Innovations in Clinical Investigation at Yale: Diversity, Access, and Equity

April 11, 2022

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00:00We're going to move from one area
00:02of innovation to another area and an
00:05area that the Yale Center for Clinical
00:08Investigation is developing or has really
00:11a very strong national reputation for
00:15leadership are in the areas of diversity,
00:18access and equity, and that is
00:21due in large part to the speakers.
00:24You're going to hear now.
00:27Tisha Johnson.
00:28Harris, the Chief operating officer.
00:30Or Yale for YCI Tisha's leadership here at
00:34Yale has been nothing short of extraordinary.
00:37Her commitment to this work,
00:38tireless and the outcome is,
00:41you'll see, is quite extraordinary.
00:44But this is work that you
00:45don't just do by yourself,
00:46and I'm really thrilled to also
00:49introduce someone who I've really
00:50enjoyed getting to know in my
00:52role as Co director of YC I.
00:54That's the Reverend Dr Leroy Perry
00:57and who is not only a.
01:00Leader and advocate for his
01:03congregation and and the African
01:05American community in Greater New Haven,
01:07but also.
01:10Innovator as a cultural ambassador
01:13for YCI and someone who has
01:16taught us an enormous amount
01:18here at Yale over the years.
01:20And so I'm thrilled to welcome
01:21you both up to present.
01:51OK.
01:54Thank you so much John.
01:55And if you all don't mind Speaking
01:58of commitment to research at Yale,
02:01our CTS, a progress report is due
02:02today and our training tables got
02:04kicked out earlier this morning.
02:06So I am going to be watching my
02:08phone to see if I need to hand
02:10over to John or Reverend Perry.
02:12But this is work that although Reverend
02:15Perry and I are standing here today,
02:18you want to come over and take more
02:20of a spotlight. Reverend Perry.
02:22This is work that has been
02:25really our entire center.
02:28Our entire community.
02:29The tireless work of the ambassadors and
02:32also the commitment of our leadership,
02:34not just John and our.
02:36Our Dean are wonderful Dean,
02:38but also the health system and the medical
02:40practice who have really committed.
02:42To the importance of clinical research as
02:45a potential care option for all of our
02:47patients and we are going to speak some.
02:50I'm not going to belabor the point.
02:52We all know that diversity and clinical
02:55trials is an issue that plagues us
02:57all we've heard so much about it as
03:00it relates specifically to COVID,
03:01but this is an issue that even though
03:04COVID has really shown a bright light here,
03:07these are issues that are very
03:09important because as we know,
03:11disease is disproportionately impacting
03:13the populations that are more marginalized.
03:16People of color and without research,
03:19this is never going to change,
03:20and so 12 years ago.
03:23That's what I said to Reverend Perry
03:25and his colleagues when they were
03:26sitting across the table looking at me
03:28with some really not so happy looks on
03:30their faces about partnering with Yale.
03:32And we had a long way to go
03:35and a lot of work to do.
03:36But it's not just about
03:38sharing the information,
03:39it's really I think,
03:40and what we have learned over the years
03:43is in order to fully address the access
03:45issues related to our clinical trials,
03:48we have to learn to do research
03:49in a different way,
03:50and I think that that's what the
03:53conversations with our patients and
03:54with our Community leaders have
03:56taught us is that it's not just about
03:59putting a fire up at the bus stop,
04:01it's about thinking about, you,
04:03know how many measures are you
04:05going to ask a patient?
04:07To complete,
04:08it's about how long your visits are.
04:10It's about transportation to the clinic.
04:13All of those things become important,
04:14and if we are really not addressing the
04:17protocol itself and partnering at the
04:19beginning of the scientific journey,
04:21it's impossible to expect that we're
04:22going to have a different outcome at the end.
04:25And I think that that's really
04:27what our work has been about.
04:29And it's really it's important to not
04:32only consider our scientific principles,
04:35but approaching our research from a
04:37very patient centric point of view and
04:40thinking about principles of fairness,
04:42of justice and really thinking
04:44about what's important to the
04:46individual in front of me.
04:48We just left a CC and I were both
04:49at the conference at the School
04:51of for the School of Public Health
04:53and Management this morning,
04:55and one of the patients with Lupus said
04:57she had participated in a clinical trial.
