or trials that are focused 20 00:00:54,388 --> 00:00:57,958 on social social support or like symptom management. 21 00:00:58,859 --> 00:01:01,628 There are also different phases of clinical trials. 22 00:01:01,628 --> 00:01:04,598 So phase one, face to face three. 23 00:01:04,598 --> 00:01:06,668 I, I'm going to talk about this later, 24 00:01:06,668 --> 00:01:08,302 but I have been a participant 25 00:01:08,302 --> 00:01:11,305 in a phase one vaccine trial 26 00:01:11,505 --> 00:01:14,341 and it the target populations can differ. 27 00:01:14,341 --> 00:01:17,511 In some situations we are focusing on children. 28 00:01:17,911 --> 00:01:20,050 In some situations we may have a focus 29 00:01:20,050 --> 00:01:21,682 on older adults or families. 30 00:01:22,115 --> 00:01:25,719 And in some situations we may actually be focusing, 31 00:01:26,386 --> 00:01:29,656 exclusively or primarily on pregnant women. 32 00:01:33,360 --> 00:01:35,095 So before 33 00:01:35,095 --> 00:01:37,965 we actually get started, 34 00:01:37,965 --> 00:01:40,300 just imagine that you have a neighbor. 35 00:01:40,300 --> 00:01:43,156 Her name is Wanda, and she knows that you either 36 00:01:43,156 --> 00:01:43,870 work at NIH 37 00:01:43,870 --> 00:01:46,084 or very interested in clinical trials 38 00:01:46,084 --> 00:01:47,341 and health research. 39 00:01:47,341 --> 00:01:49,747 And she's trying to find a clinical trial 40 00:01:49,747 --> 00:01:52,212 for people living with type two diabetes. 41 00:01:52,646 --> 00:01:54,756 And if she came to your door, tonight 42 00:01:54,756 --> 00:01:57,150 and asked her help, where would you start 43 00:01:57,851 --> 00:02:01,455 if you wanted to help her find a clinical trial for type two 44 00:02:01,455 --> 00:02:02,055 diabetes? 45 00:02:02,322 --> 00:02:04,624 Of all of these places, where would you start? 46 00:02:04,624 --> 00:02:06,907 And we'll talk a little bit about that 47 00:02:06,907 --> 00:02:07,627 more later. 48 00:02:07,961 --> 00:02:10,430 So the before we kind of get in-depth 49 00:02:10,430 --> 00:02:13,794 into strategies and, ways of recruitment and 50 00:02:13,794 --> 00:02:14,634 retention, 51 00:02:14,634 --> 00:02:17,738 I want to just highlight a few example models. 52 00:02:19,106 --> 00:02:21,775 So this model by Ford 53 00:02:21,775 --> 00:02:25,545 and colleagues is actually one of the first clinical trial, 54 00:02:25,746 --> 00:02:28,058 conceptual frameworks I became aware of, 55 00:02:28,058 --> 00:02:29,850 when I was a doctoral student. 56 00:02:30,283 --> 00:02:32,552 And broadly, they posit that, 57 00:02:34,087 --> 00:02:36,390 barriers can be categorized 58 00:02:36,390 --> 00:02:39,042 as awareness barriers or promoters, 59 00:02:39,042 --> 00:02:41,695 opportunity barriers or promoters. 60 00:02:41,695 --> 00:02:44,698 And then acceptance or refusal. So, 61 00:02:45,966 --> 00:02:48,969 awareness opportunities and things that can, 62 00:02:49,603 --> 00:02:52,180 potentially impact people's decision to 63 00:02:52,180 --> 00:02:53,040 participate. 64 00:02:53,040 --> 00:02:55,742 So this is one of the earlier earliest frameworks 65 00:02:55,742 --> 00:02:58,415 that I have been aware of, although I'm sure there are 66 00:02:58,415 --> 00:02:58,712 many. 67 00:02:59,179 --> 00:03:02,182 So just keep that in the back of your mind. 68 00:03:02,582 --> 00:03:04,418 And then, more recent. 69 00:03:04,418 --> 00:03:07,521 Well, relatively more recently, the prior one was published 70 00:03:07,788 --> 00:03:11,091 online in 2007 and then in print in 2008. 71 00:03:11,591 --> 00:03:15,295 And in 2021, Wilkins and colleagues, 72 00:03:15,996 --> 00:03:19,647 as part of their involvement with the Recruitment Innovation 73 00:03:19,647 --> 00:03:20,133 Center. 74 00:03:21,001 --> 00:03:23,060 Their recruitment Innovation center 75 00:03:23,060 --> 00:03:25,472 is actually part of the Trial Innovation 76 00:03:25,472 --> 00:03:27,737 Network, which is actually funded 77 00:03:27,737 --> 00:03:30,277 by the National Center for Advancing 78 00:03:30,610 --> 00:03:34,247 Translational Sciences, and that's part of NIH. 79 00:03:34,548 --> 00:03:37,851 So they, put forth this conceptual model 80 00:03:38,251 --> 00:03:41,288 of, participant recruitment efforts. 81 00:03:41,288 --> 00:03:44,057 And most of these are pretty explanatory. 82 00:03:44,057 --> 00:03:47,269 So there's awareness, how they conceptualize 83 00:03:47,269 --> 00:03:48,728 feasibility is more 84 00:03:49,096 --> 00:03:52,450 from the concept of making sure you have enough of an eligible 85 00:03:52,450 --> 00:03:53,100 population. 86 00:03:53,100 --> 00:03:55,265 So you may be accessing feasibility 87 00:03:55,265 --> 00:03:56,503 through things like 88 00:03:56,503 --> 00:03:59,142 electronic health records, making sure you have a big 89 00:03:59,142 --> 00:03:59,739 enough pool 90 00:04:00,574 --> 00:04:03,543 opportunity, very similar to the past models 91 00:04:03,543 --> 00:04:05,959 like do people know that these opportunities are 92 00:04:05,959 --> 00:04:06,513 available? 93 00:04:07,047 --> 00:04:09,783 Then there's screening implications. 94 00:04:09,783 --> 00:04:11,551 Invitation to participate. 95 00:04:11,551 --> 00:04:13,768 So it's great to have clinical trials in the 96 00:04:13,768 --> 00:04:14,121 world, 97 00:04:14,121 --> 00:04:16,523 but you have to have ways to invite patients and 98 00:04:16,523 --> 00:04:17,224 participants. 99 00:04:17,991 --> 00:04:19,426 Then there's consent. 100 00:04:19,426 --> 00:04:22,064 Hopefully if people are well consented 101 00:04:22,064 --> 00:04:23,730 and think this through, 102 00:04:23,730 --> 00:04:25,939 they will go on to enroll in the trial 103 00:04:25,939 --> 00:04:27,567 and then there's engagement 104 00:04:27,567 --> 00:04:29,102 and retention throughout the trial. 105 00:04:29,102 --> 00:04:30,770 So it's really about communication 106 00:04:30,770 --> 00:04:33,607 and making people feel like they have some sense of 107 00:04:33,607 --> 00:04:34,441 connectedness. 108 00:04:34,775 --> 00:04:38,245 And then they talk about return of value 109 00:04:38,545 --> 00:04:40,747 and how they conceptualize return of value. 110 00:04:40,747 --> 00:04:44,151 Is this idea of getting or giving back 111 00:04:44,151 --> 00:04:47,163 individual results and also study results to 112 00:04:47,163 --> 00:04:48,121 participants? 113 00:04:48,655 --> 00:04:50,937 Even if they're if it's not clinically 114 00:04:50,937 --> 00:04:51,658 meaningful, 115 00:04:51,892 --> 00:04:55,795 but they talk about really this return of information, 116 00:04:56,563 --> 00:05:00,719 as respecting or, uplifting the idea of respect 117 00:05:00,719 --> 00:05:01,868 for persons. 118 00:05:05,071 --> 00:05:06,640 And then finally, this is 119 00:05:06,640 --> 00:05:10,944 actually my conceptual model, which ironically, I had, 120 00:05:11,178 --> 00:05:14,147 published in a special supplement focused 121 00:05:14,147 --> 00:05:17,317 on vaccines, clinical trials. 122 00:05:17,317 --> 00:05:19,178 So this was in the Journal of Health 123 00:05:19,178 --> 00:05:19,953 Communication. 124 00:05:19,953 --> 00:05:22,474 And so this is actually, a general model 125 00:05:22,474 --> 00:05:24,491 of clinical trial participation 126 00:05:24,491 --> 00:05:27,727 that have been developing actually for many years 127 00:05:27,727 --> 00:05:30,797 and finally got it published in this, during Covid. 128 00:05:30,797 --> 00:05:33,934 I'm not going to go over every single bullet point, 129 00:05:33,934 --> 00:05:36,675 but I just want, us to just appreciate 130 00:05:36,675 --> 00:05:38,838 that a lot of things happened 131 00:05:38,838 --> 00:05:43,977 between us as researchers creating a clinical trial. 132 00:05:43,977 --> 00:05:46,768 Trial idea, and people actually enrolling 133 00:05:46,768 --> 00:05:49,082 or getting to the end of a trial. 134 00:05:49,382 --> 00:05:52,118 And in particular, I like to pay 135 00:05:52,118 --> 00:05:54,158 a lot of attention to clinical trial 136 00:05:54,158 --> 00:05:55,121 characteristics. 137 00:05:55,121 --> 00:05:57,841 So the decisions that we make, often 138 00:05:57,841 --> 00:05:59,125 as, study teams, 139 00:05:59,459 --> 00:06:03,374 in terms of the intervention and how many procedures and 140 00:06:03,374 --> 00:06:03,863 things 141 00:06:03,863 --> 00:06:07,100 like number of study visits and incentives, all of those 142 00:06:07,100 --> 00:06:09,415 clinical trial characteristics impacts 143 00:06:09,415 --> 00:06:10,937 people's willingness or, 144 00:06:12,239 --> 00:06:14,708 availability or, 145 00:06:14,708 --> 00:06:17,711 really access to do the things we're asking them to do. 146 00:06:17,711 --> 00:06:20,190 And then I also like to highlight, really 147 00:06:20,190 --> 00:06:22,549 the communication throughout the trial 148 00:06:22,549 --> 00:06:24,319 is very important to thinking about 149 00:06:24,319 --> 00:06:25,685 how will you reach people. 150 00:06:26,052 --> 00:06:28,621 Who's your audience, what's the context and the 151 00:06:28,621 --> 00:06:29,222 messaging. 