Including All of Us in Clinical Trials

[MUSIC PLAYING]




JOHN WHYTE: You’re watching


Coronavirus in Context.


I’m Dr. John Whyte, Chief


Medical Officer at WebMD.


You know, there’s a lot


of discussions around the COVID


vaccine–


about are we enrolling


enough minorities.


Well, guess what?


That’s the question


for every clinical trial,


for every drug that we’re


thinking about.


And joining me today to help


provide some insights into how


to get more minority populations


enrolled in clinical trials


is Dr. Ed Ramos.


Dr. Ramos is the Director


of the Digital Clinical Trials


at Scripps Research institute.


Dr. Ramos, thanks for joining.




ED RAMOS: Absolutely.


It’s a pleasure to be here.


Appreciate the invite.




JOHN WHYTE: Let’s start off


with this big research project


that you’re part of called All


of Us.


Good name.


What is that all about?




ED RAMOS: I mean, the name


really sets the tone,


because I think it is paradigm


shifting for the National


Institutes of Health in terms


of the different research


studies


that they’ve supported


in the past.


And that is clearly identifying


that there has been a challenge


in the access


that individuals have


to research studies–


not only the information that


comes out of that


but the opportunity


to participate.


And so All of Us, as a moniker


and as a descriptor


of the study, is really meant


to embrace this new opportunity


to come up with new methods


for truly broadening


participation in research


studies


and having the information that


is gleaned from these studies


be available to all individuals


across the country.




JOHN WHYTE: Now, how is All


of Us doing in terms of getting


minorities to participate


in clinical trials?


You know, I spent time


at the FDA working


on who participates


in clinical trials.


And the numbers are strikingly


low.


You know, even on the site,


I can look and see– and I just


want to read this


to our audience–


that African-Americans are more


likely to suffer


from respiratory ailments


than Caucasian Americans.


But only 1.9%, less than 2%,


of all studies


of respiratory disease


include minority populations.


And you and I both know this is


not unique to respiratory


conditions.


You know, even in diabetes,


it’s typically less than 10%.


And that’s a high number.


But it’s the same for neurology,


for cardiovascular.


How do we change this?




ED RAMOS: Yeah, you know,


unfortunately, that list is


a long one in terms of examples.


And they’ve been


persistent over the decades


regardless


of amazing new breakthroughs


that the NIH has supported


in the past.


And so I think there’s a number


of approaches that are


symbolized and captured


within the All of Us research


program that helped break


that barrier.


So the first is truly rethinking


our relationship


with the participant.


And it’s potentially small


things in terms of what we call


our participants– so moving


away from considering them


subjects, but really considering


them as partners in this effort.


Establishing more


of a bidirectional pipeline


for information,


so ensuring that obviously


the researchers are gleaning


a tremendous amount


from the data that they collect.




But then also what are novel


ways that we can now provide


that back to the participants


so they have


some transparency in terms


of how their data are being


used, but perhaps


more


importantly now insight into,


wow,


this is how I could potentially


think about my own health


and potentially changing


my own health behaviors?


And then ultimately it comes


down to ensuring that


we’re getting boots


on the ground for all


the different types


of communities and populations


that are represented within


the US and recognizing that,


even when you sub-categorize


things in terms of white versus


Latino, as well


as African-Americans–


myself, my father is Puerto


Rican.


My mom’s Peruvian.


So Latino to me culturally means


two very different things.


And just within that group


alone, it’s far from monolithic.


So having this understanding


of what the cultural differences


are potentially within a given


group is extremely important.




JOHN WHYTE: But Dr. Ramos, what


do you say to people– let’s


play devil’s advocate.


A lot of clinical trials


never reach recruitment.


They don’t get done,


and maybe they were


important therapies.


Other trials take much longer


than one would have thought


because of retention.


If we start making it more


difficult,


what some people might argue,


to enroll


a representative sample


of the community–


is that doing a disservice


to some people,


because we’re delaying


potentially lifesaving therapies


that are and take longer


to come?


Is there really this variability


of response based by sex, race,


age, ethnicity?


And I am playing devil’s


advocate.




ED RAMOS: No, no.


I mean, it’s important to always


take a different lens


and framing on things


to understand.


And so a couple of reactions–


one of them, I think there is


just a social justice


perspective to this, ensuring


that there is access


and inclusion to all those


that want to participate


and feel like they have


some level of ownership


in their own health information.


And I think that that’s


at the top of the list.


There’s also, most certainly,


a data-driven, technical answer


to that question as well.


And that is you can take


diseases and disorders,


for example, that we know have


some level


of a genetic underpinning,


for example.




But we also know that there are


environmental influencers that


may affect whether or not there


is an increased predisposition


or susceptibility


to a particular disease.


And so when you start pulling


in these disparate groups,


you’re able to layer


this information–


so an understanding, OK, does


geography really affect, is it


the types of food


that they’re eating,


is it their availability


of green space


to be able to exercise.


And this layering of information


can only be gleaned from being


able to have


this representative sample


and have this diversity in data


collection and lived experience.