04:59Happily not at Yale in this case
05:02because what she said was the
05:04coordinator and the physician both who
05:06enrolled her in the clinical trial
05:08never actually looked her in the eye,
05:10and so halfway through the visit,
05:12she felt the need to reintroduce
05:14herself and say hi,
05:16my name is and and and to share
05:18that as a moment to actually get
05:20them to look at her to see her
05:22and not just to see a person who's
05:24signing an informed consent.
05:26And so I think that that's really
05:28what has changed the way we
05:30focus on clinical research here.
05:32And you know,
05:33I'm pleased to say that our research
05:35levels are number of trials are
05:37back at our pre COVID level.
05:39We actually never lost.
05:40Unlike a lot of other senators
05:42during COVID which had significant
05:44dips in the number of patients
05:46participated in in trials,
05:48we did not have that.
05:49We are seeing a little bit of a dip
05:50in the number of investigators who
05:52are doing clinical research right now.
05:54I think that's due to a lot
05:55of fatigue and other issues,
05:57but it's something that we want to watch.
05:59But as we start to think about where
06:01our clinical research it's going,
06:03I'm really proud to say that we've
06:05had such a patient centric focus as
06:07we really expand and think about the
06:10work across our delivery network.
06:12And Reverend Perry actually asked
06:13me to go through the slides and
06:15he was going to speak at the end,
06:16so I don't want you to think that
06:19I'm totally ignoring my Co presenter.
06:21This is a map and I I love this map
06:23because I think one of the when we
06:25show this map of the health system,
06:27we don't typically add our partners.
06:29But we have.
06:30And so when you look at it,
06:31it's actually interesting to see
06:33the concentration of our practice
06:35locations and the locations of the
06:36AME Zion churches and some of our
06:39other community partnerships because
06:40that actually is a way for us to
06:43think about accessing patients and
06:44our our communities and partnering
06:46in a way that not only really
06:48understands the attributes that we have.
06:51To bring from a clinical research
06:53perspective,
06:53but also the positive aspects that
06:55the Community brings when they are
06:57truly engaged in the science that
06:59we're doing.
07:00And one of the interesting things
07:02is our population here in our
07:04catchment area actually really
07:05closely mirrors the US population.
07:07We use a lot of technology to help
07:09us through this journey,
07:10and this is not meant to be read.
07:12But the important thing about the
07:13technology is I think everyone
07:15starts to think about these areas
07:17of decentralized trials and AI and
07:19all of these other things that are
07:20going to make. Research magically happened,
07:23and without we've seen it in COVID as
07:27Harry indicated in his talk that just
07:29because you have an incredible tool at
07:32your disposal that can change the course
07:35of a disease does not mean that it will
07:37be adopted without the partnership.
07:39Without the work, the hard work,
07:41and I think too often as it relates
07:43to our own clinical trials,
07:45the way we had thought about our
07:47approach to clinical research is the
07:49typical NIH and industry model where.
07:52The engagement is related to a
07:54specific molecule or a specific trial.
07:56When what has really changed the way
07:58they were able to partner with the
08:01community as a sustained commitment
08:03that is not disease specific and
08:05not trial specific and has enabled
08:07us to really transform how we think
08:10about our clinical research.
08:12And we've been at this for more
08:13than a decade now.
08:14We actually were thankful that we didn't
08:17host the Super Spreader event with
08:19the FDA prior to COVID in February.
08:22But this was,
08:23I think our last big conference was
08:25actually to celebrate with the FDA
08:27office of Minority Health and and
08:29HealthEquity the 10 year anniversary
08:31of our program and of their program
08:33and the two year anniversary of
08:35our collaboration with the FDA,
08:37which I'm going to speak about in a moment.
08:39But by far I think the thing that
08:41has changed our diversity statistics
08:43most at Yale.
08:45And when we started this partnership,
08:47the best data that we could find at the time,
08:49which was completely imperfect
08:51because we didn't track.
