2020 NMQF Summit on Health Disparities: Minority Representation in Clinical Trials

All right good morning good afternoon and good evening good people my name is raven miller i’m a senior marketing director with medtronic and i will be the moderator for today’s town hall which is going to be focused on minority representation and clinical trials we have an exciting program planned for you

Which is sponsored by the national urban league as well as the divine nine i am a proud member of delta sigma theta sorority incorporated and i am excited to share with you insights perspective and contributions from my fellow d9 brothers and sisters during today’s panel you’ll hear not only the current

State of ethnic minority enrollment in clinical trials but also strategies and insights on how we can improve enrollment and experience of minorities as they enroll in clinical trials so i hope you are ready for an engaging and enthusiastic conversation for the next couple of hours and with

That we’re going to watch a video before we hand it over to opening remarks from marc morial ceo and president of the national urban league dr gary puckering of you all know president and founder of the national minority quality forum as well as congresswoman robin kelly thank you all so much

All right so you ready on your mark i’m mark morial and i’m president of the national urban league but i am also a proud member of alpha phi alpha fraternity kovid is hurting black america the number of deaths are disproportionate the number of cases are disproportionate our community needs

A safe and effective vaccine without a safe and effect an effective vaccine many more people will die unnecessarily without a safe and effective vaccine you and i or our parents or grandparents or loved ones can find themselves terribly sick and also face the severe consequences of this awful dreaded pandemic reason

And common sense suggests that for a vaccine to be effective on black people black people need to be part of the clinical trials process the clinical trials process is part of the development of all medicines in the united states and this vaccine is critically important so i say yes i’m raising my hand

To volunteer for the clinical trials and i hope you’ll do so also reason and common sense must be greater than fear and distrust the deans of the black medical schools many african-american medical experts are working hard to ensure that these clinical trial processes are safe for us and that ultimately

That any vaccine develop is effective on all people including black and brown people and other people of color hey thank you for listening to me today i’m mark l’oreal i’m president of the national urban league and i’m a proud member of alpha by alpha fraternity and next we’ll turn it over to opening

Remarks from dr gary puckerin good afternoon and evening to everyone and thank you raven for that um clinical trials are incredibly important for our community certainly they’re important for drug development and understanding both the safety and the efficacy of medications as they touch minority populations and historically the way the system is worked

Is that we were not in the clinical trials and it was in the clinical setting where safety and efficacy got determined uh and that was far too late because sometimes we got adverse reactions and sometimes medications that did not work as well in our population so it’s extraordinarily important uh that we

Participate in clinical trials and i know the history they all can say tuskegee backward and forward but the point is that was in the past um lots of things have changed since then through the work of folks like dorothy height you know uh who was part of uh

The belmont uh commission who looked at um clinical trials and so there would be all kinds of safety precautions put in place that make clinical trials um really uh safe for us to participate in uh because the learnings are really incredible what’s also not well appreciated about clinical trials

Is that clinical guidelines um those guidelines are written to help physicians understand how to treat patients uh with a particular disease those guidelines are written based on the clinical trials so if you’re not in the clinical trials you’re also not going to be well represented in the

Clinical guidelines uh and again uh what ends up happening because we’re not in the clinical guidelines it’s in this it’s in the clinical setting when the physician goes to treat you uh that we find out whether that medication is safe and efficacious for you but it goes even further

Because those clinical guidelines inform pay for performance uh what we do in this country we incentivize uh physicians and others uh to treat according to the guidelines and so if if we’re not in the clinical trials we’re not in the guidelines and physicians start to get paid for

Performing um that uh that with therapies that may or may not be absolutely safe indefications for us so clinical guidelines are uh sort of the foundation of our healthcare system uh it it is where the science um gets established and so it’s critically important now it’s not unusual to find that um uh

Populations have been excluded from clinical trials um uh in the early um up until the 1990s for example children um were not tested in clinical trials and congress came up with the pediatric exclusivity provision and it encouraged uh the treatment of the encourage clinical trials in children so that we would have labeling

Labeling is used by physicians to tell them how to use a medication and because children are smaller and their metabolism is different it was really important to have those um to have those um those tests done so we knew how to treat them it was also the often drug um here

We were not testing people with rare diseases we were not developing medications for rare diseases and congress passed the often drug act um and right now they’re probably about 790 um drugs that have come out for rare diseases about 58 of all of the all of the drugs that were tested in 2018

Are a consequence of the rare um the um often drug act the national minority quality forum would argue we need to start thinking about how we use that exclusivity provision to encourage diversity um in clinical trials um it’s a deeper conversation that we should have but the point is

There’s a history in which we’ve used legislation to incentivize to increase diversity uh in clinical trials because it is so very important and as america becomes more diverse becomes more important um that we have diversity in our trials so looking forward to this conversation tonight um it’s an important one it lays

To the foundation of how we’ll deal with disparities and all the issues that are concerning us uh so um listen carefully i think we’ve got a great panel here tonight and i think there’s a lot of great work ahead of us so thank you very much

Thank you dr pucker and always words of wisdom i can listen to you for hours now i’m going to turn it over to the honorable robin kelly thank you for being here tonight thank you so much raven good evening everybody i’m congresswoman robin kelly and i represent the second district of

Illinois in congress and serve as the chair of the congressional black caucus health brain trust let me start by saying thank you thank you thank you for joining us i’m so excited to join you and the nfqf tonight for this panel as a proud member of sigma gamma rho i know

The importance historically black sororities and fraternities and our membership play in the black community from volunteering in the community to registering people to vote to all the scholarships that we give out we play a pivotal role in spreading awareness and giving back to our communities as covet

19 has shown us politics impacts our health in ways that we often overlook in daily life but when the world is put on hold by a global pandemic and we see death rates among african-americans that are four and five times the white death rates in fact according to a study by

The brookings institute covet 19 is the third leading cause of death of african americans trailing behind only heart disease and cancer much of this can be attributed to the fact that large numbers of black americans live in states that have not expanded medicaid this is why we must remember we decide

Our health at the ballot box now our nation is undergoing a key step in the fight against covet 19 vaccine trials however as was said because of decades of disturbing mistreatment there is a rightful mistrust of the medical research community by african americans as a result we have very low

Participation rates and clinical trials despite the outsize impact of disease on our communities additionally we historically have low rates of uptake for vaccines specifically for the flu but also other vaccines more broadly these factors show us how critical it is to have this conversation on working to address this ingrained mistrust now more

Than ever every year i have the privilege to participate in and present during the nfqf annual summit and although we are virtual this year i’m glad to support the work of this organization that lifts up the voices and achievements of the best and the brightest minds on the

Front lines of minority health care so many of the panelists here with us tonight are doing the hard work of research and enrollment driving policy and working on the front lines to keep our communities healthy and safe as african americans we know why many of our family members and neighbors

Distrust the medical community in congress we are still fighting to win henrietta lacks the recognition she and her family deserve for immeasurable contributions her cells have made to science and our health but as dr puckerin said that is in the past so we need to move forward while our community

Rightfully has reason to be suspicious things are changing and we need them to to help us keep our us and our families healthy more and more physicians are focused on medical ethics and they are working to identify and address inherent biases in health care also the medical and scientific workforces are

Diversifying still too slow for my taste but progress is progress since those dark days new procedures and processes designed to protect people and their families have been implemented yes risk is inherent is an inherent part of our new and groundbreaking medical innovation but now as opposed to the

Past it’s inform risks not gross experimentation there are resources for patients to empower themselves and their families with information and knowledge to direct their own care plus there are now programs to assist with medical care and resulting side effects associated with the research vaccine you might be

Thinking why should i volunteer to be a guinea pig or a lab rat but to be frank if we aren’t part of the trials we aren’t part of the cures i recently spoke to a reporter who found that less than one percent of participants in phase one trials for two promising

Vaccines were african-american under nih and fda guidance a vaccine needs at least 30 000 americans to participate in phase 3 or the final phase to advance to market while the agency encourages vaccine makers to recruit a study population with over-representation of minorities there is no requirement to do so we can’t

Afford any blind spots without vaccines especially given covet 19’s disproportionate impact on our communities considering the huge amount of your federal tax dollars spent on these vaccines they need to benefit all americans covet might be top of mind but it’s only one disease that disproportionately claims the life of

African americans hiv maternal mortality gun violence heart disease claim more african americans than they should in fact african americans died higher rates from eight of the ten top killers of americans including coven which is our most pressing battle but there are so many other diseases and disorders that we need diverse clinical trial

Participation to defeat but it’s not just enrollment and clinical trials that will help us in overcoming these obstacles we must also expand the number of african-americans working in the medical and biomedical research fields if we have people who look like us talking to us in our communities who are

From our communities communicating the importance of our participation we can start to build trust in congress we have a bill called here this legislation has strong provisions to increase participation in research by african americans and provisions to recruit a new generation of black health care and research leaders i’m so

Encouraged to be able to contribute to and welcome our wonderful panel full of amazing black professionals who all contribute to the health and well-being of our community in their chosen field i hope this conversation in this conversation we can encourage our brothers and sisters of the divine nine

To learn more about black participation in clinical trials and serve as ambassadors to their work to encourage more people in our community to enroll in clinical trials and please remember if we aren’t part of the trials we are just part we are not part of the cure so