152 00:06:29,222 --> 00:06:33,177 And then at the really effort and a lot of things that we 153 00:06:33,177 --> 00:06:33,593 think 154 00:06:33,593 --> 00:06:37,280 about as researchers are, you know, did people decline or 155 00:06:37,280 --> 00:06:37,797 enroll? 156 00:06:38,531 --> 00:06:40,667 How much retention did we have. 157 00:06:40,667 --> 00:06:44,004 And, as someone who studies medical decision making, 158 00:06:44,004 --> 00:06:47,540 I'm often interested in do people have decision regret? 159 00:06:47,774 --> 00:06:50,777 So if you're in a trial and everything went well, 160 00:06:51,711 --> 00:06:53,827 you probably okay if things didn't quite 161 00:06:53,827 --> 00:06:56,049 go so well, you may have decision regret, 162 00:06:56,349 --> 00:06:57,317 but if you 163 00:06:57,317 --> 00:06:59,386 in principle had a very good informed 164 00:06:59,386 --> 00:07:01,454 consent process, you will know that. 165 00:07:01,655 --> 00:07:04,440 You know, things may not go perfectly 166 00:07:04,440 --> 00:07:04,891 well, 167 00:07:04,891 --> 00:07:07,004 but if you've had a good consent process, 168 00:07:07,004 --> 00:07:08,962 those expectations should be managed. 169 00:07:11,197 --> 00:07:14,200 As part of that same, 170 00:07:14,401 --> 00:07:17,904 paper that I, had published of my general model 171 00:07:17,904 --> 00:07:22,142 of clinical trial participation, I also put forth this ask 172 00:07:22,142 --> 00:07:25,478 approach for enhancing clinical trial participation. 173 00:07:25,478 --> 00:07:29,349 And as some of you know, more contemporary research 174 00:07:29,549 --> 00:07:33,186 has been showing that particularly for minority 175 00:07:33,186 --> 00:07:35,111 groups and underrepresented groups, 176 00:07:35,111 --> 00:07:37,090 the narrative historically has been 177 00:07:37,090 --> 00:07:39,630 people are afraid, they have mistrust, they have 178 00:07:39,630 --> 00:07:40,160 distrust. 179 00:07:40,160 --> 00:07:43,296 And all of that is true, that that is a component. 180 00:07:43,296 --> 00:07:46,466 But a lot of research has shown that people are just often 181 00:07:46,466 --> 00:07:48,396 literally not asked to participate 182 00:07:48,396 --> 00:07:50,270 and not given the opportunities. 183 00:07:50,270 --> 00:07:52,772 So it stands for just assume 184 00:07:52,772 --> 00:07:55,475 that all patients want to know their options, 185 00:07:55,475 --> 00:07:58,211 even if one of their options is a clinical trial. 186 00:07:58,211 --> 00:08:00,400 And we can, have faith that they're able 187 00:08:00,400 --> 00:08:02,315 to make a decision about their own 188 00:08:02,649 --> 00:08:05,919 healthcare plan, potentially including the option of a trial. 189 00:08:07,053 --> 00:08:07,787 We also want 190 00:08:07,787 --> 00:08:10,790 to seek the counsel of stakeholders. 191 00:08:11,191 --> 00:08:13,828 And at my next slide, we'll talk a little bit more 192 00:08:13,828 --> 00:08:14,461 about that. 193 00:08:14,894 --> 00:08:18,031 And then the K stands for Know Your numbers. 194 00:08:18,031 --> 00:08:19,889 And I'm not talking about your blood 195 00:08:19,889 --> 00:08:21,901 pressure numbers or your triglycerides 196 00:08:21,901 --> 00:08:22,569 or things like that. 197 00:08:22,569 --> 00:08:25,505 Although you should get your general checkups. 198 00:08:25,505 --> 00:08:28,241 This is really about knowing 199 00:08:28,241 --> 00:08:30,268 and not only your power calculations, 200 00:08:30,268 --> 00:08:31,144 how many people 201 00:08:31,144 --> 00:08:33,881 you'll need to be in a study, but also what is your 202 00:08:33,881 --> 00:08:34,848 theoretical pool. 203 00:08:35,215 --> 00:08:37,023 So if you work with a biostatistician 204 00:08:37,023 --> 00:08:38,685 and they say you're going to need 205 00:08:38,685 --> 00:08:42,522 300 people with lupus who are left handed 206 00:08:42,756 --> 00:08:47,594 and live in Bethesda, Maryland, if you need 300 people, 207 00:08:47,594 --> 00:08:50,436 but you've only seen 50 people per year 208 00:08:50,436 --> 00:08:53,133 in the last three years, that's 150. 209 00:08:53,133 --> 00:08:54,840 You're already going to have a problem 210 00:08:54,840 --> 00:08:56,503 before you start, because you didn't 211 00:08:56,503 --> 00:08:59,022 really think about what your theoretical 212 00:08:59,022 --> 00:09:00,974 pool of people is going to be. 213 00:09:01,341 --> 00:09:04,076 Now, clearly, just because you have enough 214 00:09:04,076 --> 00:09:05,378 people doesn't mean 215 00:09:05,378 --> 00:09:08,341 they're all going to say yes, but at least have to have a big 216 00:09:08,341 --> 00:09:08,681 enough 217 00:09:08,681 --> 00:09:11,151 theoretical pool to, recruit whatever 218 00:09:11,151 --> 00:09:13,753 sample size you believe is sufficient. 219 00:09:15,388 --> 00:09:17,023 So stakeholders 220 00:09:17,023 --> 00:09:21,694 may include, but are not limited to all of these bullet points. 221 00:09:21,995 --> 00:09:25,765 Each time I give this talk, someone comes up with another 222 00:09:25,765 --> 00:09:28,768 stakeholder group that I should think of. But, 223 00:09:28,968 --> 00:09:31,367 in the last round, one of the last talks 224 00:09:31,367 --> 00:09:33,106 I gave, when of my community 225 00:09:33,940 --> 00:09:35,531 partners said, you know, you should 226 00:09:35,531 --> 00:09:37,076 include community health workers. 227 00:09:37,076 --> 00:09:40,113 So, depending on your research study, 228 00:09:40,113 --> 00:09:43,016 you may not need to include all of these people. 229 00:09:43,016 --> 00:09:45,919 But I was involved with a lot of consultations, 230 00:09:45,919 --> 00:09:48,742 particularly, for some of the Covid clinical 231 00:09:48,742 --> 00:09:49,255 trials. 232 00:09:49,622 --> 00:09:53,493 And in addition to patients and researchers, 233 00:09:53,493 --> 00:09:56,073 we worked a lot with our communications 234 00:09:56,073 --> 00:09:57,397 and marketing folks 235 00:09:57,397 --> 00:10:00,400 because we did a lot of public advertisement. 236 00:10:00,633 --> 00:10:03,236 If you are going to be querying your electronic health 237 00:10:03,236 --> 00:10:06,773 record, you may need to, connect to work with your health. 238 00:10:06,773 --> 00:10:08,408 IT people. 239 00:10:08,408 --> 00:10:11,289 Almost everyone here is going to interact with 240 00:10:11,289 --> 00:10:11,978 their IRB. 241 00:10:11,978 --> 00:10:13,413 But, some, 242 00:10:14,981 --> 00:10:17,951 IRBs are, 243 00:10:17,951 --> 00:10:18,852 pretty nice. 244 00:10:18,852 --> 00:10:21,094 Some of my colleagues, in the last 5 to 10 245 00:10:21,094 --> 00:10:23,123 years, have been specifically working 246 00:10:23,123 --> 00:10:25,762 with IRBs to, expand their knowledge 247 00:10:25,762 --> 00:10:28,328 of doing community based research. 248 00:10:28,695 --> 00:10:31,531 And some of those strategies are a little bit different 249 00:10:31,531 --> 00:10:33,444 than some of the kind of more clean 250 00:10:33,444 --> 00:10:34,701 cut doing drug trials. 251 00:10:34,701 --> 00:10:36,966 So, depending on what you want to do 252 00:10:36,966 --> 00:10:39,105 and if you're using novel methods 253 00:10:39,105 --> 00:10:42,108 of recruitment and retention, you may need to, 254 00:10:42,375 --> 00:10:45,378 go back and forth with your IRB team. 255 00:10:46,579 --> 00:10:49,516 This concentric circle model of recruitment 256 00:10:49,516 --> 00:10:54,187 is actually from WCG clinical.com. 257 00:10:54,420 --> 00:10:58,858 And the idea here is that most of the time, 258 00:10:58,858 --> 00:11:01,798 especially if you're working in a health care setting, that 259 00:11:01,798 --> 00:11:02,495 inner circle, 260 00:11:02,495 --> 00:11:04,443 the active clinic patients, the patients 261 00:11:04,443 --> 00:11:06,099 that are closest to where you are 262 00:11:06,366 --> 00:11:08,388 and have a relationship with you, 263 00:11:08,388 --> 00:11:09,369 or health care, 264 00:11:09,636 --> 00:11:13,139 agency or a group you are typically going to have, 265 00:11:14,173 --> 00:11:14,440 maybe 266 00:11:14,440 --> 00:11:17,109 not an easy time, but you might have better 267 00:11:17,109 --> 00:11:17,544 access 268 00:11:17,544 --> 00:11:19,896 and a better option of connecting 269 00:11:19,896 --> 00:11:22,248 and offering trials to patients. 270 00:11:22,248 --> 00:11:24,743 Then maybe starting with like a mass 271 00:11:24,743 --> 00:11:25,852 media campaign. 272 00:11:26,786 --> 00:11:29,118 Like I said, I'm actually at Wayne State in 273 00:11:29,118 --> 00:11:29,822 Detroit now. 274 00:11:29,822 --> 00:11:31,935 I used to be at NYU Health System 275 00:11:31,935 --> 00:11:34,561 in New York, and especially during Covid 276 00:11:34,827 --> 00:11:37,096 for a lot of the trials, like some of the, 277 00:11:37,096 --> 00:11:38,932 researchers wanted to go straight 278 00:11:38,932 --> 00:11:42,602 to, like, having advertisements in the subways, right, or on 279 00:11:42,602 --> 00:11:43,336 billboards. 280 00:11:43,336 --> 00:11:45,487 While not a lot of people were actually 281 00:11:45,487 --> 00:11:47,307 riding the subways during Covid, 282 00:11:47,540 --> 00:11:49,142 but that's really expensive, right? 