08:52Our participants in clinical trials,
08:54and so we had to look at NIH tables and
08:56IRB reporting and other kinds of things,
08:59but at best we could tell at the time
09:01we had about 2 to 4% participation
09:03by individuals who identified as
09:05a person of color,
09:07and now when we look back at
09:10last year's data,
09:11we had 31% across that banner year
09:13of recruitment that you saw that
09:15were participants who identified
09:17as a person of color and that work
09:19would not have happened without
09:21this man standing here.
09:22Or the partnerships that we have in
09:25the Community because I think the
09:27messaging and the strategies that they
09:29have helped to implement with a lot
09:31of hard work on their part to gain
09:33the knowledge from all of you from
09:35all of the research partners to talk about.
09:38What is a clinical trial?
09:39Let's talk honestly about things
09:42like Tuskegee and issues that really
09:45address go to the core of trust.
09:48And also I think the one of the
09:50biggest things that they've
09:52done is not only listening to us
09:54and talking about these issues,
09:56but really helping us to
09:58listen better to the community.
10:01And one of the areas that I think has
10:03been most compelling is to talk to
10:05the Community about disease disparity.
10:07It's interesting,
10:08as we've been partnered with
10:10the Cultural Ambassadors.
10:11How many individuals in the community
10:14don't really understand disease
10:16disparity in this way?
10:18One of the other really interesting things.
10:22Doctor Greenberg spoke about innovation.
10:24This is we we when we first started COVID,
10:28and that's me.
10:29I would have dressed up a little bit.
10:31Or had I known that this picture would
10:33live forever with Madeline and the IRB?
10:35But we were one of the first centers
10:38we wanted to launch a clinical study
10:40where a waiver of consent was required.
10:42In that case, an FDA meeting is
10:44required to inform the public.
10:45We weren't sure how we were going to
10:47do this in a in a post COVID state.
10:49And so we called Reverend Perry
10:51and Reverend Clayton and they said,
10:53oh we'll do it on the Ficklin show,
10:55so we did it on a radio show on Facebook
10:58live and we literally had 400 people
11:00show up to talk about a waiver of consent.
11:03It's it's a sound machine and the
11:05FDA has been so impressed with this.
11:07But the way to think about these
11:09innovations in the space that we
11:11never thought that we would do this,
11:13we thought that the way to have
11:14these Community meetings were these
11:16small informal town halls.
11:17And I can tell you throughout my
11:19career I have never had more than
11:2125 people or 30 people show up
11:23for a waiver of consent meeting to
11:25talk about a specific study.
11:26But the ambassadors have been great,
11:29partnering with us throughout
11:31COVID and before,
11:32and actually they launched their
11:34partnership with the radio show to talk
11:36about and have hosted many of our faculty,
11:38including John,
11:40including the Dean.
11:42Tony is actually done some work to
11:45to help train our our interns and
11:48so really trying to make sure that
11:50while we were we couldn't recruit
11:52in the same way and do things in
11:54the same way that we had innovative
11:56approaches to getting our information
11:58out into the community that we are
12:01trying to desperately to impact.
12:04And that also extended to helping
12:06us think about areas in the wake
12:08of not just the participation in
12:10the clinical trials but.
12:12Post approval,
12:13vaccine uptake and other things and.
12:17One of the most important things
12:19I think about our partnership with
12:22the with the Community leaders
12:24is not driven by our faculty.
12:26I think that that's a big difference.
12:28Whenever we had taught to partner
12:30in the past, it was I have a grant.
12:32It's due tomorrow and I need
12:34a lot of support.
12:35And that's literally the story that
12:37the leaders from both the church and
12:40who just shared at our first meeting
12:42was their interaction with our faculty
12:44were very transactional and not always.
12:47Based on things that were important to them,
12:49so one of the things that we do and
12:51generally we do it at least once a year,
12:53but in 2019 we had a long list of
12:55things that everyone wanted to work on,
12:57and then we kind of looked at
12:58the list and said there's no way
13:00we're going to get through all
13:01of this, and so we reprioritized
13:03ourselves and then, during COVID,
13:06our community leaders reprioritized
13:08everything and they said we are really still
13:11excited about sickle cell about diabetes,
13:14about cardiovascular disease,
13:15but we need to focus on
13:17COVID in our community.