Thank you guys so much again it’s an honor to be with you and uh have a great panel all right thank you so much dr kelly i really appreciate it alright so with that we are ready to get onto the panel we are going to introduce everyone so

What i’m going to ask is that we go in our founding date order uh where we’ll introduce everyone how you talk uh share your name what company you’re with uh what d9 organization of course you represent and why you chose to give your time here today so about one minute for

Everyone and that means we are starting with alpha phi alpha which is dr ron bailey hi good afternoon i’m ron bailey i’m a proud member of alpha alpha thank you so much for inviting me in today’s program i’m currently the assistant dean for clinical education at ucla drew out here in los angeles

In my day job i’m actually the chief medical officer for the kidron hospital system and i’ve been um i’ll run a 72 bed inpatient hospital system uh with outpatient psychiatry and outpatient primary care we have a rehearsal grant for uh we run at fdac i’m looking forward to our today’s discussion

Thank you so much we’re now going to go over to 1908 jacqueline wilson good evening everyone and thank you for inviting me to be a part of this important panel i work for pfizer incorporated and i am a senior director and research clinician um and working in our

Drug development in terms of phase two phase three and phase four trials and because i work in that area i thought it was really good for me to be a part of this so you guys could see that there is someone that looks like you that work at

Pfizer and work and part of my responsibility is being a part of the design the execution and the interpretation of the studies monitoring the studies in terms of their safety along with our you know study positions i am a part of alpha kappa alpha sorority proudly and

The reason i’m here tonight is again because i want you to understand why i go to work every single day and that is to make breakthroughs and better medicines to be a part of that for someone whose family members have had to take medications and have experienced bad side effects as a result

Of medications i want to help educate people that it is important for us to participate it’s a decision you make on your own but if you have more information maybe it will help you make a better informed decision about clinical trials thank you thank you so much jacqueline all right

We’re going to go to the brothers who share my colors the crimson and cream right so let’s start with marion brooks hello everyone i’m marion brooks a life member of kappa alpha psi um also vice president and u.s country head of diversity and inclusion at novartis pharmaceuticals and i’m here today

Because i’m helping drive policy within our organization around increasing diversity in our clinical trials as well as across the former trade association for all biotech and pharmaceutical company i sit on one of the boards there as well so i’m really excited to be a part of this conversation i had a

Conversation last week with congresswoman sheila jackson lee on this exact same topic so really excited to hear from everyone and to share my perspective as well thank you so much marion appreciate it it was so so nice that we did it twice so we have another member of kappa who’s

Here on the phone uh bryant fields hi thank you uh brian fields i’m a senior director uh in the integrated evidence group at metadata solutions um i’m here today because uh i’m also sorry i’m also a board member actually at the new york urban league so

Thank you mark for opening it up in that regard um i’m here today uh having worked in the industry for for many years i’ve been very close to the data that’s pretty much where uh most of my experience has been and um while in my uh my day job per se my my

Role is to help commercialize uh our data asset which is the largest um clinical trial repository in the industry um increasingly what we’re doing is generating leadership so helping understand um the differences in um clinical trial participation uh and the racial the the differences among race

That come along with that and when i see that you know our ability to power uh those abstracts in those studies is sometimes limited by the numbers of patient of actual black patients in uh our repository it it’s certainly calls to action uh for me to be here today to

To help with the appeal to uh do what we can collectively to increase our representation thank you thanks brian i really appreciate you so now we’re going to go over to my brothers the men of omega psy and that is being represented tonight by joe briggs good evening everybody joe briggs here i

Am public policy council at the nfl players association at first blush that may seem to be odd on this panel where we’re talking about diversities and trials in clinical trials but what what you should know is that the nfl players association has pushed for one of the longest and largest clinical trials for

Athletes in the united states of america and some of the data from that has not only far-reaching implications across not only our sport but it’s sports across the board i was part of a team that helped put together that trial a clinical trial and not only the

Long-form studies that are coming out of the harvard medical school in addition to that we were one of the first major sports to come up with our covet protocols to come back and perform support this fall and uh though we’ve seen some minor setbacks this week and a

Shuffling of our sport some of the data that has been generated from our daily testing of our nfl athletes most of whom almost 80 percent of our league being african-american have been very helpful to us understanding exactly how not only covet affects african-american populations but also with the large bmi

Of most of our members of the national football league there’s also data there that also has far-reaching effects we’ve been sharing this information with all of the populations that we’ve come in contact with including governmental agencies and as a part of that work we’ve also started to understand how and

What role we may play in helping advocate for other people using not only the technology that’s available but availing themselves to clinical trials because of the need for more diversity in their spaces so thank you very much for this opportunity and um knew that was coming and i’m here for

All of it uh with that i’m excited to now introduce my sorority sister courtney fitzhugh hello thank you so much for inviting me i’m a proud member of delta sigma theta sorority incorporated i’m also alaska research clinical resource scholar with the national heart lung life institute

At nih and that means that i run clinical trials i’m a physician scientist and my research focuses on sickle cell disease so i work with a group of patients who’ve had a genetic disorder their whole life and are as adults are mistreated um frequently thought of as drug seekers and we’re

Working with them to enroll them on clinical trials we our trials involve bone marrow transplant um as a curative option for people with sickle cell disease so i’m here because i wanted to share my expertise um there’s a hundred thousand african-americans living in the united states with sickle cell disease

And millions around the world and we’re able to actually recruit even from other countries so i have a lot of experience enrolling uh people unrepresented minorities on the clinical trials so thank you all right thank you courtney looking forward to hearing you from youth later today uh

Dr john ansley is representing the blue family so come through friends afternoon everyone um happy to be here i’m john ansley a otolaryngologist ear nose and throat surgeon uh my practice involves uh doing a lot of clinical research and over the past 20 years we’ve been involved in probably 75 to 90 studies

Focusing on a wide breadth of ear nose and throat medicine but we also do allergy studies even food studies and so i’m excited to be here just to give some perspective from a frontline clinician in a private practice who actively tries to recruit minorities into my uh trials and fortunately given the demographics

Of my city we’ve been very successful in that thank you all right thank you so much and then uh zeta phi beta you are up if only ek thank you yes hi and thank you for saying my name correctly uh my name is iphoma ike i’m a

Proud member of zeta phi basis already incorporated um shout out to all of my source celebrating uh our centennial um and i’m trained as a social science researcher and behavior and also as a human and civil rights attorney and as a professor in africana studies

As well as political science um i i come to this space um to give some of the background in in many of the ways that some folks don’t want to focus on which is um why the behavior and or the relationship between our communities and the medical world

How that impacts the way that clinical trials are messaged to our communities um but hopefully using this time to also think of strategies that are data informed but people centered i am the founder of a social impact firm called pink cornrows and earlier this year we were one of the first black led

Organizations to release a study called covent while black and then we modified it and relaunched it in partnership with the national black justice coalition to do covent while black and queer and the reason why we did that was just to make sure that as we are talking about the african-american

Community that we are not uh lumping all of us as if we are a monolith there are very distinct ways that we need to communicate and engage with our communities based off of the many things that make us both both great and also vulnerable so happy to be a part of this

Conversation to talk about how we can align and put a movement that allows for people to not see medicine as a space that is trying to harm them but a space that needs them to ensure that we uh we actually stay healthy so thank you thank you really appreciate that and we

Are going now to the blue and gold tracy brown you are up good evening everybody i’m so excited to be here i am a proud member of sigma gamma rho shout out to my soror kelly and all my soarers out there i am the chief executive officer of the

American diabetes association which is the largest patient advocacy group representing uh all forms of diabetes i myself uh have been thriving with type 2 diabetes now for 17 years and uh this issue around clinical trials is so so very important when you think about diabetes in this country one out of two people

Uh are living with diabetes or pre-diabetes with a disproportionate number of those people being people of color and african americans people of color represent about 50 percent more likely to be living with diabetes than not uh and african americans dying at a rate of uh nearly two and a half times uh

That of uh white so this this topic is so important when you think about the fact that 80 to 90 of the clinical trials uh are not diverse and when you think about the medication the supplies the technology the equipment all the things that are

Needed to help us thrive and to stop us from dying are dependent upon the very need to have us participating in these trials so that is why i’m here a very very important topic um and again i’m thankful and grateful to be uh here with such a distinguished group of panelists

Thank you thank you thank you and last but certainly not least is dr ron cox excited to hear from you friend and tell us who you’re representing thank you very much raven hi my name is dr rouhan cox i’m a proud member of iota phi theta fraternity incorporated and

I’m so happy to be here amongst great colleagues great friends great amazing professionals who share the same important characteristic of thriving and working in the medical space and to dispel disparities um my company i kind of wear two hats at the current moment in time i am an industry

Alliance development manager for mother cancer center the only national cancer institute designated center in the state of florida and i also am the assistant director of business development for the university of south florida working closely with the university of south florida college of medicine and so i am an immunologist by train

And a research scientist but my main focus on the day-to-day is to work with companies to establish partnerships to be able to advance and propel cancer forward while also working with companies to advance technologies forward um specifically in the medical space that would lead to better treatments and better options for