283 00:11:49,142 --> 00:11:51,704 And how many of you have been on the Metro 284 00:11:51,704 --> 00:11:53,413 here in the DC area and saw 285 00:11:53,413 --> 00:11:55,225 an advertisement for a clinical trial 286 00:11:55,225 --> 00:11:56,449 and called and enrolled? 287 00:11:58,217 --> 00:11:58,985 Probably nobody. 288 00:11:58,985 --> 00:12:01,321 I'm not saying it's not theoretically possible, 289 00:12:01,321 --> 00:12:03,337 but the idea here is you don't want to do 290 00:12:03,337 --> 00:12:05,058 the biggest, most expensive thing. 291 00:12:05,058 --> 00:12:08,261 First, you want to try to start as close as possible. 292 00:12:08,261 --> 00:12:10,578 So here would be active clinic patients, 293 00:12:10,578 --> 00:12:12,432 even in active clinic patients. 294 00:12:12,432 --> 00:12:16,977 So think about if you're at I don't know, the NIH Clinical 295 00:12:16,977 --> 00:12:17,604 Center. 296 00:12:18,338 --> 00:12:21,132 Maybe people who've had a history, in the 297 00:12:21,132 --> 00:12:21,541 past, 298 00:12:21,541 --> 00:12:23,333 they may be more open to at least hearing 299 00:12:23,333 --> 00:12:24,644 about research opportunities. 300 00:12:25,111 --> 00:12:27,396 Then, then that circle is referring 301 00:12:27,396 --> 00:12:28,114 clinician, 302 00:12:28,715 --> 00:12:31,351 referring clinician, patients 303 00:12:31,351 --> 00:12:33,829 and then community outreach, which is really, really 304 00:12:33,829 --> 00:12:34,354 important. 305 00:12:34,654 --> 00:12:36,444 And I'm not saying that media outreach 306 00:12:36,444 --> 00:12:37,056 never works. 307 00:12:37,056 --> 00:12:40,126 But again, you don't want to do the most expensive thing 308 00:12:40,593 --> 00:12:42,341 for people in the world who have no idea 309 00:12:42,341 --> 00:12:43,696 who you are in a relationship. 310 00:12:44,864 --> 00:12:47,867 But media sometimes has its place. 311 00:12:48,434 --> 00:12:52,171 Other potential online recruiting strategies 312 00:12:52,472 --> 00:12:55,375 may include social media, 313 00:12:55,375 --> 00:12:58,144 email, EHR record based methods. 314 00:12:58,144 --> 00:13:00,813 I've actually used that before. 315 00:13:00,813 --> 00:13:03,449 At some of my prior institutions, 316 00:13:03,449 --> 00:13:08,388 they have AP, my chart, and within epics. 317 00:13:08,655 --> 00:13:12,007 You can not you yourself, but the health 318 00:13:12,007 --> 00:13:15,528 IT team can activate the, research module 319 00:13:15,795 --> 00:13:19,966 or in the patient portal so you can with IRB approval 320 00:13:19,966 --> 00:13:21,677 and in partnership with your IT team, 321 00:13:21,677 --> 00:13:23,202 you can actually push out direct 322 00:13:23,202 --> 00:13:26,239 to patient invitations via the patient portal. 323 00:13:26,506 --> 00:13:29,080 And if patients are interested, they can click yes, I'm 324 00:13:29,080 --> 00:13:29,642 interested. 325 00:13:29,909 --> 00:13:32,664 And once people who are identified 326 00:13:32,664 --> 00:13:33,880 as interested, 327 00:13:34,914 --> 00:13:37,717 reveal themselves and you're able to correspond 328 00:13:37,717 --> 00:13:41,988 directly via the patient portal, with those interested patients. 329 00:13:42,255 --> 00:13:44,950 I've also done research with online 330 00:13:44,950 --> 00:13:47,260 survey panels such as Donato, 331 00:13:47,260 --> 00:13:51,097 which used to be called Survey Sampling International. 332 00:13:52,365 --> 00:13:54,445 Those type of online panels, in my 333 00:13:54,445 --> 00:13:55,301 opinion, work 334 00:13:55,301 --> 00:13:57,042 better for like more survey research, 335 00:13:57,042 --> 00:13:58,171 kind of broader things. 336 00:13:58,171 --> 00:14:00,740 But it is an option. 337 00:14:00,740 --> 00:14:03,229 You can do paid digital advertisement 338 00:14:03,229 --> 00:14:04,844 or posting on websites. 339 00:14:05,511 --> 00:14:07,473 Sometimes people will hear about something 340 00:14:07,473 --> 00:14:09,015 and forward it to their friends. 341 00:14:09,716 --> 00:14:12,719 Some research, projects 342 00:14:13,219 --> 00:14:15,669 that I am aware of that haven't been directly 343 00:14:15,669 --> 00:14:16,322 involved in 344 00:14:16,622 --> 00:14:20,259 have gotten, permission through their IRB protocol 345 00:14:20,259 --> 00:14:23,262 to actually text patients to, 346 00:14:24,630 --> 00:14:26,390 consider participating in a research 347 00:14:26,390 --> 00:14:26,733 trial, 348 00:14:26,733 --> 00:14:30,903 which that also has implications for fear subject selection. 349 00:14:30,903 --> 00:14:32,871 And when you think about nowadays, 350 00:14:32,871 --> 00:14:34,607 a lot of people do use email, 351 00:14:34,607 --> 00:14:36,670 but a lot of people are very dependent 352 00:14:36,670 --> 00:14:37,810 on their cell phones 353 00:14:37,810 --> 00:14:38,678 and text messaging. 354 00:14:38,678 --> 00:14:41,781 So if that's a good way to reach your audience, 355 00:14:41,781 --> 00:14:44,217 that you may want to consider that. 356 00:14:44,217 --> 00:14:46,006 And then you may want to consider 357 00:14:46,006 --> 00:14:47,253 recruitment registries 358 00:14:47,587 --> 00:14:50,389 such as research match.org. 359 00:14:50,389 --> 00:14:53,493 Research Matt Stork is actually a program 360 00:14:53,493 --> 00:14:57,964 funded by NIH and it's a national registry. 361 00:14:57,964 --> 00:15:01,768 Although people don't have to proactively join 362 00:15:01,768 --> 00:15:04,759 the registry to be to find, research 363 00:15:04,759 --> 00:15:06,005 opportunities. 364 00:15:06,405 --> 00:15:09,108 I actually joined Research Match dot, 365 00:15:09,108 --> 00:15:11,128 four years ago because I was just curious 366 00:15:11,128 --> 00:15:12,211 of how it worked, but 367 00:15:12,211 --> 00:15:14,447 because I'm actually a registered participant, 368 00:15:14,447 --> 00:15:17,750 I get alerts every so often about, you know, 369 00:15:18,751 --> 00:15:19,685 University of San 370 00:15:19,685 --> 00:15:23,222 Francisco has this, study on X, y, Z. 371 00:15:23,222 --> 00:15:26,192 So people, because it's a national, 372 00:15:27,026 --> 00:15:31,030 registry, you may get invitations 373 00:15:31,030 --> 00:15:33,185 if you sign up for it from universities 374 00:15:33,185 --> 00:15:34,567 from across the country. 375 00:15:35,301 --> 00:15:38,971 As of two days ago, there are about 120,000 376 00:15:38,971 --> 00:15:41,469 people across the U.S who have registered 377 00:15:41,469 --> 00:15:42,809 and research matched. 378 00:15:42,809 --> 00:15:44,443 And it's growing. 379 00:15:44,443 --> 00:15:47,691 You can and I think there's like 1500 380 00:15:47,691 --> 00:15:48,481 academic 381 00:15:48,481 --> 00:15:51,150 medical centers that are part of it. 382 00:15:51,150 --> 00:15:53,753 It's fairly simple 383 00:15:53,753 --> 00:15:58,090 to register as an individual, but also as a researcher. 384 00:15:58,357 --> 00:15:59,959 So research matched that. 385 00:15:59,959 --> 00:16:01,627 Org is not the end all, be all. 386 00:16:01,627 --> 00:16:05,169 But for some types of research I think in particular for survey 387 00:16:05,169 --> 00:16:05,731 research, 388 00:16:06,365 --> 00:16:07,865 and for things where people don't 389 00:16:07,865 --> 00:16:09,001 necessarily need to come 390 00:16:09,001 --> 00:16:12,332 into a clinical center, it can be a good resource to 391 00:16:12,332 --> 00:16:12,972 consider. 392 00:16:16,542 --> 00:16:19,979 So, I wanted to just give a few examples. 393 00:16:19,979 --> 00:16:24,784 So I have, most more recently within the last eight years, 394 00:16:25,184 --> 00:16:27,606 been doing more research on hypertension 395 00:16:27,606 --> 00:16:29,422 management and cardiovascular 396 00:16:29,422 --> 00:16:31,023 disease in black adults. 397 00:16:31,023 --> 00:16:33,173 Historically, my early research was actually 398 00:16:33,173 --> 00:16:33,759 on clinical 399 00:16:33,759 --> 00:16:36,829 trial participation of underrepresented groups. 400 00:16:36,829 --> 00:16:39,149 So for my Career development award 401 00:16:39,149 --> 00:16:41,400 when I was actually in New York, 402 00:16:42,368 --> 00:16:44,937 I did focus groups with black patients. 403 00:16:44,937 --> 00:16:48,418 And my primary strategy for recruiting patients was 404 00:16:48,418 --> 00:16:49,442 actually going 405 00:16:49,442 --> 00:16:52,478 through our health system, electronic medical record 406 00:16:52,478 --> 00:16:54,580 and inviting people through the patient portal. 407 00:16:54,580 --> 00:16:57,250 So I only needed like 40 people for that. 408 00:16:57,250 --> 00:17:00,887 But I got like 500 interested people. 409 00:17:00,887 --> 00:17:04,084 So our I.T person and who knows, maybe it was I think it was 410 00:17:04,084 --> 00:17:04,457 partly 411 00:17:04,891 --> 00:17:08,661 because the focus group was relatively straightforward. 412 00:17:08,661 --> 00:17:12,449 I think my description was not overly wordy, but he in his 413 00:17:12,449 --> 00:17:13,232 experience, 414 00:17:13,232 --> 00:17:15,538 he said I got a really quick response, 415 00:17:15,538 --> 00:17:17,904 which was, I guess, sometimes unusual. 