13:18And that's what we did with the
13:20exception of our FDA project,
13:22which I'm going to speak about.
13:23We're also proud that we've launched
13:25a partnership with Telemundo,
13:26so we're really thinking about other issues,
13:28language and cultural access issues are
13:30things that we really struggle with.
13:33I think sometimes as we're
13:35designing our research,
13:36how are we going to make this most relevant?
13:38And we had to think about
13:40it in multiple ways,
13:41but I think one of the really important
13:43things is this partnership is not just
13:46about the research anymore, it has been.
13:48They have been incredible.
13:49Partners for us.
13:50As we think about headed into COVID,
13:52one of the first things that in a town hall.
13:56With Marcella Nunez Smith,
13:58she mentioned the importance
13:59of flu vaccine that year,
14:01because we were worried
14:02about clinical capacity.
14:03And so the ambassadors went right
14:05to work with flu vaccine campaigns,
14:08and so they're actually
14:09doing flu vaccine now,
14:10and pediatric vaccines for COVID
14:12and so really making sure that
14:15people are thinking about their
14:17health but also thinking about what?
14:19We need as a health system to
14:21be successful and to be able
14:24to think about patients.
14:25We've had some really big
14:27wins in this partnership.
14:29We have been able to really think
14:31about designing our research better,
14:33and I think for all of the faculty
14:35who have been through design
14:36consults with the ambassadors,
14:37what they have said is.
14:39If they come at a point where they can
14:41still make changes to the protocol,
14:43their science is better,
14:44their recruitment is better and
14:46they've had some really big wins
14:48we've been able to do things
14:49like consider how we have our
14:52homeless individuals participate
14:53in research and access programs,
14:55and so we've had some really big
14:57fixes with the participation of
14:59the cultural ambassadors and
15:00our data has been incredible.
15:03We actually just looked at our
15:05data prior to COVID about 8% of
15:07our new patient volume was coming
15:08to Yale for the first time.
15:10Research participation we thought
15:11that with COVID that might
15:13have changed significantly.
15:15We just looked at last year's data
15:17and that 8% is still holding,
15:18meaning that the first time someone
15:20has an interaction literally becoming
15:22a patient in our health system,
15:24it is for a clinical research visit,
15:26which I think is quite impressive.
15:28We've grown our clinical research
15:30with an industry partnerships quite
15:33significantly over the same decade,
15:35and we really just look back at the
15:37past five years of participation
15:39by our cultural ambassadors.
15:40And even though I shared that number
15:43of our total participation last year,
15:46when you when we look back at
15:48studies where the ambassadors
15:49have been specifically engaged and
15:51deployed and working hard
15:53on behalf of the researcher and partnered
15:56with the researcher, that's about
15:58that 61% over the past five years,
16:00which is astonishing with as you can see,
16:03really high rates of retention.
16:05This this program has really
16:08been a national model. The FDA.
16:11Has said that they have.
16:13This is unique for them even with
16:15an office that has specifically
16:16focused on clinical trials,
16:18equity and diversity.
16:20Reinmiller Rojo specifically wanted the
16:22program called out in the MO U to be
16:25able to work directly with the community.
16:28It's also led to a grant that
16:30we have right now and I'm just
16:32going to speed up a little bit,
16:34but it's led to a grant that
16:35we have right now,
16:36and one of the interesting things
16:38that we've looked at in this.
16:39Looking at the partnership between what we
16:42do with the Community and and our a our EHR.
16:47Looking back at our COVID data set,
16:49it was really interesting to see
16:52that the cost per participant
16:55recruitment through our EH?
16:58There are with culturally optimized messages
17:00from our ambassadors was actually quite low.
17:04It's it's about $10 per
17:06recruited participant.
17:08About $15.00 if we look
17:09at minority participation,
17:10but in the studies where we spent in
17:13one case about $30,000 in social media
17:15ads because the sponsor could afford it,
17:18and that in that case per participant,
17:21we were around $100 per participant,
17:24150.
17:24If we normalize for looking
17:26at inclusion issues so.
17:28We know that these optimized messages,
17:30we know that these strategies are working
17:33and changing the face of research
17:34and and sometimes I think we also,
17:36as clinicians as researchers,
17:39think that populations,
17:41especially minority populations,
17:42are less interested in technology
17:44and that has not been the case.