Patients it’s amazing to be here because i see myself just like many of the other panelists as a representation of an advocate for our communities each and every time that i make a partnership in each and every time that i partner with medical organizations pharmaceutical companies biotech companies startups or

Large matrix or organizations i have the opportunity to build partnerships that take into account things like health disparities that take into account how clinical trials are built that take into account um exactly how when you work with an academic institution how research can be handled and i’m proud of

That and i’m proud to be able to contribute my thoughts on such a distinguished panel all right thank you ron so this is the chance where the audience gets a chance to participate we’re going to pull up a poll question here before we jump into the panel just to kind of level set

Where we are with the conversation and so if we want to go ahead and pull up the question here uh feel free to start participating in what year did congress pass the national institutes health revitalization act which required the agency to include more women and people

Of color in their research if you would go ahead and put your answer in and then hit submit give you a second here to read the answers all right let’s go ahead and close the poll and the answer to this is 1993 1993 so that 24 you are on it um and the

Reason why we want to pose this question was to let you all know we’ve been having this conversation about the need to diversify clinical trials for a very long time and so this is where i want to jump in with the panel a little bit and my first question is is this

What is the current representation of ethnic minorities in in clinical trials so maybe let’s start with euron um so you can talk about it from from your seat and then courtney we’d love to hear from you on this as well so ron we’ll start with you ron bailey

Because i’m going to move to a different city shortly uh this is the we we do this for the hospital typically it meant quite as well today but yeah our numbers generally are um well below uh fifteen twenty percent and almost over i didn’t say i mentioned earlier i’ve been psychiatry or

Psychiatrists typically in my basic training and we’ve actually had a lower numbers in addictions particularly that we’ve even seen i think in many other areas of organized medicine which has uh had remarkably uh average impact on us uh first and foremost uh i think gary buchmann said

If we’re not in the trials uh very often can extrapolate the data but i’ve also thought that the other pieces that we’re not into trials we actually don’t encourage more young african-american and other biblical researchers to participate i think in uh collecting information uh encouraging person to actually join trials and then

Actually thinking through i think the design of trial which often uh may not include some particular kind of concerns that are unique i think for our patient population so i think one of the huge challenges for us going forward is to actually educate and advocate for african-americans to be involved in

Every aspect of clinical trial process from uh initiation of the idea uh to development to recruitment to participation and they need to extrapolate on the data huge issues for us i think always in medicine particularly in psychiatry appreciate that courtney were your thoughts yeah so i mentioned earlier that i work

With patients who have sickle cell disease and so by definition the vast majority of my patients or the people that we enroll in clinical trials are african-american and we started doing bone marrow transplants at the nih in 2004 so initially when we didn’t have much experience it was challenging to

Recruit these patients and we started with the patients that were being followed at the nih the ones that knew us um that we had some kind of a relationship with uh but more recently um the transplants have been so successful that you know my mentor has

Been on 60 minutes he was interviewed on multiple um tv stations so now we actually have an overabundance of people trying to come to the night since we do have this opportunity to offer a cure on the outside it is more challenging especially when people are not enrolling

Um patients onto trials that involve cure and so they do have their the biggest issue even for us when we’re bringing people to the nih we still spend about one or two months trying to overcome that that trust barrier again because these patients are so mistreated

They’re at home um in so much pain and before they even go to the emergency room because of the way that they’re commonly treated so we spend the first couple of months really trying to build that that um that trust and we also um meet patients

Where they are we go to advocacy groups and we ask them what kinds of things are important to them as far as being enrolled in clinical trials so that’s how we’re able to and even pay for transportation which is a big um limitation for a lot of our patients so

That’s how we’ve been able to overcome and get people to enroll in our studies you know i appreciate that from from both angles um i do want to go back to something that eufauma mentioned earlier even during her conversation in her opening remarks which is there are some

Historical factors that we can’t ignore and so my question to you and to ruin is help us understand what factors may be driving low enrollment of ethnic minorities in these clinical trials um both from a patient perspective and then maybe even from an institutional perspective yeah

Yeah we’ll start with you from like the community perspective um and i don’t want to go as far back um you know to encapsulate um how we got to the practice of all areas of medicine including ob gyn basic family care all of them have are rooted in really really um

Uh depressing and oppressive practices um dating all the way back to enslavement but there are some recent studies that i think could be helpful in how we look at the factors that drive low turnout uh for communities um the first study is a a 1996 study that was

In the journal of the national medical association and it identified four major barriers to participation in that case it was a stroke uh prevention trial um the first one was lack of awareness about the trials we find that there typically is either an under messaging or poor messaging within communities of

Color communities of ethnic backgrounds and even if they are there they’re often not considerate of multiple languages um uh complicated language um or just the times at which they’re being advertised and the modes by which they’re advertised um the second uh factor that they found as a major barrier was economic very economic

Factors now pharmaceutical companies are getting better at providing trials and making sure that incidentals are also encompassed in how people can participate but at not even just within the last decade or so we have seen that individuals that have had to drive to a site or have had to use their

Own resources to participate uh tend to drop off even if they signed up to be a part of the the clinical trial um the the third factor that this study found was communication issues um which is similar to the lack of awareness of the trials um that even when people were

A part of the studies um keeping up with what the goings-ons of the studies were was was uh significantly different within our communities compared to say white counterparts who were also part of the trial and then of course finally mistrust which is still connected to um

Even a later study than that a 1998 study that also showed that individuals that were enrolled they dropped off because they felt that um they were being seen as guinea pigs the reason why this is really important um and guinea pigs is a quote that is not me

Categorizing it that is how our communities address the way their either participation or their lack thereof is being treated um so it’s not enough for us to say um the past doesn’t matter the reality is you don’t have trials without people and we must do a better job understanding where people

Are entering into the conversation and ensuring that we’re not insulting where they’re at but we’re using that as a way to support industries whether it’s pharmaceutical companies or those that serve as credible messengers within the community which we’ll talk about later how do we how do we solve for this um

But as of right now there are two distinct groups um one is for those that do stay in trials there’s a little bit of research that shows that they stay in it because they already know that they have a high risk of being either impacted by the the um ailment that’s

Being studied or their family is connected to that ailment but a significant number of us drop off because even when we participate we kind of have a little bit of a working feeling that maybe we’re being used and we drop off yes and i’ll i’ll go ahead and add on to

That and that was great i think that covered also some of the points that i was going to mention um amongst with the fear and the communication i’ll also add um in terms of the communication uh medicine and science is a very jargon field atmosphere so when you’re

Communicating to on a patient level to someone and you’re adding in all of these words that someone may not necessarily be able to relate to that creates an environment where someone does not feel attached to that particular study and so within that there’s a lot of um

Patients who don’t feel like they have a proper understanding of what they’re being explained and why this is particularly important and why they may fit into that along with the um that is the publicity of how uh instant individuals were mistreated in the past and so along with that publicity of how

Many individuals were mistreated in the past there’s also a lack of publicity in terms of how important it may be and so that um abundance of of information in terms of how things were done in the past versus the lack of information of how things

Could be how there could be it could be helpful for someone to participate then contributes to a culture where someone does not feel comfortable in terms of contributing and then finally i would like to say that a lot of minority communities rely heavily on the opinions of others close

To them whether it be a family member a mentor people of that sort and so when you have that information that is being passed down that may not necessarily um be of the best um view of clinical trials then that individual doesn’t feel like they want to go more so the safer

Route or more of a watchful waiting route rather than one that may contribute to the field um and add uh the diversity to the field and a lot of that and speaking on the in on the institution comes from the intentionality of the institution there seems to be a lack of intentionality on

A lot of institutions to make diversity something that is particularly important and their feet are not being held to the fire for that intentionality to take place you see with a lot of diseases such as cancer where age if you’re a certain age there has to be you know

Things that are taking place data that is recorded and now you see more demographic data being required for certain um rare disease trials and things of that nature but intentionality is one of the big things do they have clinical trial coordinators that can be able to explain to the patient when they’re consenting

Them you know exactly what is going on and how this may this may be particularly effective and then also does the study coordinator or the investigator that’s handling this trial at the institution do they care really about the diversity or do they care about meeting a patient accrual quota

That would then necessitate their results all of which contribute to the lack of biodiversity and why biodiversity may not be of the highest um priority excellent excellent jump in two if i can i wonder if there’s ever been a study that actually looked at the race of the principal investigator in terms of

Addressing issues like trust comfort level jogging and just familiarity again as i spoke about earlier i’ve done a bunch of clinical trials and i do think it matters that my african-american patients view me as someone they can trust and not someone who’s white who would do anything to them to that end

We are very selective in the trials that we choose to participate in just because we want them to feel that comfort that we would not put them in a trial that we would not put my kid in or my family members in and i think that’s an important issue

That when the sort of stakeholders and others are looking at sites to choose and select for studies need to look for investigators who look like the patients they hope to enroll i saw a lot of head nods going on so i think you uh maybe hit the a-man corner

With that answer uh john so i appreciate that so i want to actually have you build on this point i’m gonna probably ask jacqueline uh to jump in here as well um dr puckerin in his opening remarks started to um kind of allude to what is some of the