416 00:17:18,204 --> 00:17:21,140 You know, the EHR method is helpful, 417 00:17:21,140 --> 00:17:22,788 but it doesn't mean that you're always 418 00:17:22,788 --> 00:17:24,176 going to get people right away. 419 00:17:24,176 --> 00:17:26,203 So I did use invite people through 420 00:17:26,203 --> 00:17:28,648 the patient portal for the focus groups. 421 00:17:28,948 --> 00:17:32,852 I also did a survey of 200, black adults 422 00:17:32,852 --> 00:17:35,105 with hypertension, and I went through 423 00:17:35,105 --> 00:17:36,689 our patient portal again. 424 00:17:36,689 --> 00:17:40,340 But I also utilized research matched at work for the broader 425 00:17:40,340 --> 00:17:40,826 survey. 426 00:17:42,028 --> 00:17:43,863 And I also worked with our 427 00:17:43,863 --> 00:17:46,274 I.T people because for that study also, 428 00:17:46,274 --> 00:17:48,067 I also recruited clinicians. 429 00:17:48,367 --> 00:17:50,436 So they were able to, 430 00:17:50,436 --> 00:17:52,724 help me query like primary care clinicians 431 00:17:52,724 --> 00:17:54,140 within our health system. 432 00:17:54,373 --> 00:17:56,300 And that's interesting to kind of 433 00:17:56,300 --> 00:17:58,577 there's all these different categories 434 00:17:58,577 --> 00:18:02,646 of how doctors are, labeled, I guess within the health 435 00:18:02,646 --> 00:18:03,249 system. 436 00:18:03,249 --> 00:18:05,655 And so they may be in family medicine 437 00:18:05,655 --> 00:18:07,086 or internal medicine. 438 00:18:07,086 --> 00:18:08,688 Some people are in different groups 439 00:18:08,688 --> 00:18:11,223 even though they see patients with hypertension. 440 00:18:11,223 --> 00:18:14,545 So it's also a way to potentially identify 441 00:18:14,545 --> 00:18:15,494 clinicians. 442 00:18:15,962 --> 00:18:19,542 I literally just put in a grant application a couple 443 00:18:19,542 --> 00:18:20,299 weeks ago, 444 00:18:21,167 --> 00:18:23,658 to engage, I'll be where I will be 445 00:18:23,658 --> 00:18:24,537 recruiting, 446 00:18:25,171 --> 00:18:27,568 black patients in the Detroit area 447 00:18:27,568 --> 00:18:28,908 with hypertension, 448 00:18:28,908 --> 00:18:31,594 but I'm going to be focusing on federally qualified health 449 00:18:31,594 --> 00:18:32,011 centers. 450 00:18:32,345 --> 00:18:35,316 So Wayne State does not have and it's it's 451 00:18:35,316 --> 00:18:38,217 not connected to a health system per se. 452 00:18:38,484 --> 00:18:40,086 So I'm working with Independ. 453 00:18:40,086 --> 00:18:40,586 I will be 454 00:18:40,586 --> 00:18:42,561 working is funded with that, independent 455 00:18:42,561 --> 00:18:44,290 federally qualified health center. 456 00:18:44,557 --> 00:18:47,107 And the clinical director, you know, I talked to him 457 00:18:47,107 --> 00:18:47,793 several times 458 00:18:48,094 --> 00:18:48,661 and I said, no. 459 00:18:48,661 --> 00:18:51,868 Is there a way for me to work with your 80% and get a 460 00:18:51,868 --> 00:18:52,231 list? 461 00:18:52,465 --> 00:18:54,767 They said, we are not giving you list of our patients. 462 00:18:54,767 --> 00:18:56,789 But what they have found historically 463 00:18:56,789 --> 00:18:58,537 is that if their own clinicians 464 00:18:58,537 --> 00:19:00,242 bring up trials to their patients 465 00:19:00,242 --> 00:19:02,308 because this is a medically underserved 466 00:19:02,642 --> 00:19:04,577 group, they trust the doctors. 467 00:19:04,577 --> 00:19:06,734 So he said, if you get funded, our 468 00:19:06,734 --> 00:19:07,813 clinicians will, 469 00:19:08,881 --> 00:19:10,182 bring up the study 470 00:19:10,182 --> 00:19:13,185 and do a soft handoff if patients are interested. 471 00:19:13,786 --> 00:19:15,988 He suggested that I create like three by five 472 00:19:15,988 --> 00:19:17,698 cards are really kind of very simple, 473 00:19:17,698 --> 00:19:19,592 plain language description of the study. 474 00:19:19,792 --> 00:19:21,727 And if patients are interested, they'll give a flier 475 00:19:21,727 --> 00:19:23,029 and they will have to contact us. 476 00:19:23,029 --> 00:19:25,741 So my point here is you really have to just work 477 00:19:25,741 --> 00:19:26,532 with whoever, 478 00:19:27,333 --> 00:19:28,667 whatever group you're working with. 479 00:19:28,667 --> 00:19:30,428 And sometimes, like the methodology 480 00:19:30,428 --> 00:19:32,038 is really going to be dependent 481 00:19:32,038 --> 00:19:34,306 on where you are and who you want to work with 482 00:19:34,306 --> 00:19:36,621 and their comfort with kind of the different 483 00:19:36,621 --> 00:19:37,410 methodologies. 484 00:19:37,410 --> 00:19:40,413 So we'll see how that goes. 485 00:19:40,946 --> 00:19:41,247 All right. 486 00:19:41,247 --> 00:19:43,339 So now I want to talk a little bit 487 00:19:43,339 --> 00:19:45,985 about some health literacy considerations, 488 00:19:46,385 --> 00:19:48,773 both for clinical trial communications 489 00:19:48,773 --> 00:19:50,156 and informed consent. 490 00:19:51,691 --> 00:19:53,259 So there through the years 491 00:19:53,259 --> 00:19:57,063 there's been, different definitions of health literacy. 492 00:19:57,329 --> 00:20:00,366 I'm using one from Healthy people 2030. 493 00:20:00,366 --> 00:20:02,875 And they define personal health literacy 494 00:20:02,875 --> 00:20:05,071 as the degree to which individuals 495 00:20:05,071 --> 00:20:07,963 have the ability to find, understand, 496 00:20:07,963 --> 00:20:10,543 and use information and services 497 00:20:10,543 --> 00:20:12,594 to inform health related decisions 498 00:20:12,594 --> 00:20:14,947 and actions for themselves and others. 499 00:20:15,214 --> 00:20:17,635 So when you think about that, kind of like 500 00:20:17,635 --> 00:20:19,652 with our case, with Linda earlier, 501 00:20:19,652 --> 00:20:22,860 with you trying to find a, trial for type 502 00:20:22,860 --> 00:20:23,956 two diabetes, 503 00:20:25,024 --> 00:20:28,056 people differ in, you know, where they would find 504 00:20:28,056 --> 00:20:28,861 information, 505 00:20:28,861 --> 00:20:30,600 how they think about information, 506 00:20:30,600 --> 00:20:31,864 how they understand it, 507 00:20:32,164 --> 00:20:34,800 whether they prefer print or audio 508 00:20:34,800 --> 00:20:37,803 for more visual information. 509 00:20:38,003 --> 00:20:41,707 And, these are some examples of prior 510 00:20:41,707 --> 00:20:44,210 studies that have looked 511 00:20:44,210 --> 00:20:46,514 at the association between clinical trial 512 00:20:46,514 --> 00:20:48,481 participation and health literacy. 513 00:20:48,781 --> 00:20:51,450 So in this first study, anatomy spend too much time. 514 00:20:51,450 --> 00:20:54,126 But, this was a qualitative study 515 00:20:54,126 --> 00:20:57,289 of 20 women with lower health literacy 516 00:20:57,523 --> 00:21:00,326 who were, in who participated 517 00:21:00,326 --> 00:21:02,540 in a phase two trial for early stage 518 00:21:02,540 --> 00:21:03,462 breast cancer. 519 00:21:03,462 --> 00:21:05,564 And what they found was that, 520 00:21:06,632 --> 00:21:07,032 women 521 00:21:07,032 --> 00:21:09,635 with lower literacy were more likely to 522 00:21:09,635 --> 00:21:10,102 report 523 00:21:10,102 --> 00:21:12,202 that they relied on their provider 524 00:21:12,202 --> 00:21:14,240 recommendation on whether or not 525 00:21:14,240 --> 00:21:18,276 they should enroll in a trial, which probably is not, that 526 00:21:18,276 --> 00:21:19,111 surprising. 527 00:21:19,111 --> 00:21:21,869 So if you have trouble with health literacy, you may 528 00:21:21,869 --> 00:21:22,081 be, 529 00:21:22,448 --> 00:21:24,700 more heavily leaning on your clinical team 530 00:21:24,700 --> 00:21:25,451 to advise you 531 00:21:25,651 --> 00:21:28,510 on, you know, if you should maybe consider it 532 00:21:28,510 --> 00:21:28,954 or not 533 00:21:30,022 --> 00:21:32,158 in this, 534 00:21:32,158 --> 00:21:34,994 second study to the right, 535 00:21:34,994 --> 00:21:38,570 those colleagues that was a study of 500 cancer 536 00:21:38,570 --> 00:21:39,331 patients, 537 00:21:39,331 --> 00:21:41,001 and they were actually randomized 538 00:21:41,001 --> 00:21:42,368 to one of four conditions. 539 00:21:42,668 --> 00:21:45,905 So they either got information about randomization 540 00:21:45,905 --> 00:21:49,975 that was in plain language or given a gambling metaphor. 541 00:21:49,975 --> 00:21:53,112 And the gambling metaphor was like a flip of a coin. 542 00:21:53,112 --> 00:21:56,306 There was also what they called a benign metaphor, where they 543 00:21:56,306 --> 00:21:56,882 described, 544 00:21:57,883 --> 00:21:59,618 randomization as 545 00:21:59,618 --> 00:22:03,122 the chance of a pregnant woman having a male or a female child. 546 00:22:03,422 --> 00:22:06,392 And then there was this, control condition. 547 00:22:06,392 --> 00:22:08,327 And what they found was that people 548 00:22:08,327 --> 00:22:10,429 with higher health literacy actually, 549 00:22:11,030 --> 00:22:13,632 preferred, or did better understanding 550 00:22:13,632 --> 00:22:16,635 randomization with the gambling metaphor, 551 00:22:17,403 --> 00:22:20,321 again, the flip of a coin and then that for people with 552 00:22:20,321 --> 00:22:20,639 lower 553 00:22:20,639 --> 00:22:22,987 literacy skills were, actually understood 554 00:22:22,987 --> 00:22:24,877 randomization better when it was 555 00:22:24,877 --> 00:22:27,556 described as a chance of a pregnant woman 556 00:22:27,556 --> 00:22:29,582 having a male or female child. 