17:46We've seen really interesting adoption rates.
17:49Actually we saw higher adoption rates
17:52initially with our populations of color.
17:55And our work has recently
17:57been highlighted by pharma.
17:58As one of the only academic
18:01centers with with.
18:03With this this model and also by
18:07Merck and MRCT and our ambassadors
18:09have also helped us think about
18:12our workforce issues and launched
18:14a brand new internship program.
18:17We have a partnership with Southern
18:18now that we're taking interns
18:20from southern that the ambassadors
18:21have been quite engaged,
18:22but we are very proud of.
18:25The launching of our high school program,
18:27which is intended to expose kids
18:29even younger to clinical research,
18:31and we've had incredible uptake.
18:33We were only supposed to have
18:34them for four weeks in the summer
18:36and they have been with us now.
18:38They don't want to leave,
18:39so they're continuing with the internship.
18:4230 of the 37 and we wanted to end
18:44very quickly with one video from a
18:46young ambassador and then Reverend
18:48Perry is going to make a few comments.
18:52My name is Dolly Black.
18:53I'm graduate from sending
18:55message university in Raleigh,
18:56NC and also a young investor entering.
19:08Since becoming young training,
19:09I've learned many things
19:11about myself, my community,
19:12and the importance of clinical trials.
19:15It's very important for young
19:16investors to be involved in
19:18clinical trials so that we can gain
19:20the same knowledge understanding
19:21of diversity in the Community
19:23and medications and treatments
19:24that we are not taking today.
19:28Don't get information that
19:29they need of for many reasons.
19:31It could be a lack of access.
19:34The lack of knowledge,
19:36lack of trust and medical field.
19:42My main reason for becoming
19:43the youngest was to bridge
19:45the gap between generations.
19:47I learned many things,
19:49went through many different trials
19:51myself in trainings on autism,
19:55heart disease, blood pressure and
19:57other underlying conditions that we
19:59suffer from in the minority community.
20:06One thing that really grabbed my
20:08attention is just becoming a young
20:09investor was the lack of understanding
20:12that we have as a black community has
20:15on a medication that we take and the
20:18treatments that follow the medications.
20:20So it's becoming a younger bassador a lot
20:23of my peers have definitely become more
20:26curious and interested in clinical trials.
20:29One lesson that I learned that I
20:30did not expect while participating
20:32in the clinical trial is that I
20:34myself have a sleeping disorder.
20:36And This is why it is so important for
20:38us to participate in clinical trials.
20:45My name is Sally Black and
20:47I'm a young young culture.
20:53Sorry. Charlie Black stole the show.
21:00And I know his mother is very, very happy.
21:07It's hard to follow Tisha. She is.
21:15She is our coach. Our rock.
21:19She came and. Pitched to the community.
21:24Participation with Yale.
21:26And the YCI program.
21:29And when she asked us as she said,
21:32we were a little skeptical to say the least.
21:36We didn't know what she was
21:38trying to recruit us for.
21:40Was it for the school?
21:41Was it for the pharmaceutical companies or
21:44was it as a Guinea pig or an experiment?
21:48And after spending a number of weeks or a
21:52couple of months with her and she broke down,
21:56what the issues really were.
21:58You see, when you're a minority,
22:00you don't really look at
22:01yourself as a minority.
22:03Until someone points you out as a minority.
22:06And when you look at the
22:08social determinants of health,
22:09you figure that I go through this every day,
22:11so this is normal for me.
22:13But it's not.
22:14And so when we met with Tisha and
22:16then we started to see the research as
22:19it related to the number of minority
22:22participation in clinical trials and
22:25what that meant for us for the future.
22:28For better health outcomes, we said yes,
22:32we we really need to look at this and
22:34partner with them and and that's a partner.
22:38I mean partner.
22:39I mean collaborative.
22:41We are able to sit down and meet with.
22:45Members of YC CI and say when
22:47we look at our community,
22:49here are some of the issues
22:51we need you to help us with.
22:53For example,
22:54we had a young lady we met on
22:57a trip who told us she was a.