Potential impact of having low to no ethnic minorities enrolled in clinical trials and i’d love to hear from your perspective what you believe that is so jaclyn will start with you and then john will come over to you absolutely thank you again the decision to participate in a clinical trial is an

Individual’s decision that should be made with your family your friends and with your loved ones but what we found and if you look in the data from 2008 to um 2013 21 of the drugs that were approved on the market the fda noted later that there was a

Difference between the safety and the efficacy of these medications in african-americans and minorities and why is this and that is because of the demographics that is because we all are different in some kind of way in terms of our genetics in terms of our gender in terms of our our age other

Disease states comorbidities other medications we’re taking well how we metabolize drug how we eliminate a drug how that drug works in our system versus someone else’s system these are all important factors that have to be taken into consideration and if they’re not we find that we have

Drugs that make it to the market that may not work as well in someone as they work in another minority group or in another population for example ace inhibitors are widely used for the treatment of hypertension ace inhibitors now we know do not work as well and african americans however

There is a side effect known as angioedema which is a swelling that can occur in the face and the mouth and it can also occur in the thyroid it’s five times more likely to occur in african americans we didn’t know this because there weren’t enough african-americans that participated in the study and

We found out after patients in the clinical setting as someone said till we found out later and this has led to many of emergency room visits when they do have problems with the um when it happens in their third and their larnix is impacted with the angioedema

So this is one reason why we need to participate there’s also data that looks at in our breast cancer tamoxifen because of the low numbers in the original study these studies showed that african americans did not do as well on tamoxifen however later sub-study analysis shows that african-american and white women

That are er positive both do well with tamoxifen so it’s not just for others and i know there’s a lot of mistrust and i know we have to continue these dialogues and that’s why i’m glad we’re here today so that we can help people understand it’s not just for others it’s

Also for yourself because you don’t want a medicine to get to the market you take it because you have diabetes you have hypertension and then you react to either it doesn’t work as well for you or you experience a severe side effects so we are committed to doing a better

Job we know that we have a long way to go but advisor we are committed to having these conversations to doing a better job of trying to engage minority populations in our study so that we can make better drugs for everyone not just for a certain population

Thank you jacqueline john you want to add anything to that sure i think that was very well said and i think the take home point is that we are different in some ways metabolically we’re different and we find that in the way we metabolize the medicines and i’ll

Give a couple of examples as to jacqueline if you take codeine some africans african americans are hyper metabolizers of codeine because of different enzymes and the codeine gets turned into morphine and you run the risk of having an overdose and now codeine in pediatric patients now has a

Black box warning because of that as jacqueline said the hypertensive medicines um are one that’s known to react differently in african americans versus whites but also asthma medicines have the same issue in terms of how we handle the better blockers and the asthma medicines so it’s real important that when you’re

Studying these very common diseases like asthma hypertension pain medicine that we have a wide breadth of different minorities in these groups so that we can be prepared to know how the blacks or whites are going to metabolize them what are the potential side effects and how efficacious will it be such that we

Don’t get medicines on the market that won’t work in blacks but yet are getting repeatedly described prescribed with no real clear explanation as to why it’s not working i agree with similar cases in psychiatry yeah please go ahead and elaborate ron if i’m going to have very similar kids

To psychiatrists i’m a psychiatrist and was really shocked to find out um about a decade or so in my career that for so many african patients who have been disproportionately labeled and actually mistreated uh for being medication non-compliant we find out that the classic medications in psychiatry the d2 blocking agents that

Treat you know violent aggression and psychosis they’re often not metabolized via this cytochrome p450 2d6 system so the forward genetics are very different african-americans about a third of us can’t really metabolize those meds only about 68 percent of caucasians so we were being hostile toward black patients all throughout the literature that

Blacks are more non-compliant when we finally figured out the data partnered out very clearly that it was really our meds that were not terrible african-americans and the side effects were often causing them not to take them very similar point to the coding example and i appreciate you jumping in there

And if i could just clarify quickly when we talk about metabolize because everybody on the line is not in the science field we’re talking about the way your stomach breaks down your liver breaks down these drugs when we talk about the cytochrome p450 these are enzymes in our livers we all have them

But there are some genetic differences around the different cytochrome p450 but these are just what you just need to know that there’s enzymes in our livers and most of our drugs go through the liver to be broken down when we say metabolized they’re broken down and then they’re eliminated through the kidneys

There’s genetic variations between enzymes in the liver also there are differences in the way and we eliminate drugs through the kidneys and so again we have to make sure we understand the differences and we would rather understand during the clinical trials than when they get on the market

I appreciate that clarification i want to keep us moving forward here um and really talk about intersectionality right when you have race plus income race plus rural living race plus uh education level how does intersectionality play into potentially the enrollment or the lack of enrollment in clinical trials joe i’d love to hear

From you on this question as well as tracy so tracy we’ll start with you and then joe we’ll go to you yeah um raven uh thanks for the question so you know this this point of intersectionality uh it’s a cumulative effect right so you you just highlighted all of the

Combinations and there are many more combinations that lead to what has already been discussed the lack of awareness the mistrust the economic factors the communications all of that gets compounded uh when you actually start to think about intersectionality and as i think about it i try to as both a a patient myself

Helicopter all the way up and think about what we’re talking about when participating in in clinical trials is very much a behavior and when you start to think about behaviors at the base of that behavior is trust um and it you know like we can take the the the

Mistrust that exists with african americans and all of us on this line can probably give you the long lineage but even if you you take that out of the equation there was a few research study done recently that said 35 of people trust science period black white whatever that

Is not good so then you have to think about well what what are the the guiding factors and what we really see is people believe people who have common values and connection and so you know if you’re talking about changing behavior you have to talk about am i connecting

With the person and when we start talking about connections it’s basic do you see me do you hear me and do you understand me and if we can’t figure out how to get that right we’re not going to get the behavior change we’re not going to get

Past the mistrust so there’s some very basic things that we have to think about as it relates to getting more diversity in these clinical trials i think there’s three things we have to think about how do we rethink where we engage right community somebody said already that there’s a real cultural trend called

Distributed trust people trust their tribe they trust their family their friends their neighbors that’s a real cultural trend so we have to rethink where the research engages we have to retool how this actually happens there’s another cultural trend around frictionless behavior you have to make it simple and easy

And you have to make it snackable i have to be able to digest this so i think we have to retool how we actually make participating a bit more frictionless and then the final thing i’d say is we have to replace this notion of involvement with real

Connection she said a mouthful joe i know you’re going to add something to it though come through well i mean i’m going to try my best not to get in trouble but the the conversation earlier about the race and ethnicity of the principal investigators was just to scratch on the surface

There’s just so many ways that and to go and piggyback on what was just said about having an understanding of how to make this snackable and not more frictionless for the people who are participating we also have to make sure that the people are who are designing the studies who are the principal

Investigator who are coordinating the people getting in i need you to see me but i also need to see me in you and if everywhere that i go everybody that i talk to no one looks like me that’s never going to help me get over some of these humps that we’ve

Seen in some of these places these clinical trials that happen in a vacuum that is filled with people who i do not trust because they’re not from my community and they never look like me that does not seem inviting to someone so when we were designing uh and trying

To come up with ways to create some of our player studies initially that was the way that some of the other folks thought that they should design the traditional way we find our principal investigator who looks like a certain way and they have certain credentials and they would have

Coordinators that they’ve worked with in the past and they all have a history of working well together on these things these players didn’t care nothing about that they wanted to find someone who looked like them uh that they can talk to that could be a validator of why i

Even needed to return the phone call to even get started down the pathway of even getting to become a part of the study so unless you are going to also talk about how we increase the diversity on the other side of the table and make sure that that’s also included in the

Way these things are marketed the way these things are talked about the way that we normalize how these things are also a part of our community and and and make it that seamless that frictionless i love that word that my sister just used it until we get to that point

We will continue to see the lowered numbers and the intersectionality will continue to be a lost opportunity uh for us to find ways to better treat our communities so so one of the things that i hope to bring to this conversation is some of the things that we did we

Brought in and invited in people who looked like us to also have not only business relationships with some of the hospitals that we were working with but we also included some requirements on those places to make sure that they also included folks that looked like the

People that they were studying as a part of the team that was working with them and onboarding them and making sure that they felt comfortable as they continued to move through the process unless we do more of that unless we place more demands on the people who are actually

Coordinating these studies to do that then i think they were going to lose more opportunities to not only find cures but find ways to help our people be better and that too is a part of the mission of all of this raven can can i just add something very quickly

Yes please do this is this is uh when i hear intersectionality i’m like where’s the papyrus leaf i got so much to say um so one of the things that i like to say is that um representation is important there’s a lot of studies around the behavior and communication and how we

Connect with each other just from seeing somebody that looks like us right um i also want to urge us to to ponder with what it means for a representation not to to be not for representation is not enough right it is important and we also need to recognize that while we are

Professionals and experts in our own experiences um and just i’m definitely going to put on my imaginary helmet on we are not necessarily inherently professionals in equity to be professionals in equity we each as a professional have to work at it right when kimberly crenshaw coined intersectionality it was because

Specifically for black women and black women who were poor and black women who were poor and undereducated they were being recognized for either being black in the court court system or being woman but they were not recognized as being black and woman and the reason why that