557 00:22:30,282 --> 00:22:32,703 So again, this is just interesting studies 558 00:22:32,703 --> 00:22:34,086 and things to consider. 559 00:22:34,954 --> 00:22:38,494 And then finally, in this last study, 560 00:22:38,494 --> 00:22:40,025 by Kim and Kim, 561 00:22:40,025 --> 00:22:43,028 they, looked at the randomized 562 00:22:43,028 --> 00:22:46,532 150 people to get to one of two conditions. 563 00:22:46,832 --> 00:22:49,192 They either got a standard consent form 564 00:22:49,192 --> 00:22:50,402 with their calling, 565 00:22:50,402 --> 00:22:55,070 a standard consent form, or more simplified version of a consent 566 00:22:55,070 --> 00:22:55,507 form. 567 00:22:55,875 --> 00:22:57,843 And what they found is overall, 568 00:22:58,844 --> 00:22:59,812 regardless of your health 569 00:22:59,812 --> 00:23:02,380 literacy level, people prefer, 570 00:23:02,380 --> 00:23:03,749 simplification. 571 00:23:03,749 --> 00:23:05,651 And that was really better for everybody. 572 00:23:05,651 --> 00:23:07,810 Again, probably not a surprising finding 573 00:23:07,810 --> 00:23:09,321 if you have the opportunity 574 00:23:09,321 --> 00:23:12,691 to simplify information in a consent form. 575 00:23:12,691 --> 00:23:15,137 Sometimes they can be multiple pages 576 00:23:15,137 --> 00:23:16,495 and small font with 577 00:23:16,495 --> 00:23:19,003 lots of parts, for a lot of legal 578 00:23:19,003 --> 00:23:20,599 and ethical reasons. 579 00:23:20,599 --> 00:23:23,602 But, sometimes it can be very overwhelming. 580 00:23:25,037 --> 00:23:27,139 This, 581 00:23:27,139 --> 00:23:29,675 this, paper 582 00:23:29,675 --> 00:23:32,845 I had the privilege of working with colleagues, 583 00:23:32,845 --> 00:23:36,248 who are broadly in the decision science world. 584 00:23:36,448 --> 00:23:40,853 And, we published this paper really describing a process 585 00:23:40,853 --> 00:23:43,706 for developing a plain language decision 586 00:23:43,706 --> 00:23:44,990 support tool for, 587 00:23:45,257 --> 00:23:48,702 to help people consider participating in cancer clinical 588 00:23:48,702 --> 00:23:49,194 trials. 589 00:23:49,194 --> 00:23:51,225 And we looked at health literacy, 590 00:23:51,225 --> 00:23:53,132 really blending the merger of, 591 00:23:53,132 --> 00:23:55,676 like, health literacy, academic research 592 00:23:55,676 --> 00:23:57,903 and minority patient perspectives. 593 00:23:58,170 --> 00:24:02,308 So this was, like a three phase process. 594 00:24:02,308 --> 00:24:05,754 So in the first phase, we actually did qualitative 595 00:24:05,754 --> 00:24:06,512 interviews 596 00:24:06,512 --> 00:24:08,807 with 45 black and Hispanic cancer 597 00:24:08,807 --> 00:24:11,450 survivors to really understand their, 598 00:24:12,318 --> 00:24:15,788 challenges and opportunities related to clinical trials. 599 00:24:16,255 --> 00:24:21,126 The second part was a, in phase one was a survey of 1100, 600 00:24:22,394 --> 00:24:23,429 cancer survivors. 601 00:24:23,429 --> 00:24:25,331 And then there was a literature review. 602 00:24:25,331 --> 00:24:27,271 And then phase two was really content 603 00:24:27,271 --> 00:24:27,900 generation. 604 00:24:27,900 --> 00:24:29,803 So taking all of that information 605 00:24:29,803 --> 00:24:31,937 learned in phase one to create phase 606 00:24:31,937 --> 00:24:34,940 first prototype of this decision support tool. 607 00:24:35,207 --> 00:24:38,310 And then phase three was usability testing. 608 00:24:38,310 --> 00:24:40,933 And so this paper really just describes 609 00:24:40,933 --> 00:24:42,681 a process for developing, 610 00:24:43,549 --> 00:24:46,618 a decision support tool. 611 00:24:46,618 --> 00:24:49,621 And as part of that same paper, 612 00:24:49,822 --> 00:24:52,157 we proposed or talked 613 00:24:52,157 --> 00:24:55,194 about the Kasama role for cancer clinical trial. 614 00:24:55,194 --> 00:24:55,928 Participate. 615 00:24:55,928 --> 00:24:58,802 And that stands for knowledge empowerment and Values 616 00:24:58,802 --> 00:24:59,631 clarification. 617 00:24:59,631 --> 00:25:02,701 So I won't go over every box because some of these 618 00:25:02,701 --> 00:25:05,671 were, represented in past, 619 00:25:05,938 --> 00:25:06,538 models. 620 00:25:06,538 --> 00:25:10,576 But with decision support tools. 621 00:25:10,576 --> 00:25:12,595 It's really that those middle boxes, 622 00:25:12,595 --> 00:25:14,446 communication skills development 623 00:25:14,847 --> 00:25:17,606 and deliberate action is a really important and really 624 00:25:17,606 --> 00:25:18,117 important 625 00:25:18,450 --> 00:25:21,320 principles in decision making and 626 00:25:21,320 --> 00:25:24,590 also for, decision making and decision aids. 627 00:25:24,890 --> 00:25:26,792 The idea values clarification. 628 00:25:26,792 --> 00:25:29,098 So those are like exercises and questions 629 00:25:29,098 --> 00:25:30,729 to help people think through 630 00:25:31,130 --> 00:25:33,020 what their own personal values are 631 00:25:33,020 --> 00:25:34,633 and what they would perceive 632 00:25:34,633 --> 00:25:36,609 as like the value of participating 633 00:25:36,609 --> 00:25:38,237 in a cancer clinical trial. 634 00:25:40,773 --> 00:25:43,275 So now I just want to shift 635 00:25:43,275 --> 00:25:47,549 just a little bit to building and maintaining 636 00:25:47,549 --> 00:25:48,213 trust. 637 00:25:49,248 --> 00:25:52,518 And this is a quote, from a paper 638 00:25:52,885 --> 00:25:56,321 from my colleague Derek Griffith and colleagues. 639 00:25:56,321 --> 00:25:58,684 And I'm just going to read this out 640 00:25:58,684 --> 00:25:59,291 for you. 641 00:25:59,291 --> 00:26:03,638 Trust, mistrust and distrust influence people's ability to 642 00:26:03,638 --> 00:26:04,463 you trust, 643 00:26:04,463 --> 00:26:08,434 utilize critical resources and make decisions that are best 644 00:26:08,434 --> 00:26:10,068 for their health and well-being. 645 00:26:10,068 --> 00:26:12,871 Trust is necessary for optimizing health 646 00:26:12,871 --> 00:26:13,572 research, 647 00:26:13,572 --> 00:26:17,006 eliminating health health care disparities, and achieving 648 00:26:17,006 --> 00:26:17,910 health equity. 649 00:26:18,177 --> 00:26:20,425 But efforts to build trust to increase 650 00:26:20,425 --> 00:26:22,614 health care utilization and research 651 00:26:22,881 --> 00:26:25,484 participation may have little effort on 652 00:26:25,484 --> 00:26:26,151 attitudes 653 00:26:26,151 --> 00:26:29,182 or behaviors that are rooted and distrust and 654 00:26:29,182 --> 00:26:29,855 mistrust. 655 00:26:30,155 --> 00:26:32,672 And, this paper is not super long, 656 00:26:32,672 --> 00:26:34,893 but they do a really good job 657 00:26:34,893 --> 00:26:38,446 of talking about the concepts of trust, 658 00:26:38,446 --> 00:26:40,632 mistrust, and distrust. 659 00:26:40,632 --> 00:26:43,693 And sometimes in, academic situations 660 00:26:43,693 --> 00:26:44,603 like this, 661 00:26:44,603 --> 00:26:46,405 we use those terms interchangeably. 662 00:26:46,405 --> 00:26:49,717 But the roots of like, mistrust and distrust and even 663 00:26:49,717 --> 00:26:50,342 building, 664 00:26:51,677 --> 00:26:53,378 trust in people who have low trust. 665 00:26:53,378 --> 00:26:55,147 They're really distinct things. 666 00:26:55,147 --> 00:26:57,209 And they really argue that it's important 667 00:26:57,209 --> 00:26:58,517 that we're really precise 668 00:26:58,517 --> 00:27:01,443 about what we're talking about and what we're trying to 669 00:27:01,443 --> 00:27:02,187 intervene on. 670 00:27:04,923 --> 00:27:06,592 This paper, 671 00:27:06,592 --> 00:27:10,662 this is a conceptual model from a paper that Consuela 672 00:27:10,662 --> 00:27:13,832 Wilkins actually had published in 2018. 673 00:27:14,132 --> 00:27:17,445 And what I like about it is that it really focuses on 674 00:27:17,445 --> 00:27:18,070 enhancing 675 00:27:18,070 --> 00:27:20,348 trust in building effective partnerships 676 00:27:20,348 --> 00:27:22,741 with patients and community stakeholders. 677 00:27:23,242 --> 00:27:27,312 And on the left, these are, some of the trust dimensions 678 00:27:27,312 --> 00:27:30,310 and content areas that she posits that are really 679 00:27:30,310 --> 00:27:30,983 important. 680 00:27:31,917 --> 00:27:34,586 None of these should be surprising, but, 681 00:27:34,586 --> 00:27:36,054 I think it's good to, 682 00:27:37,022 --> 00:27:39,224 revisit concepts like it's important. 683 00:27:39,224 --> 00:27:41,757 Honesty is really important for building 684 00:27:41,757 --> 00:27:44,162 trust, communication and, confidence. 685 00:27:44,162 --> 00:27:47,277 So that's really the belief and reliability of all the different 686 00:27:47,277 --> 00:27:47,666 parties 687 00:27:48,033 --> 00:27:51,069 ensuring that people have, confidentiality 688 00:27:51,069 --> 00:27:54,573 that the teams are considered competent, 689 00:27:55,340 --> 00:27:57,717 that there's fairness and fidelity 690 00:27:57,717 --> 00:27:59,745 and safety and system trust. 