22:59Sickle cell patient.
23:00But every time she went to the
23:02hospital to get medicine,
23:04they called her drug addict
23:06and didn't want to serve her.
23:08So Tisha was Tisha was right on it
23:12and helped us with this young lady
23:15get through this and to understand
23:16that this goes on and so the DNA of
23:19medical history for African Americans
23:21and Black and brown people is different
23:24than it is for other populations.
23:26That's that's just the facts.
23:28Whether it's you know
23:30the social determinants,
23:31whether it's you know access to care,
23:33whatever it is, it's there,
23:35it's visible and we saw it.
23:36And she said doing COVID
23:37more so than any other.
23:38Time.
23:39So as YC embassadors, here's some
23:43of the things that we were able to.
23:46Address.
23:49Doctor Kenneth Doctor Crenshaw
23:50came and met with our group,
23:52and he wanted some help with.
23:56Prostate cancer and so you know,
24:01a lot of African American men do not.
24:04Gotta check up.
24:06They don't like that thing.
24:08They called the digital exam.
24:13And so we had so Doctor Crenshaw said,
24:15it's so it's it's. It's it's.
24:17It's kills more African
24:18American men than you know,
24:19two times more so than their counterparts.
24:21What can we do so we met?
24:24And then we we helped him and
24:26helped ourselves by saying, look,
24:27this is some of the things we can do
24:29instead of focusing on the individual,
24:31let's focus on the family.
24:33Let's ask the the wife,
24:35the daughter, the sister,
24:37the auntie, the brother,
24:39and see we can't get them.
24:42To be our advocates for going in and getting
24:45this check up and being a part of this.
24:48During the pandemic, you know,
24:50we realize that you know you
24:53couldn't go to the hospital to get
24:55your if you were black or Latino.
24:57You had some hesitancy
24:59about getting the vaccine,
25:00and the Hendersons hesitancy could
25:02have had a lot to do with our
25:04experience going to the hospital.
25:06You know when black people
25:07go to the hospital,
25:08they're in the waiting
25:09room until in the morning.
25:10And so they don't want to go back.
25:12All they're treated disrespectfully,
25:14for many.
25:15And so you know,
25:17just being able to have Y CI
25:21help us bring mobile clinics to
25:24our community was tremendous,
25:26and the response was tremendous.
25:28Even in a place like Branford,
25:30we had over 100 people who came.
25:34When we realized that our seniors
25:37also suffered from not having
25:40access to Wi-Fi or the kind of
25:43information that would help with
25:45regards to them getting online,
25:47doing telemedicine, going on to zoom,
25:50why CSYNC?
25:51I sponsored a project a pilot project
25:55where we had 15 senior citizens.
25:59In their 90s,
26:00some of them who came out for
26:03like 4 weeks to learn how they
26:05can reach their doctor online,
26:07how they could go to ICI and
26:09and look for clinical trials,
26:11how they could learn how to use zoom
26:14so it's just been phenomenal and also
26:17phenomenal I would say is that the Dean,
26:20when she was writing the.
26:23Mission statement for the Med
26:25school reached out to us.
26:27Asked us for input.
26:29And that that that that
26:32showed that the school cared.
26:33And I think what the community really
26:36wants to know is that that is not
26:38that that we're not necessarily the subject,
26:41but we're together,
26:43it's us working together for the betterment
26:46of healthcare and better health outcomes.
26:49Now Tisha knows me,
26:51I could stand here all day.
26:53So I had to look at her because I I know,
26:55you know, my time is up,
26:57but let me just say this.
26:58So for 2022,
27:00what we're looking at is autism advocacy.
27:05Coping with Alzheimer's disease.
27:08Affective alcoholism on mitochondria.
27:10One heart initiative and.
27:15Diversity.
27:17And a model of stroke education.
27:19And then we just targeted this,
27:21and I we've already divided into
27:22groups we've already met with people,
27:24and so we're all we're moving
27:27because we know that we it's it's.
27:29You know we we got to start the work early.
27:32If we're going to complete it.
27:38I just I just wanted to end with
27:41of the nine of the nine seniors
27:44who attended his workshop.
27:45Seven of them signed up for clinical trials.