Is important is that we can be in spaces where communities continue to say this is what i’m experiencing and somebody who looks just like them will say you are not experiencing that or that is not enough for me to focus on and i want to say that because some of our language in

Spaces where all of us have very you know fancy commas and and letters at the end of our name um but i’m a proud girl from trenton new jersey i’m a hood kid great things come from the hood shout out to cardi b like we have to remember

That um and i say carter b intentionally because cardi b is a translator if we are not connecting with individuals that can translate the intentions of all the experts on this panel who at times may communicate from a space of the expertise that they’re in but maybe not the expertise of where

People are at that we can really miss people and that adds to a layer of distrust where people see people that look like them but then they start to assume that they work for the man so i just want to put that out there because it’s really important for

Us to see the experiences that we have as not just beginning with when we went to school but really from our experiences that we we saw the painful experiences of our mothers um of our grandparents of for those of us that have immigrant connections and use that

As the driver of how we connect the facts that we know with the communities that do live intersectional realities because as joe said and as tracy eloquently stated if we make it that um it is that this that this is about i want to save your life and this is don’t

You see what i’m doing what we sometimes miss is that it gets translated as oh i’m not smart enough for you i’m not smart enough to let you know what i’m experiencing or what i’m experiencing is not good enough for you to understand and meet me halfway so i think this is a

Critical opportunity for even within black communities and communities of color not just to say black lives matter as an external affirmation but internally how do we make sure that all black lives actually do matter and a lot of that is communication and relational not necessarily the science all right

All right joe you sound like you want to say one quick thing all right so i’ll let you jump in here go ahead friend see if she gets me in trouble so so that i would i would say and add one last thing to that that making sure that as you’re

Going through and finding those people that can encode and decode that you also have someone that’s writing down the dictionary right because one set of encoding and decoding for one population may not translate well the way my football players talk is not the same as my basketball players and how

They express pain and how they express the way that something is happening with their body is not something that someone on the other side of the table may be used to so finding someone that can help understand and translate that language is very important and also it’s very

Important that we document that so that the next group of people coming along don’t have to reinvent the wheel every time we go through this because that also sets up another barrier to participating in clinical trials yeah excellent excellent just shows that we are not a monolith right we that there’s

Diversity even within diverse groups so i appreciate that um i want to quickly get some thoughts from uh marion and ron again um where we’ve we’ve said a lot we said a mouthful about some of the challenges here so if you were to think about how you were

Going to prioritize the three top barriers to clinical trial enrollment with ethnic minorities how would you prioritize those and so marion will start with you and then we’ll go over to ron so so i think everyone has said we have to build trust as the foundation right

If people don’t trust you they’re not going to engage and even if they engage they’re not going to continue in the process for the clinical trial so there are a couple of things that i i that have been said about trust so i think first of all is the investigators right

So how do we increase the diversity of the investigators the people that are actually going to be administering the trial and that’s something that’s critically important that we’re focusing on here at novartis as well as with the former trade association there’s so many great minds out there people of color

That are not getting the opportunities because of what was said earlier oh they’ve worked so well with this person in the past how do we break that up right and give opportunities to people who have the credentials that are ready now that can engage and increase the diversity of our clinical trials so

That’s on the front on the back end is recruiting so when you are going to recruit someone for anything they have to have someone on the other side of the table that they trust and it’s for me it’s low-hanging fruit and it’s one of the things that

We’re doing at novartis now that i’ve been pushing since last year but we’re finally at the stage where we’re going to be partnering with associations healthcare associations for people of color so if you are looking for patients that are african-american to be in a trial why aren’t we going to

The american medical association why aren’t we going to the black nurses and so they trust them they know who the patients are it’s it’s a simple fix on the recruitment part from my perspective because they trust them but we also have to make sure we have those associations

At the front end as well the design the locations all of those things they need to have a voice there so they trust the process and then when they trust the process they can in turn have their patients trust the process so trust is number one for me

I know you can’t tell everyone the same story the same way and expect for them to digest it so you have to meet people where they are and you can’t just put a black face or a latinx face on the cover of something or you can’t just translate it into chinese

Or to spanish you have to be intentional you have to be invested in making sure that you’ve done the research that you brought the right people to the table to be able to create a message that is digestible for different populations around clinical trials we’ve spoken about all the mistrust and all of

The issues that we have and they are real and they resonate i’ve heard for generations about tuskegee and all of those things the ob gyn situation with the enslaved women and no anesthesia all of those things so it’s a scary thing for someone who’s been in the pharmaceutical industry for over 20 years

So with that how do we craft our messages more effectively to meet the population where they are and then the third thing is around access and location so picking the right location picking the right medical facilities the right hospitals not having people to need to travel 50 miles

To participate it’s not realistic how are we using innovation and telemedicine how do we do use those types of things and really think outside of the box to ensure that all people have access and a seat at the table and the other thing about access is around patient

Assistance programs so one of the things we did and courtney i heard you speaking about the sickle cell population with our most recent trials for sickle cell we created a patient assistance program well we reimbursed them for travel for those who had to stay overnight we created a situation where we could pay

For hotel stays and things of that sort so i think there has to be a broader uh commitment to true access and when you talk about intersectionality you’re looking at the economic part the gender part you’re a working mother right and single mother working how do you participate in a

Clinical trial and take care of your family we have to do more to support because it matters that they are in the clinical trials so we get the best product for all patients that someone said not just some patients excellent thank you marion ron anything you’d like to add ron bailey

Absolutely i think that the uh comments of era are timely uh clearly um these programs are essential so we can communicate fairly well i think across a full spectrum of groups we’ve had for 26 years now an entity in the national medical association entitled project impact uh

To exactly what he mentioned to really link private practice after american positions we have forty thousand in our organizations across the country a very often who might not be specifically researchers who have large african-american patient populations uh most importantly as i think mayor brooks points out very correctly they

Have the trust and the therapeutic alliance with the patients where the patients like to believe in them i’ll give an example i was the chairman of psychiatry at wake forest for five years 14 to 19 before i moved out here and each year in order to get more blacks in north

Carolina and cancer research there’d be a big event actually twice a year where the african physicians would come meet the researchers unfortunately we only have one african-american oncological researcher there and really work together to enhance i think a bi-directional communication so they can funnel patients who are african-american into

Um cancer oncology research trials they’re at um they’re at wake forest so i think these are the kind of projects that we can actually work together on and and foster or manifest i think a process where more african-americans could actually be in trials who would normally get a letter of communication

From a doctor at the wake forest of the world and participate i appreciate that thank you so much and these are the type of innovative things that i believe in in partnership with you all is really going to move the needle um but there is something that is

Very immediate and urgent and this is coded right we started talking about this in the opening remarks and we know that while it has been a global pandemic for every country across the world that it has wreaked havoc on black and brown and indigenous communities particularly here in the u.s

And so would love to hear jacqueline from you and from brian what are some of the early learnings that we have around ethnic minorities who have uh enrolled in the trial and things that we could potentially take moving forward so bryant will start with you and then jacqueline will go over to you

Great thank you um well i think it’s uh still a little too early to tell in terms of you know learnings in terms of outcomes uh from a uh race perspective however um what’s what’s i think what’s abundantly clear is that our numbers are uh traditionally our lowest as tradition

Has uh dictated i think we’re seeing about consistently about 20 enrollment in these populations and charles i’ll let jacqueline speak for uh speak for pfizer but at least from what i’ve seen quoted recently in moderna they’re at about 20 um new england journal of medicine just

Reported out on uh act one trial where again they they were reporting out at about twenty percent uh but dr fauci is calling for numbers um in some cases uh at least double uh two to three times that given the disproportionality of the um the impact uh in our communities

Um but i think if anything you know if you want to say i don’t think that there’s really a true blessing here but something that was just mentioned um on the last question is that i think that um covet is is certainly going to like everything it’s going to change the way

Um we run trials it’s going to change the way we interact with our communities virtualization of clinical trials is something that’s been talked about um for for years and now you know we’re seeing you know my mother is using zoom uh is using telemedicine um the all the barriers uh

That we in some cases have our community has put up uh for the patient are being challenged and broken down because we were put in a situation whereby um we we have no other means but to reach out to to our communities in different ways um

Working with um dr jenna andrews and dr kevin holcomb out of cornell on looking at the ways that uh healthcare utilization has been disproportionately impacted uh in our communities and the early information is bearing out that that is the case particularly i think in an oncology

Um so i i think it’s again it’s a little too early to tell but the but the the early signs are are clear that one we’re still conceiving uh a continuation of of what we already know is that we are are low in our participation but

On the other side uh we we see enough there’s an opportunity here for us to change the way we are conducting clinical trials so that we can uh reach our communities in different ways in ways as as as others have said we can sort of meet them where they are

And talk in the language that they’re accustomed to communicating with us all right jacqueline yes um just to echo what brian and marian said um is that we have to rethink how we approach the trials and so we did that you know because this global pandemic it does not discriminate it everyone is

Being impacted probably everyone on this call knows someone directly either in their family or friend that has been impacted by kovic 19. that said they’re still reluctant of the african-american community as well as the other latinx and you know indian population american native americans to participate