691 00:27:59,745 --> 00:28:02,548 So the system trust really has to do 692 00:28:02,548 --> 00:28:04,883 with beliefs and institutions 693 00:28:04,883 --> 00:28:07,793 and processes and policies of the whole research 694 00:28:07,793 --> 00:28:08,520 enterprise. 695 00:28:08,921 --> 00:28:11,007 And then the right upper box talks 696 00:28:11,007 --> 00:28:12,357 about characteristics 697 00:28:12,357 --> 00:28:15,627 of trustworthy research researchers. 698 00:28:15,627 --> 00:28:18,523 So really trying to, as best we can be 699 00:28:18,523 --> 00:28:21,266 accessible, approachable, attentive 700 00:28:21,266 --> 00:28:24,002 to the needs and concerns of communities, 701 00:28:24,002 --> 00:28:26,672 empathetic, honest, humble, respectful. 702 00:28:26,972 --> 00:28:30,309 And then that bottom right box, 703 00:28:30,842 --> 00:28:33,981 really is, I think, supportive of some of the principles of 704 00:28:33,981 --> 00:28:34,513 community 705 00:28:34,513 --> 00:28:38,483 engaged research or principles like, cdpr, 706 00:28:38,850 --> 00:28:41,108 but that thinking about things like 707 00:28:41,108 --> 00:28:43,689 power dynamics and really transparency, 708 00:28:44,389 --> 00:28:48,393 how do you create infrastructure and policies to really, 709 00:28:48,660 --> 00:28:51,063 bolster up community stakeholders in the 710 00:28:51,063 --> 00:28:53,465 infrastructure for places that are like 711 00:28:53,465 --> 00:28:55,554 not the NIH Clinical Research Center 712 00:28:55,554 --> 00:28:57,469 or big academic medical centers? 713 00:28:58,170 --> 00:29:01,373 How are resources equally equitably distributed? 714 00:29:01,740 --> 00:29:04,128 Do we have, again, this idea of effective 715 00:29:04,128 --> 00:29:04,943 communication 716 00:29:05,777 --> 00:29:09,047 and really like establishing patterns of fulfilling trust? 717 00:29:09,781 --> 00:29:11,913 And also the notion of shared decision 718 00:29:11,913 --> 00:29:13,652 making among all the partners. 719 00:29:13,952 --> 00:29:16,955 And, really valuing, 720 00:29:17,356 --> 00:29:21,493 different resources and assets, such as lived experience. 721 00:29:21,493 --> 00:29:24,930 So I think not you all, but sometimes as research 722 00:29:25,564 --> 00:29:27,849 groups, we kind of come into communities 723 00:29:27,849 --> 00:29:29,334 or come into partnerships 724 00:29:29,701 --> 00:29:32,771 really, from a place of the information 725 00:29:32,771 --> 00:29:35,712 and resources that we can impart on the 726 00:29:35,712 --> 00:29:36,541 community. 727 00:29:36,541 --> 00:29:39,544 But community also has research, 728 00:29:40,112 --> 00:29:42,481 resources and experiences 729 00:29:42,481 --> 00:29:46,551 that are also equally valuable to the research, enterprise. 730 00:29:46,551 --> 00:29:47,319 I we should honor. 731 00:29:50,322 --> 00:29:53,325 I had, or I have the, 732 00:29:54,126 --> 00:29:56,469 benefit of working with a lot of different 733 00:29:56,469 --> 00:29:57,529 researchers, just, 734 00:29:57,896 --> 00:30:00,185 from where I've been, but also my own research 735 00:30:00,185 --> 00:30:00,732 interests. 736 00:30:00,732 --> 00:30:03,602 So Stacy Loeb is actually a urologist 737 00:30:03,602 --> 00:30:07,105 at NYU Health System and also with the Manhattan VA. 738 00:30:07,472 --> 00:30:10,442 And, she led a project that I was a part of 739 00:30:10,676 --> 00:30:13,679 that was really looking at, 740 00:30:13,679 --> 00:30:16,782 perceive trust in, 741 00:30:16,782 --> 00:30:19,084 online videos about prostate cancer. 742 00:30:19,084 --> 00:30:21,153 So this was a randomized clinical trial. 743 00:30:21,153 --> 00:30:22,688 We actually did this trial 744 00:30:22,688 --> 00:30:25,087 through, DiNardo, which used to be Survey 745 00:30:25,087 --> 00:30:26,491 Sampling International. 746 00:30:26,491 --> 00:30:29,100 So again, using an online survey panel 747 00:30:29,100 --> 00:30:30,062 and how this, 748 00:30:31,563 --> 00:30:34,966 clinical trial was set up where that, participants 749 00:30:35,434 --> 00:30:37,969 were randomized to one of four groups. 750 00:30:37,969 --> 00:30:40,697 So they either, saw a video about cancer 751 00:30:40,697 --> 00:30:42,674 screening or clinical trials 752 00:30:43,075 --> 00:30:46,278 that was presented by either a black physician, 753 00:30:46,645 --> 00:30:49,770 a black patient, a white physician, or a white 754 00:30:49,770 --> 00:30:50,382 patient. 755 00:30:50,615 --> 00:30:52,984 And then they took a questionnaire. 756 00:30:52,984 --> 00:30:56,142 And for this paper, our primary outcome was really 757 00:30:56,142 --> 00:30:56,521 trust 758 00:30:56,521 --> 00:30:58,256 in the information in the videos. 759 00:30:58,256 --> 00:31:02,160 And so we used a validated scale for trust that was called the 760 00:31:03,128 --> 00:31:03,962 group minority 761 00:31:03,962 --> 00:31:06,965 based Mistrust Scale by Haley Thompson. 762 00:31:07,466 --> 00:31:10,640 And really kind of the high point key 763 00:31:10,640 --> 00:31:14,072 finding was that in this clinical trial 764 00:31:14,072 --> 00:31:17,075 of over 2900 US men 765 00:31:17,075 --> 00:31:21,513 and women, black adults were statistically significantly 766 00:31:21,513 --> 00:31:24,933 more likely to trust videos with a black versus a white 767 00:31:24,933 --> 00:31:25,617 presenter. 768 00:31:25,617 --> 00:31:27,419 However, in white adults, 769 00:31:27,419 --> 00:31:30,343 the race of the presenter like was not associated with 770 00:31:30,343 --> 00:31:30,722 trust. 771 00:31:31,022 --> 00:31:33,414 And so I think a take home is from this, 772 00:31:33,414 --> 00:31:35,327 even though it was one setting, 773 00:31:35,327 --> 00:31:38,115 is that representation matters, diversity 774 00:31:38,115 --> 00:31:40,632 matters, not just on research teams, 775 00:31:40,632 --> 00:31:44,703 but in health communication and patient education materials. 776 00:31:46,538 --> 00:31:50,008 So my last few slides are really about points 777 00:31:50,008 --> 00:31:52,396 to consider when you're thinking of 778 00:31:52,396 --> 00:31:53,078 drafting, 779 00:31:53,779 --> 00:31:56,431 recruitment and retention plan for clinical 780 00:31:56,431 --> 00:31:57,048 research. 781 00:31:57,415 --> 00:32:02,454 And this information is from is a really nice, article 782 00:32:02,454 --> 00:32:05,194 that's posted on the National Institute 783 00:32:05,194 --> 00:32:07,092 of Mental Health, website. 784 00:32:07,092 --> 00:32:07,959 And the link is there. 785 00:32:07,959 --> 00:32:10,090 So the first key concept is community 786 00:32:10,090 --> 00:32:11,530 engagement and questions 787 00:32:11,530 --> 00:32:12,764 you can ask yourself. 788 00:32:12,764 --> 00:32:14,555 Although there's lots of questions 789 00:32:14,555 --> 00:32:15,767 in the actual document 790 00:32:15,767 --> 00:32:17,303 is, you know, have you identified 791 00:32:17,303 --> 00:32:19,304 communities that you would like to engage. 792 00:32:19,604 --> 00:32:21,712 So examples could be participants 793 00:32:21,712 --> 00:32:23,308 in their family members. 794 00:32:23,308 --> 00:32:26,311 If you're looking at something like Alzheimer's or like, 795 00:32:26,511 --> 00:32:29,548 Parkinson's support, or community centers, 796 00:32:29,815 --> 00:32:31,892 you also want to think through barriers 797 00:32:31,892 --> 00:32:32,851 to participation. 798 00:32:33,151 --> 00:32:36,121 So what are the barriers and how will you address them. 799 00:32:36,388 --> 00:32:38,190 And it could be things like time off 800 00:32:38,190 --> 00:32:39,391 work or transportation, 801 00:32:39,658 --> 00:32:42,594 or if it's a drug study or some kind of, 802 00:32:43,728 --> 00:32:45,572 change in how people will manage their health 803 00:32:45,572 --> 00:32:46,064 conditions. 804 00:32:46,064 --> 00:32:49,000 They may not want to change their medication plan. 805 00:32:49,000 --> 00:32:51,736 There's also benefits to participation. 806 00:32:51,736 --> 00:32:53,895 And this is really not what we think 807 00:32:53,895 --> 00:32:55,874 as researchers are the benefits. 808 00:32:55,874 --> 00:32:58,206 But what are the kind of perceived 809 00:32:58,206 --> 00:33:00,812 benefits from potential participants. 810 00:33:00,812 --> 00:33:03,422 And one thing that you could do is to work 811 00:33:03,422 --> 00:33:05,784 with communities through focus groups 812 00:33:05,784 --> 00:33:08,236 or interviews or surveys to get their, 813 00:33:08,236 --> 00:33:10,689 self-reported list of what they think 814 00:33:10,689 --> 00:33:13,987 are the potential benefits of whatever project you are 815 00:33:13,987 --> 00:33:14,659 proposing. 816 00:33:16,027 --> 00:33:18,496 They're also informational materials. 817 00:33:18,496 --> 00:33:20,811 So will the study materials account 818 00:33:20,811 --> 00:33:22,200 for different levels 819 00:33:22,200 --> 00:33:24,577 of literacy and cognitive abilities 820 00:33:24,577 --> 00:33:26,071 and suggestions here, 821 00:33:26,071 --> 00:33:27,993 as I mentioned earlier, to the rest, 822 00:33:27,993 --> 00:33:30,075 you can use clear and simple language. 823 00:33:30,542 --> 00:33:33,411 There's also the idea of planning and timeline. 824 00:33:33,411 --> 00:33:36,238 And so if you haven't done research yet, 825 00:33:36,238 --> 00:33:38,216 you know, like the timeline 826 00:33:38,216 --> 00:33:39,807 somehow always seems to be longer 827 00:33:39,807 --> 00:33:41,253 than what we initially think. 828 00:33:41,519 --> 00:33:44,222 So asking yourself as a story or asking yourself 829 00:33:44,222 --> 00:33:47,373 an experience researchers is just a realistic recruitment 830 00:33:47,373 --> 00:33:47,926 timeline. 831 00:33:48,193 --> 00:33:50,060 And then think about like if there are 832 00:33:50,060 --> 00:33:51,730 other local studies in your area, 833 00:33:52,497 --> 00:33:55,233 what are the estimates of eligible participants? 834 00:33:55,233 --> 00:33:58,703 But how successful or not were they in doing similar 835 00:33:58,703 --> 00:33:59,371 research? 836 00:33:59,938 --> 00:34:02,641 There's also the idea of recruitment strategies. 837 00:34:02,641 --> 00:34:04,462 So like what mechanisms will you use 838 00:34:04,462 --> 00:34:05,777 to encourage recruitment. 839 00:34:06,177 --> 00:34:07,829 And then make sure that all staff 840 00:34:07,829 --> 00:34:08,880 who communicate with 841 00:34:08,880 --> 00:34:12,050 potential participants receive proper training and 842 00:34:12,050 --> 00:34:12,684 practice. 843 00:34:14,052 --> 00:34:16,321 There's also retention strategies. 844 00:34:16,321 --> 00:34:18,356 So you want people to enroll, but if you 845 00:34:18,356 --> 00:34:20,392 have a multi month or multi year study, 846 00:34:20,759 --> 00:34:22,578 you want people to stay in the study 847 00:34:22,578 --> 00:34:24,195 to the end as much as possible. 848 00:34:24,396 --> 00:34:27,032 So how will you retain participants? 849 00:34:27,032 --> 00:34:29,089 How are you going to monitor retention 850 00:34:29,089 --> 00:34:30,335 if you have a problem? 851 00:34:30,902 --> 00:34:33,916 One of the ways it seems super simple is to be 852 00:34:33,916 --> 00:34:34,506 flexible 853 00:34:34,506 --> 00:34:36,107 with scheduling appointments. 854 00:34:36,107 --> 00:34:37,869 For example, not everybody can come 855 00:34:37,869 --> 00:34:39,077 to your research center 856 00:34:39,077 --> 00:34:42,080 on a Thursday between 12 and 4 p.m. 857 00:34:42,747 --> 00:34:44,683 get several phone numbers. 858 00:34:44,683 --> 00:34:47,125 So cell phone, home number if possible, 859 00:34:47,125 --> 00:34:49,754 or maybe, from family members and friends 860 00:34:49,754 --> 00:34:51,848 because sometimes people cell phones, 861 00:34:51,848 --> 00:34:54,225 you know, go dead or you can't find them. 862 00:34:54,225 --> 00:34:56,040 So it's good to have multiple phone 863 00:34:56,040 --> 00:34:58,063 numbers to follow up and then to send, 864 00:34:58,596 --> 00:35:01,066 participant small tokens of appreciation 865 00:35:01,066 --> 00:35:04,384 to remind them about your study, especially if it's not a one 866 00:35:04,384 --> 00:35:05,036 time thing. 867 00:35:07,072 --> 00:35:09,240 And then finally, 868 00:35:09,240 --> 00:35:11,899 when the study is over, how are you going to thank 869 00:35:11,899 --> 00:35:12,644 participants? 870 00:35:12,644 --> 00:35:15,647 Acknowledge acknowledge them for their time? 871 00:35:15,880 --> 00:35:17,812 How are you going to disseminate results 872 00:35:17,812 --> 00:35:19,551 to all of the communities involved? 873 00:35:19,951 --> 00:35:21,894 And how will you maintain relationships 874 00:35:21,894 --> 00:35:23,688 that you forged with the community? 875 00:35:23,688 --> 00:35:26,858 So like in my case, I hope I get funded for my, 876 00:35:27,826 --> 00:35:29,536 state intervention study with this 877 00:35:29,536 --> 00:35:31,296 federally qualified health clinic. 878 00:35:31,296 --> 00:35:34,299 So just put in good vibes and I will get fully funded. 879 00:35:34,299 --> 00:35:35,800 But after that, over. 880 00:35:35,800 --> 00:35:37,202 You don't want to be what they call 881 00:35:37,202 --> 00:35:38,203 a helicopter researcher. 882 00:35:38,203 --> 00:35:39,471 Just show up when you need something 883 00:35:39,471 --> 00:35:41,591 and then disappear and then come back ten years 884 00:35:41,591 --> 00:35:41,906 later. 885 00:35:41,906 --> 00:35:44,109 How will you manage that participation? 886 00:35:44,109 --> 00:35:46,111 That relationship. 887 00:35:46,111 --> 00:35:47,871 Send thank you notes to participants 888 00:35:47,871 --> 00:35:48,947 and other communities 889 00:35:48,947 --> 00:35:50,906 that were involved in your study, 890 00:35:50,906 --> 00:35:52,984 and then report results in formats 891 00:35:52,984 --> 00:35:55,481 that are most useful to the communities 892 00:35:55,481 --> 00:35:56,121 involved. 893 00:35:56,121 --> 00:35:59,190 So participants, family members of participants 894 00:35:59,190 --> 00:36:01,334 then also may be referring practice, 895 00:36:01,334 --> 00:36:03,061 practitioners or clinicians. 896 00:36:03,061 --> 00:36:05,699 So I found having worked in several health 897 00:36:05,699 --> 00:36:06,264 systems, 898 00:36:07,065 --> 00:36:09,567 the clinicians do not want long reports. 899 00:36:09,567 --> 00:36:12,504 A lot of times they like very short memos. 900 00:36:12,504 --> 00:36:14,339 Hopefully one page two page match. 901 00:36:14,339 --> 00:36:16,641 So trying to be as concise as possible. 902 00:36:18,443 --> 00:36:18,843 This is 903 00:36:18,843 --> 00:36:21,946 one example of appreciation for being in a clinical trial 904 00:36:21,946 --> 00:36:23,738 and going to talk in just a minute 905 00:36:23,738 --> 00:36:24,949 about my participation 906 00:36:25,216 --> 00:36:28,887 in the phase one clinical trial for the Pfizer Covid 19 vaccine. 907 00:36:29,554 --> 00:36:32,565 I was a participant and there was like 908 00:36:32,565 --> 00:36:34,626 14 visits over two years. 909 00:36:34,626 --> 00:36:37,762 But on my last study visit, even though we got paid 910 00:36:37,762 --> 00:36:39,754 for all of our time and all the visits, 911 00:36:39,754 --> 00:36:41,900 they gave us this little, like, gift box. 912 00:36:42,333 --> 00:36:45,003 And, so that's actually a pain. 913 00:36:45,003 --> 00:36:47,739 It's a little blurry, but it's a little gift box. 914 00:36:47,739 --> 00:36:50,308 And I opened the gift box. I was like, oh, this is so cool. 915 00:36:50,308 --> 00:36:51,810 I actually send it to our marketing 916 00:36:51,810 --> 00:36:54,813 and communications person who's actually my friend. 917 00:36:55,413 --> 00:36:56,448 In New York. 918 00:36:56,448 --> 00:36:58,708 But what they said was, for note in 919 00:36:58,708 --> 00:37:01,486 there was your your courage wrote history. 920 00:37:01,820 --> 00:37:05,512 Today, it's more clear than ever that our survival depends on one 921 00:37:05,512 --> 00:37:06,024 another. 922 00:37:06,324 --> 00:37:08,652 When you became a clinical trial volunteer 923 00:37:08,652 --> 00:37:09,761 for the first Covid 924 00:37:09,761 --> 00:37:12,764 19 vaccine to be approved, you joined 925 00:37:12,764 --> 00:37:15,718 tens of thousands to bring light to a darkened 926 00:37:15,718 --> 00:37:16,167 world. 927 00:37:16,401 --> 00:37:18,275 In honor of your pursuit of hope, 928 00:37:18,275 --> 00:37:19,637 we offer this keepsake. 929 00:37:19,637 --> 00:37:21,668 So it's a little pen, and in the back 930 00:37:21,668 --> 00:37:23,041 it said pursuit of Hope. 931 00:37:23,041 --> 00:37:24,743 And you could write your name in there. 932 00:37:24,743 --> 00:37:27,846 I thought I was probably feeling like extra, like 933 00:37:28,847 --> 00:37:30,832 citizen and Happy, but I was like, 934 00:37:30,832 --> 00:37:31,649 that was like 935 00:37:31,649 --> 00:37:35,037 just a really nice note that we we brought light to a darkened 936 00:37:35,037 --> 00:37:35,420 world. 937 00:37:36,354 --> 00:37:39,357 So anyway, that's just like one example. 938 00:37:39,624 --> 00:37:42,961 And again, I mentioned I was a participant 939 00:37:42,961 --> 00:37:45,548 in Pfizer's phase one, Covid vaccine 940 00:37:45,548 --> 00:37:46,698 clinical trial. 941 00:37:46,931 --> 00:37:49,934 I do not have any stocks or bonds in Pfizer, but, 942 00:37:50,368 --> 00:37:55,173 if you can see here that was, like our first, consent form 943 00:37:55,440 --> 00:37:58,120 and it was 20 pages and like ten point 944 00:37:58,120 --> 00:37:58,543 font, 945 00:37:59,310 --> 00:38:02,080 and I did actually read it all, but it was a lot. 946 00:38:02,080 --> 00:38:04,032 And because there were some minor changes 947 00:38:04,032 --> 00:38:05,984 throughout the study, I think I had like 948 00:38:05,984 --> 00:38:10,750 maybe 2 or 3, updates to the, consent 949 00:38:10,750 --> 00:38:11,523 form. 950 00:38:11,523 --> 00:38:14,935 And I learned a lot, and I'm happy to talk more about 951 00:38:14,935 --> 00:38:15,193 it. 952 00:38:15,560 --> 00:38:17,610 I wanted to be in the clinical trial 953 00:38:17,610 --> 00:38:18,863 for a lot of reasons. 954 00:38:19,130 --> 00:38:21,513 When I believe in vaccines and I was, I was kind of 955 00:38:21,513 --> 00:38:21,933 selfish. 