But what we did the approach and um as brian mentioned the outcome learnings will not come to the end until the study’s completed but where we can focus in is more on recruitment and what we did try to do as marian had talked about in the industry gets it we did reach out

To a lot of our grassroots and medical and legislative community we were on several calls going over our protocol going over our materials and so we learned that we have to get that voice you know we have reached out to the national medical association national black nurses 100 black men

And we were on calls with them and they would say hey wait a minute we think you should do this and we actually held up one day to kind of incorporate some of that feedback we’re starting now but we know that this kind of partnership and this kind of

Communication needs to continue to go on however one of the things we also know is transparency is key and so what we’ve been doing is that we have posted on our website and every monday you can go on our website and look at our numbers and so we’re almost 65

Done with recruiting in the study we have about 48 globally in terms of minority representation and that’s cross across minority populations and then in the us it’s about 28 but if you dig down deeper in terms of the african-american community it’s probably about nine percent are we

Where we need to be no because we know that there’s going to be that reluctance but we are working at it we are trying and we are and we have what we are um our clinical trial diversity center and i am spending a lot more time working with our clinical trial diversity center

Um learning from them and working with them and it’s a two-way street we have a multicultural center of excellence and where we have an advisory board where we include all of these different voices so that we can try to get it right in the community

Yeah one other thing if i if i can add one of the things he just reminded me of something i just want to put it into the context of us being gathered here today representing the d9 um you know i serve as the health and wellness chairman of

My of my chapter we have a captive audience you know all who have uh a captive audience in our chapters in our in our organizations um i put uh uh congressman kelly mentioned uh that we are disproportionately impacted in eight of the the top 10 morbidities uh mortalities uh

At the top of in her introduction i i know exactly the slide the the slide that she’s referring to and i presented at my chapter meeting uh at my first chapter meeting as part of my committee report every year and when we got hit with this pandemic and saw

How it ravaged our communities and then you have to make the linkage to the underlying diseases where again you know you go back to that chart that that’s the source and i think it’s it’s important that as much as we’re talking about you know clinical trials uh and and treatments prevention

Ultimately will win over treatment any day so i i think that it’s it’s just important to for us to say that you know we can’t put this all on the patient um whether it’s the patient enrolling in the trial or the patient being the the

Perfect patient for us to to to meet the in the eligibility and inclusion criteria um we still have to do the work of ensuring that our communities understand that wellness and health uh is is always uh uh best placed in in their hands and empowered if they they take

A perspective of prevention because as we can see you know the other side of treatment is not always guaranteed as well when we start to think about um the sentiment that the public has already voiced over whether or not they’re actually going to take or trust the the vaccines fantastic

All right so we are getting in the home stretch of our conversation and with that i’m gonna do a little bit of a costume change right boom these are the new glasses across my glasses is this gold bar what is the new gold standard that we’re going to set as

We move into clinical trial enrollment okay so one of the things i want to start off this conversation with is myth busters how do we start to bust some of the myths that we have around clinical trial enrollment with ethnic minorities and so tracy i’m going to start you off with

This conversation and ruin i would love to get your perspective as well yeah i mean i think there’s a couple of things first i love the gold glasses second um there are a couple of things that i think we need to challenge the assumptions on um and one is this uh

Notion that if we just make clinical trials more widely available that in and of itself is not enough as we have heard um tonight so that’s one we really have to figure this uh trust thing out and figure it out fast two um i do want to challenge this notion i’m

Not a doctor so all the doctors in the house can can help me with that as a person living with diabetes um you know i am often uh not able to participate in clinical trials because i have i live with a chronic disease and then when you think about living with a

A chronic disease 98 of the adults um you know with type 2 have at least one or more chronic conditions or co-morbidities that they’re they’re living with and so we get dropped out of all of that and so then you add on top of that the disproportionate

Number of people uh of color african americans hispanics living with diabetes the pool size comes down so my challenge is if we have another a chronic condition and or another comorbidity that goes along with that how can we evolve the clinical trial space so that more of us can actually participate

Um that’s number two and number three piggybacking on what uh joe talked about um you know the investigators and having people who look like you yes for sure and then i want to add on there that we need to make sure that we start uh for all providers so that we can reach

Maximum all providers need to have a biased implicit bias some kind of training because the bias is inherent and is real so how can we actually start to provide some training um for all pro you know providers uh so that we can increase uh training that’s providers doctors uh researchers uh

All of the above definitely all um great points that tracy illustrated and just adding on to that that also the glass this the glass change was amazing um simple but effective and i think that tracy hits highlights such a great point um at moffat you know one of the things that i’m currently

Working on is structuring studies with our population science group around multi-morbidities and that’s exactly what tracy illustrated you know understanding those other factors that patients have to go through that let’s say you have diabetes it’s not just you’re getting dropped from certain studies but you’re getting the run

Around in terms of handling your specific um situation with diabetes and if you add cancer on top of that you don’t know who to go to and who’s handling which you know who’s on person who’s on second for each disease so do our providers and i’m speaking on this

Purely from an institutional perspective because i think we’ve hit a lot about the perspectives of what are some of the myths that that ail our communities in us getting to this ultimate goal but do our providers understand what are the multitude of different things that the

Patients have to go through they do not you know 80 to 90 of uh clinical trials being primarily and predominantly white our communities and minority communities don’t have the same things that they have to deal with and it’s not just about getting people on clinical trials but

How do you sustain them on the clinical trial when you’re on it because that’s something else that’s not talked about as well um in terms of adherence to that particular drug or adherence to that particular regimen and that’s something that we’re not as much talking about in

Terms of for you got them recruited but now how do you get them to stay there i think there’s a big myth going around that a lot of minorities are not willing to participate and minorities several studies have found through several several prominent institutions such as

You know yale being one of them that minorities are very willing to participate but i think that the stigma um follows them and it’s something that said before um you know ron and brian uh said this as well as are you marketing or mary and i’m sorry marion and bryant

Said this are you marketing appropriately to these communities not just diversifying or advancing your marketing but making sure that you’re targeted sometimes i cringe when i see marketing efforts even at my own institution where the folks on the marketing uh flyer or video or what have you or all of one particular um

Diaspora or a demographic and that’s just not going to get it done people want to be relatable people people want something to be able to relate to them people want something to be able to understand them and then also it in the same vein is i am doing enough and if your conclusion

Is that you know the myth that i am doing enough as a provider or as an institution if you are not being intentional which is one of the key words that several of us have tried to drive home if you are not being intentional about your diversity efforts

In terms of stakeholders on either side receiving the treatment and providing the treatment or planning for the treatment then there is that myth there that we have to debunk that we are doing enough which we as institutions and organizations can always be doing more then jacqueline i think you had a very

Quick comment that you wanted to add you’re good all right okay no worries so i live in minneapolis minnesota so i uh was here may 25th when the uh video that went around the world with george floyd was seen i’ve been out in the protest um i have

Been uh on the front lines and i have felt the the palpable change in the air um and i pray that that’s not just here in minneapolis but that this is global i almost choke up you can think about it right now um but i i want to hear from joe and courtney

With this context that we’re currently in what is different what is now sustainable that may not have been even pre-covered or pre-uh may 25th uh joe we’ll start with you this time and then courtney will go to you what is most sustainable is the way that people are paying attention well first

Because everybody’s at home and most of people are still working from home or either unemployed or furloughed so now people have more time to research and look into things that they previously had no time to do because they were rushing from one place to the other so

Now we have the opportunity to do some of those educational things that have just been talked about by coming up with a more common frame of reference and also using different marketing tools to try to get people interested not only in what is happening around them right now

Everyone sees covert 19 everyone knows that they’re talking about vaccines but no one’s really connecting the dots between how we get from where we are to where we need to be in order for us to move on to the next level of how we can

Be back to a sense of normalcy so the question becomes how do we find those translators i think what i think what was said earlier about cardi b being a translator in some of these spaces bringing more people into the tent to help understand some things that that

Previously had not been talked about is something that perhaps more principal investigators more people that work on clinical trials and more people in these spaces can take to heart find some people who can speak this language and spend some time not only educating them but figuring out from them so that they

Can educate you on how to reach the people that they talk to every day they’re on tick tock they’re on twitter they’re on instagram and they’re telling people you know i ain’t trusting whatever vaccine come out first and they don’t really have a reason to say like they hear they’ve heard the

Rumors and they’ve heard some of the stories and they’ve talked to their grandparents and maybe they heard something one time about something that happened a long time ago in a history class but now they have that general sense of distrust and it’s not really helping so how can you find the

Validators that are also at home with these people in the relationship building how are you going to do the work and i think that if we are willing to do the work if we are willing to break down uh some of these barriers that have existed for quite some time then we

Would probably have better outcomes but i also think one of the more important things about and i keep referencing cardi b but one of the more important things about that is the points about intersectionality that were brought up earlier if you get the message to black women if

You get the message to black women if you get the message to black women it has a way of reaching many other cultures quite faster than it does with any other population that’s just the way that it is so we’re trying to make this thing sustainable finding the people

That are validators in those spaces that we know work could be very helpful to us excellent point uh courtney love to hear from you yeah so i would say that definitely um not just minneapolis or people have been severely impacted by this is people all over the country all