956 00:38:21,933 --> 00:38:23,321 I was like, if if there's going to be a 957 00:38:23,321 --> 00:38:23,535 good, 958 00:38:24,602 --> 00:38:27,276 vaccine or an effective vaccine, I want to be one of the first to 959 00:38:27,276 --> 00:38:27,605 get it. 960 00:38:27,605 --> 00:38:30,742 So even the idea of, like, me knowing where to go to sign up 961 00:38:31,142 --> 00:38:33,278 had, you know, that, I guess with some level of 962 00:38:33,278 --> 00:38:33,778 privilege, 963 00:38:33,778 --> 00:38:35,880 because it wasn't quite obvious at the beginning. 964 00:38:35,880 --> 00:38:38,883 But I also had friends who got really sick from Covid. 965 00:38:39,617 --> 00:38:42,153 And I have the time, so I just wanted to contribute. 966 00:38:42,153 --> 00:38:44,833 But I also learned a lot, as a researcher 967 00:38:44,833 --> 00:38:46,925 who has done clinical research, 968 00:38:47,225 --> 00:38:49,961 being a participant and kind of going through 969 00:38:49,961 --> 00:38:53,097 all of those steps, it was very eye opening. 970 00:38:53,097 --> 00:38:55,099 I think I had a good, 971 00:38:55,099 --> 00:38:57,335 I personally had a good experience, 972 00:38:57,335 --> 00:38:59,571 but it's a lot, to do all of that. 973 00:38:59,571 --> 00:39:02,440 So I'm happy to talk about it. 974 00:39:02,440 --> 00:39:05,360 But as part of my own participation 975 00:39:05,360 --> 00:39:06,611 in the Pfizer, 976 00:39:07,111 --> 00:39:09,814 phase one study, and then also at that time 977 00:39:09,814 --> 00:39:13,651 doing a lot of clinical trials and education about the need 978 00:39:13,651 --> 00:39:18,022 for clinical trial participation for the safe, vaccine trials, 979 00:39:18,022 --> 00:39:22,594 but also after it was approved, talking a lot to communities 980 00:39:22,594 --> 00:39:25,563 about considering considering getting vaccinated. 981 00:39:25,563 --> 00:39:27,899 It actually informed, a line of research. 982 00:39:27,899 --> 00:39:28,933 So I actually, 983 00:39:29,968 --> 00:39:31,135 have another 984 00:39:31,135 --> 00:39:35,073 grant application under review about enhancing 985 00:39:35,807 --> 00:39:39,010 or reducing vaccine hesitancy for flu 986 00:39:39,010 --> 00:39:42,013 and Covid. 987 00:39:42,280 --> 00:39:43,147 Vaccines. 988 00:39:43,147 --> 00:39:47,350 And here this is really just, a simplified graph that, you 989 00:39:47,350 --> 00:39:48,219 know, there 990 00:39:48,219 --> 00:39:50,692 in terms of vaccine acceptance, there are 991 00:39:50,692 --> 00:39:52,924 some people who refuse all vaccines, 992 00:39:53,258 --> 00:39:55,284 some who refuse certain vaccines, 993 00:39:55,284 --> 00:39:57,862 some people who will just delay vaccines. 994 00:39:58,129 --> 00:40:01,332 You may accept vaccinations but have concerns. 995 00:40:01,332 --> 00:40:03,168 So like if you work for health system 996 00:40:03,168 --> 00:40:05,103 that requires the flu shot, you may be 997 00:40:05,103 --> 00:40:06,505 very concerned about the flu shot, 998 00:40:06,505 --> 00:40:07,372 but you may need to. 999 00:40:07,372 --> 00:40:09,841 You need to keep your job and pay your bills. 1000 00:40:09,841 --> 00:40:11,709 And you have people like me that you know, 1001 00:40:11,709 --> 00:40:13,444 there's a million things to be worried about. 1002 00:40:13,444 --> 00:40:15,280 I'm personally not worried about vaccines, 1003 00:40:15,280 --> 00:40:19,083 so I pretty much get all the age appropriate vaccines I can get. 1004 00:40:19,083 --> 00:40:22,086 But maybe I'm like a weird bird or whatever. 1005 00:40:22,487 --> 00:40:24,856 So my last example here, 1006 00:40:25,957 --> 00:40:27,825 this is a real study 1007 00:40:27,825 --> 00:40:31,996 of, looking at low pathogenic, tenacity 1008 00:40:31,996 --> 00:40:35,767 for avian, A10997 1009 00:40:35,767 --> 00:40:38,125 influenza virus in a healthy human 1010 00:40:38,125 --> 00:40:39,304 challenge model. 1011 00:40:39,604 --> 00:40:42,674 So, for those who are not familiar with, 1012 00:40:42,674 --> 00:40:45,995 human challenge trials, essentially what they're 1013 00:40:45,995 --> 00:40:46,411 doing 1014 00:40:46,411 --> 00:40:49,847 is purposely infecting people with the virus who are healthy. 1015 00:40:50,815 --> 00:40:53,084 And then I don't want to say to see what happens, but 1016 00:40:53,084 --> 00:40:56,487 looking at the immune response in those people. 1017 00:40:56,487 --> 00:40:58,318 So these folks have to be willing 1018 00:40:58,318 --> 00:41:00,591 to be infected with the virus, like flu. 1019 00:41:01,025 --> 00:41:05,029 And, this I think recruitment is actually wrapping up soon, 1020 00:41:05,430 --> 00:41:08,531 but this is a trial that's, being funded 1021 00:41:08,531 --> 00:41:10,702 and done right here at NIH. 1022 00:41:11,102 --> 00:41:14,869 If you, are interested, you can actually look at that QR 1023 00:41:14,869 --> 00:41:15,273 code. 1024 00:41:15,273 --> 00:41:18,443 I'm going to tell you what some of the requirements are. 1025 00:41:18,443 --> 00:41:21,446 So you have to be a healthy person 1026 00:41:21,679 --> 00:41:24,682 between 18 and 50. 1027 00:41:25,083 --> 00:41:27,968 You actually also, if you choose to do it, 1028 00:41:27,968 --> 00:41:29,754 you will get compensated. 1029 00:41:29,754 --> 00:41:32,444 But if you choose to do this human trial, 1030 00:41:32,444 --> 00:41:33,624 challenge, trial, 1031 00:41:34,392 --> 00:41:37,295 you actually have to do a prescreening call 1032 00:41:37,295 --> 00:41:40,344 and then you have to come to the NIH Clinical Center in 1033 00:41:40,344 --> 00:41:40,898 Bethesda. 1034 00:41:41,366 --> 00:41:45,436 And, you have to stay nine days in the inpatient hospital. 1035 00:41:46,337 --> 00:41:49,073 And then there's four outpatient follow up visits. 1036 00:41:49,073 --> 00:41:52,944 So eight, 18 and 59 days to be here 1037 00:41:52,944 --> 00:41:55,980 at NIH, in the hospital in four, because that's everybody. 1038 00:41:55,980 --> 00:41:59,029 So and you guys are in research, I'm sure you would sign up right 1039 00:41:59,029 --> 00:41:59,217 now 1040 00:41:59,217 --> 00:42:02,286 because you support the mission of NIH. 1041 00:42:02,286 --> 00:42:03,421 And this next, 1042 00:42:05,056 --> 00:42:06,638 slide, really just if you go to 1043 00:42:06,638 --> 00:42:07,658 clinicaltrials.gov, 1044 00:42:07,658 --> 00:42:09,093 this is where I pulled it from. 1045 00:42:09,093 --> 00:42:10,970 They get background about really the flu 1046 00:42:10,970 --> 00:42:12,096 and why it's important. 1047 00:42:12,363 --> 00:42:15,578 But what they're actually doing, they want to find the smallest 1048 00:42:15,578 --> 00:42:15,833 dose 1049 00:42:15,833 --> 00:42:19,871 of this influenza virus that may cause uncomplicated, 1050 00:42:19,871 --> 00:42:22,974 mild to moderate flu infection in healthy people. 1051 00:42:22,974 --> 00:42:25,977 And this dose will be used to inform, 1052 00:42:26,811 --> 00:42:30,982 how like the next flu viruses or flu vaccines will work. 1053 00:42:31,983 --> 00:42:34,544 If you were in charge of the recruitment 1054 00:42:34,544 --> 00:42:36,721 and retention plan for this human 1055 00:42:36,721 --> 00:42:39,390 challenge study, where we try to recruit 1056 00:42:39,390 --> 00:42:42,126 people again, they have to be 18 and 50. 1057 00:42:42,560 --> 00:42:44,976 They have to be willing to stay in the NIH 1058 00:42:44,976 --> 00:42:45,897 Clinical Center 1059 00:42:45,897 --> 00:42:48,598 hospital for nine days, and then come back 1060 00:42:48,598 --> 00:42:50,334 for four different visits. 1061 00:42:50,334 --> 00:42:51,836 They are compensated, 1062 00:42:51,836 --> 00:42:54,939 but the compensation amount was not on the website, 1063 00:42:54,939 --> 00:42:57,074 so I don't know how much they're actually compensating. 1064 00:42:57,074 --> 00:42:59,343 I don't know if I was in charge of recruitment and retention 1065 00:42:59,343 --> 00:43:01,312 where I have to go, because you essentially have 1066 00:43:01,312 --> 00:43:02,517 to have healthy people in the world 1067 00:43:02,517 --> 00:43:03,481 who are going to be willing 1068 00:43:03,481 --> 00:43:05,650 to be infected with the virus. 1069 00:43:05,650 --> 00:43:07,750 And it was interesting early on when, 1070 00:43:07,750 --> 00:43:09,454 like the first year of Covid, 1071 00:43:09,821 --> 00:43:12,526 the medical ethics group, where I was 1072 00:43:12,526 --> 00:43:15,159 before at NYU, they actually had us 1073 00:43:15,159 --> 00:43:19,134 symposium on should they have human challenge trials for 1074 00:43:19,134 --> 00:43:19,630 Covid? 1075 00:43:20,064 --> 00:43:22,452 And most people said no, because we have 1076 00:43:22,452 --> 00:43:24,602 no flight experience or mitigation. 1077 00:43:24,602 --> 00:43:27,271 But there were philosophical questions of 1078 00:43:27,271 --> 00:43:28,573 would it be ethical 1079 00:43:28,573 --> 00:43:31,576 during 2020 to infect people with Covid 1080 00:43:32,009 --> 00:43:35,413 19 to inform, treatment development? 1081 00:43:35,746 --> 00:43:37,325 It just thought that was an interesting 1082 00:43:37,325 --> 00:43:38,216 trial to think about.