Over the world and because of that you know people of all colors and now um programs are being developed with the goal of increasing and promoting diversity so the nih has a program called seal which is specific for kova 19 where there’s two purposes the first is to increase awareness

And education in order to overcome these barriers with trust but another important one is that they’re promoting and facilitating enrollment of people of diverse backgrounds african-americans onto these clinical trials that are looking at vaccine and treatment development so i’m really excited about these programs that are going to develop to make sure the

Specific goal of making sure that diversity is increased so appreciate that and then ruan will have you add some additional commentary here yes and i think um just very quickly i think when we talk about what’s so different about this context and as we’ve seen um so very vividly with the social justice

Movements that have been going on all around the country um technology technology is different i mean technology is there and it’s it’s the ability and the advent to be able to utilize that in mass media and be able to create have owned media be so

You know uh prevalent in in in our every day and joe mentioned in regards to tick tock and you know if you mentioned it in terms of the the translators and what have you technology and the utilization of that um is at our fingertips and so the ability of our organizations to

Utilize that as well to be able to reprogram what we think of clinical trials we’ve all seen the new um netflix show maybe or heard about the netflix show um that talks about social media and how social media now you’re back on okay keep going you were talking about the social experiment

Yeah yes so it’s a social experiment you know utilizing that same uh tool to be able to convey to our audiences specifically in minority communities can have long lasting effects as it has with the social justice movement that we’ve seen so i would say the technology is one thing that i think

At its at its height right now is available to us and it is current that that that is different okay so now let’s hear about some of the things that have worked right we’ve been talking about some strategies but uh it’s different to have strategies that actually didn’t go into action and so

Would love to hear bryant from you about some strategies turn action that are moving the needle and then marion from you as well from your seat would love to hear about what you see work uh to help increase minority uh trial enrollment and that have been effective

Building up the trust that we need with that community yeah thank you so i i think um i’ll point to uh there’s actually an encouraging thing is that there’s there’s no um there’s no lack of organizations i think at this point that are making an effort or contributing to addressing this this issue

Individually and collectively um i didn’t mention it earlier but there’s actually a consortium um across the industry across data providers um across academia that is converging on the the kobit 19 topic if you go to i think it’s covid19researchdatabase.org you’ll see the organizations that are represented i think a few uh here today

There where we are collectively in a non-compete um sharing data and looking at ways to well taking a data driven approach to these problems uh generating evidence and insights into you know how patients or populations are being differentially affected by covid uh uh by covet um there’s a great organization

Called uh lazarus uh that is again taking a a data-driven approach at looking at um something that was mentioned earlier which is really fundamentally the readiness of patients uh to participate in a trial um not simply putting the burden on them of you know signing a consent and signing up

For something in it making it such an important decision in a in a dire situation but really taking a a strategic methodological tactical approach to understanding what predicts what are the parameters that predict the successful patient this the the situation um the would be it socially be

It financially um really taking uh a very uh structured approach there um i i don’t want to mention any of my clients but uh fundamentally collectively i’m seeing a lot of organizations um looking at data uh to benchmark uh where they are in comparison to to others um

Taking different strategies to uh see what’s successful in particular indications in terms of um you know looking at the indications that are disproportionately affecting our communities and then looking at the sites and locations that where where we are looking at um catchment information to see you know uh

As reported to the nih whether or not they have a chance to actually recruit the patient and basically as said earlier um meet people where they are and then the last one i’ll shout out dr sandoval um who’s who spoke at uh our conference last year uh his his

Wonderful uh program to salute to familia actually won an emmy uh this year for his work in educating um the latin mex community on uh clinical trials so um i think from in summary basically we’re taking a um a village approach um as represented on this uh on this panel

We have uh quite a few uh industries um represented and the solutions that we’re seeing we’re seeing a collective effort across not just from the pharma industry or even the fda who’s doing a great job with the office of minority health and health equity i have to shout them out as well

Um in terms of really taking um a multi-pronged approach because this is not a sort of a one size it’s not a one size uh fits all uh problem so we we’re gonna need a a solution that’s uh that’s not one size fits all as well marian would love to hear from you

Well yes i think ryan uh said it all uh to be honest with you uh he hit on all of the key points and i think when you listen to what courtney and what jacqueline described earlier those are great examples of how we’re getting it done at this moment uh the other thing

Going back to the last question that i think fits into this as well is around what’s different now and i think it’s sharing and listening right so when you look when uh what brian was just saying when you look at the pharma trade association you look at

The fda people are not trying to do this by themselves anymore they’re saying how do we all come together as a collective to get this done so i think that’s something that’s very different because you know in the past you know you want to be the first one out there so you

Kind of hold all your information everyone is sharing right now so i think that’s something that’s very different and that’s going to help us to propel and move uh forward quicker another thing i think is around being intentional and committed you’ll be surprised what you can get

Done just by being intentional about it and being committed so uh and i think the listening part as well as the sharing is also critically important so i’ll give you a great example in our community we make a lot of assumptions sometimes that other people understand our plight that they’ve heard the

Stories about tuskegee and henrietta labs and all of those things over and over but they haven’t and we can say well they should but they haven’t so how open are we to educate so we had a program on juneteenth and it was called um june 10th generational trauma and mental health in

The african-american community and we talked about the impact of slavery as well as juneteenth on health care disparities today you would have been shocked at how many caucasian people were crying i had no idea so we have to make sure we’re open to sharing as well as listening and then

Collaborating more broadly uh not inside finals and i think those are the answers to the problem i think you’re giving us some really good ideas and some really great feedback so thank you both bryant and marion um john here’s a question for you and also to you jacqueline as we think about

Moving the needle forward what stakeholders need to be engaged and educated around this journey of the benefits of minorities being enrolled in clinical trials and are there specific messages maybe i should say that uh by stakeholder that we need to also elevate sure you know i i wrote down what i

Think the major stakeholders are um the fda um who’s responsible for regulating these drugs that come to market the sponsors which are the drug companies middle of artists and pfizers of the world but a key point for people who may not be involved in how drugs come to market are the

Clinical research organizations the cro and they’re often responsible for selecting the sites and guiding the study and i’ll give a quick antidote we once did a study where it was a pediatric study small study with six sites and it turns out that the investigator meeting was held in salt

Lake city utah and the reason they chose that is that they had four of their sites were in utah so we could imagine what the demographics of that study looked like and i just remember that and remember going out of there i love utah never had

Been there never had a reason to go there and love the city but i immediately thought to myself i guess i’m going to be responsible for all the minority enrollment in this study and so i think we need to make sure we educate the cros and so i think those are some

Of the major stakeholders who are really the ones who determine the design of the study the site selection and ultimately for the fda to say look if you want to bring these drugs to market we need to see that it’s been properly studied in the target population are the population who will ultimately

Be taking these medications and i think if that message is conveyed i think ultimately eventually they’ll get through and then be as we’ve said earlier much more intentional about getting minorities involved in their studies thank you for that excellent jacqueline let’s hear some of your wisdom still on mute

Okay jacqueline we will come back to you up okay there you are okay okay sorry about that no worries okay um i think what we’ve learned in terms of stakeholders is that you know it’s gonna take you know all of us coming together as john has said

We can as sponsors we can do everything in our power to bring forward new drugs and new medications you know but if especially with this vaccine if if if people don’t trust us then they’re not going to take it so we have to do our best to include

All the voices the fdas the physicians the community voices the trusted voices the grassroot organization but we have to include the patients as well and one of the things that we’re starting to do and we need to make sure when we’re doing it we get the diversity in the

Voice but now when we’re designing our protocols we’re getting input from the advocacy groups we’re getting input from actual patients that have participated in other studies and so we just need to turn that up a little bit and make sure we’re including diversity in the voice

Of the patient we need to include you know our churches everybody needs to be a part of this so that we can start to build the trust so we can help people come along it has to be a two-way dialogue as someone said we have to share we have to listen

But we also have to all come along together and another thing that someone mentioned that we need to do and we are starting to look at this is that we do need to make sure that we’re training at all levels on cultural sensitivity on the importance of clinical diversity because that’s um

Someone mentioned everybody’s not aware of our story everybody’s not aware of what has been unfortunately all the abuses that have happened since slavery so we need to be open we need to talk more and we need to include everybody around the table so that we can make sustainable differences

So that we can have equity and inclusion in our trials and therefore hopefully reduce health care disparities in the long run because that’s what we’re doing this for excellent excellent excellent and then for our last formal question here um listen everybody on this call is part of

The denial the divine nine family which means you’re all educated we do have a lot of commas after each of our names right but what we want to do is make sure that our strategy is translating to the patients so i really want to hear from

Dr ron and from ephoma how do we take all of these big strategies all of these five syllable words and make them translatable and transferable to the people that we’re trying to reach the most which are ultimately our patience so ron will start with you and if we’ll

Give you the closing remarks on that well i i think it’s well uh because i think that the comments today have been outstanding and you really heard i think a very nice network of ideas and whether to be coordinated one can only imagine how a full community is how would the

Magic could benefit uh for me i think one way to address it is to look at to get community stakeholders that very often i think um may not be strictly in the um educational academic side but have a tremendous amount of community support be that our churches and our community

Organizations i think uh pastors are very popular in the community uh that i come from in houston texas where if you really want to you know get your message out you want the large pastoral large churches to support it except how often gives i’m a psychiatrist by training and

Many years ago if you had a health fair there’d be no depression screening next to the high blood pressure screening or things of that nature and now i think that as pastors have actually come into the mode and appreciate that depression screening is as important as uh cholesterol screening and have leftover

Screening you set it at all settings and we actually pick up a lot more of these depression concerns i think in those type videos so clearly i do have to kind of recognize which individuals and communities are likely to be heard and can actually move and get people to

Change their behavior i think community stakeholders and community leaders not only politicians or people who individuals believe in a lot of focus on the word trust today i sort of support that i think that uh that’s how you coordinate i think a linked network of ideas as you can get

People to join one of my final points is because click research is i think very indicative of many other areas of life you have to get people to move outside their comfort zone i think i’ve heard a lot about that today we got to find ways to get persons to do what’s actually

Best for them individually the long best part i think overall community society but it may take a bit of a push i think this kind of support accurate information uh ways to alleviate and address fear are those successful strategies kind of moving forward i really like what i’ve heard

Today many good ideas that i think we should implement yeah so um you know i hate the term herd immunity i get it i understand it’s important as a people that have been seen as animals i think there’s a different way that we

Can look at it um i like to think of it as village immunity um and the reason why i think village immunity is a little different than herd immunity is because um as we start to embrace our equity um in society i i wanna tail the question you asked about what

Has changed and the reality is um what has changed is that what’s driving america are not only our people it’s the individuals on the margins it’s the individuals who are the most poor it’s the individuals who are the most vulnerable it’s the individuals that based off of whatever is on their

Certificate or whatever is in their bank account um wouldn’t qualify them if we’re honest with ourselves to even enter many of our offices and yet we are seeing laws and policies that are changing at rapid rates that even legislation um has not been able to do

And what what is my point about that um i believe in the village i believe um that our stakeholders include the church leaders and the person on the corner who gives their own hood prophecy i believe that there is there are individuals who actually are data scientists for black

Lives doctors for black lives data for black lives that should also be speaking with individuals on this call about what is it what does it look like to have both the science and the community-centered people-centered approaches um dare to blend with each other because at times if we’re honest with

Ourselves they compete there’s there’s a feeling of you know whose voice is going to matter more at the table so when i think of what our strategy should think of or should consist of i’m thinking that even with this group and i know we have a lot on our plate

Um but i am willing to see how we move forward since we have a range of both social justice as well as expert uh expertise um on a community awareness model that doesn’t rush just to get us to trial i know that that’s the goal

That we all want to get to but the reality is we have some steps to get to and trust is not something we should rush we should figure out how we design messaging that talks about trusting uh the the those that have our best interests in these spaces while also

Making sure that we are healthy and that the two are not mutually exclusive that is a priority and we need to make sure that the individuals we’ve identified that are credible messengers are part of that strategy number two i wasn’t joking when i put in the comment you have to

Pay us in equity um it is beyond time that those who have been on the streets those who have been changing whether it’s in florida restoration rights or in the midwest where law enforcement is being redesigned we need a movement in the medical space that’s just as crucial

As that so what does it mean for us to invest in the individuals that are at the front lines that already have the ears of individuals because they are trusted and they’ve proven to their communities that even in the midst of kova they are willing to fight for them

You all have the language so how do we get that battery pack into the individuals that are already doing this information and then how do we invest in them for the long term not just for the one time canvassing but what does it look like for them to then be a part of

Our formal institution of of medicine and that leads to my final point i think we have to look at professional professionalizing equity and advocacy very differently that there are individuals right now as young as high school all the way to individuals that may have been retired

That are crucial to how this work gets done they can no longer just be consultants that come in once or twice when we need them that still feels like being a guinea pig we actually need to invest in how they are a part of our pharmacies our institutions and our

Communities and look at how that could also be not just a pipeline uh for individuals to be in trials but also an economic pipeline for individuals to be seen and respected in the medical community a and man i think that was an excellent answer from both of our panelists here i want

To transition real quickly to just a couple of questions that we’ve been receiving uh from our audience and the majority of them have been focused on black investigators so i want to pose this to the panel if you have an answer just raise your hand signal that um but

One question is i’m going to combine them uh a couple of them what’s being done to increase the number of black investigators and is there some sort of database that we can reference or use that shows where some of these investigators currently sit so anyone want to take all right ron

We’ll start with you uh yeah briefly um i think you mentioned earlier i’m the chairman of the board of the mma uh foundation we’re called the cobb research institute and we have a 200 person network of cobb scholars who are young biomedical scientists investigators uh the md and phds within

10 years of completing their terminal degree uh the goal is to uh provide mentorship and networking for issues just like this uh whatever you’re an african provider or a trainee and you’re getting your phd an hour and no other individuals who are african-american or who have similar interests as you or

Really just believe that thinking these issues in this moment or we may pair you with someone who may be in chicago or miami or los angeles where i am right now because being programs like ours and others as well i think are going to be essential for us to develop what i like

To call the network uh which i think strictest ideas but also provides i think much of the career lifelong support that persons need to foster an academic career and perhaps uh engaged in this type of work i also want to add that we do look for ways to partner with

Industry to provide funding for these kind of approaches kind of going forward yeah tracy please go ahead jump in there as well again from the american diabetes association this is this is critical and so we have some uh minority fellowship awards uh that we’re we’re pushing uh

Do our part we have some post-doctoral awards we have some undergraduate um internship minority undergraduate internship awards as well as junior faculty uh awards we need to get more and more uh minorities in the field at large additionally i’m on the um board advisory board for the niddk

Again where we are also trying to attack this issue of lack of diversity in the actual investigators so again lots of work to to be done here but we’ve got to make sure that there’s funding uh to actually keep these these researchers in the field yep excellent and then maybe one last

Question uh since we are running short on time here um i’m actually going to pose this round to you and courtney you probably would have a nice uh perspective on this as well how do academic institutions hold investigators to the commitments for the inclusion of diversity of patients in these clinical

Trials um with some kind of air quotes of they just won’t join so round we’ll start with you and courtney will in with you uh i mean the the short answer is that you know a lot of academic institutions um could do better i think with holding investigators accountable

Um to the inclusion of trials especially because um shortly afterwards i mean academic a lot of academic institutions have very much shifted from a thought process of um trying to shift into a thought process of trying to be the best at all costs and rising up the rankings and that has

Dominated um if they could meet certain criterias and a lot of times having diverse and inclusive um environments are not part of that uh criteria to rise up those rankings and so i think that begs the question more so you know how could they uh become a lot better and a

Lot of um academic institutions one of the the results that you’re seeing from a lot of these social justice movements as they’ve started to um and for instance at usf they sent out a team science program and so that team science grant program um has highlighted 25 grant projects that could lead to

More team science to to impact social justice when it comes to health disparities and a lot of institutions have started to do certain things that are of the same stature recognizing that um that diversity is indeed uh valuable and then also um hiring so in their hiring practices and things of that nature

Putting more of an intention on diverse candidate hires that’s been something whereas my other institution monthly cancer center they’ve started to become more intentional about hiring across the different sectors that affect our patient population and that is basic in clinical and translational research um clinical uh providers as well as

Population science and those are that are actually in the communities so and a lot of organizations and institutions can stand to to do more from that yeah so i agree with you on that there needs to be some changes i know as a physician scientist at nih we have to report

What percentage of patients are of african descent what percentage of patients are male versus female but i’m actually not sure what happens with that information and i think with this movement that eyes are being opened and i really believe that there are going to be some positive

Changes um for the better to to really ensure that diversity improves in clinical trials excellent excellent excellent we’re nearing the end of our time here so i’m going to actually have our last question to our panelists it’s going to be a little different than maybe what i had

Initially thought we would do and i just want to go around the horn and have everyone leave one word think of one word as your key takeaway for today’s conversation one word uh for today’s conversation and again we’ll go in the founding order so ron we’ll start with you what is one

Word you want to leave with our audience today trust i love it all right jacqueline we’re coming over to you what’s your one word engagement love it all right marion we’re coming to you next what is your one word partnership partnership love it bryant what is your one word

Of course the nuke would steal my word um intention intention we’ve heard that a lot love that um joe what is your one word compensation compensation love it courtney what is your one word inclusivity inclusivity love it john what is your one word diversity diversity love it

Okay who are we effie what is your one word equity equity thank you thank you tracy what is your one word connection connected all right round what is your one word community community and my one word for today’s panel is possibility i want to thank everyone for joining us

In this engaging town hall today if i could have all of my d9 brothers and sisters throw it up just so everyone can see once again who you’re representing thank you all so much for attending today’s call we hope that you got some very tangible and some very real tactics

And strategies that you can take from today’s call we also want to remind you that there are still two more days of the national minority quality form that are taking place and tomorrow’s town hall is actually going to be focused on covid and the 2020 election you will not

Want to miss it so thank you all again for your time for sharing your evening with us and we will talk to you soon let’s go make the world better based on what we heard today thank you all very much enjoyed it thanks everybody bye i’m bill bailey i’m here he did

That’s what i’m doing well i’m not seeing him face to face just finished nina are we done i’m sure she’s still on yeah yeah

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