JOHN WHYTE: We have study it.


We have to know it.


Yeah, so it’s not just about


equity.




ED RAMOS: You have to study it.


Absolutely.




JOHN WHYTE: But it


is potentially about


variability, as we’ve seen


in hypertension


with African-Americans,


as we’ve seen in women in terms


of some of the aspects


of novel oral anticoagulant.


So you know.


Lots of data to suggest


that there could be differences.


And if we don’t look for them,


we won’t find them.


Now, I have to say I was very


interested in your title


of Director of Digital Clinical


Trials.


And there’s been some discussion


that coronavirus is actually


going to make clinical trials


easier.


And you talk about–


I want to make sure


I read it right–


democratizing clinical trials


and that digital health


is one of the ways to do that.


Can you explain that


to our audience?




ED RAMOS: So for me, it’s


extremely exciting


to be able to explore things


like, what is


the gold the in-clinic standard?


And are there, in fact,


potentially even


off-the-shelf devices that we


could potentially use to get


the same types of data,


recognizing that there are


caveats potentially


in the context of it?


But sometimes the gold standard


in-clinic measurement that you


could potentially lose–


you could potentially gain


this ability now


for continuous measurement


instead


of this episodic measurement.


And that in and of itself


can now take a completely


different picture


of understanding these health


measures for a given individual.


The democratization–




JOHN WHYTE: Has COVID


accelerated these?




ED RAMOS: Yeah, so absolutely.


So to kind of bring that full


circle, I think that this notion


of COVID-19 most certainly


initially shutting down a lot


of the in-person operations


for a lot of health systems–


this wasn’t the reason why we


started the Digital Trial


Center.


But it certainly supported


our philosophy that this,


in fact, can be done even


within a COVID world,


because we’re able to leverage


these technologies


and our approach


in a remote manner.




JOHN WHYTE: Now, people have


been trying to improve


representation of minorities


in clinical trials,


let’s be honest, 20, 30 years.


I have to give a lot of credit


to women’s advocacy groups,


Phyllis Greenberger’s Society


for Women’s Health Research


and others, who have really


promoted inclusion of women.


And there’s been some progress,


but we haven’t seen it


across the board.


What’s your reaction when–


and you probably know this–


that although the vaccine


manufacturers have said they


want to make sure they enroll


minorities, they’ve struggled


with getting minorities?




And there’s no requirement


that they do.


You and I both know.


I don’t think anyone’s going


to say a vaccine is not approved


if they don’t have


a certain percentage


of minorities.


So how do we really change this?


You know, people have been


trying all along.


Do you feel pretty confident


that digital tools


and digital technologies


are finally going to let us make


some progress?




ED RAMOS: I think


the opportunity is there


with the right approach.


I mean, there are most


certainly–


again, kind of taking


your devil’s advocate lens


there, there are scenarios


in which it could exacerbate


certain health disparities,


right, when we start talking


about potential access


to technology.


But for me, it


is a moral requirement to ensure


that especially those that are


underserved, underrepresented,


across so many aspects


of this country


are front and center–


especially knowing the data


that we’ve observed and seen


in terms of the impact


of COVID-19


on Latino communities,


on African-Americans,


and on a number


of other populations


that kind of fall


under this underserved,


underrepresented umbrella.




Will digital technologies


facilitate an improvement in how


we bring in those communities?


Again, I think there is


enormous opportunity for us


to do that.


And that means ensuring–


and it starts


with the participant.


It starts with– you know,


you can take all


of the technology


and digital aspects out of this.


If you don’t have


a right approach in terms of how


you communicate,


how you tell the story of what


it is you’re attempting to do


and what it means


for that person–


if you can’t get over


that initial hump, then it’s


a pretty steep hill for you


to haul in terms of being


able to reach out


to different populations.


But I think part of that comes


with shifting this paradigm


and broadening participation.




JOHN WHYTE: You know, one


population I want to make sure


that we address,


that always seems to be added on


at the end– and I don’t want


to be doing that here.


So I want to make sure we


address rural populations.


And that’s been an area where,


you know, there are lots


of challenges for engaging


with different populations.


And when we talk


about digital tools


and digital technologies,


there are some challenges


in terms of broadband internet.


How do we address the issue


of rural populations?


So we’re not necessarily talking


about specific race, age,


ethnicity, but we’re talking


about geography as you


referenced.




ED RAMOS: Yeah, definitely.


And to be clear, when I


categorize in terms


of underrepresented


and underserved,


it most certainly is not


specific to race and ethnicity.


And geography is a huge part


of that.


Also individuals


in the socioeconomic status–


there’s a whole new set


of considerations


for those populations.


But specific to rural,


you know, I always think


about some


of the early genetic genomic


studies in which you have


this amazing promise of I’m


going to peer into your DNA,


your blueprint.


And I’m going to be


able to espouse all


of these things about you


in terms of family–


you know, explanations


of bad past family history,


ancestry.


And when you paint


this beautiful picture


and you end with “but that’s


only if you can come


into our clinic,” that’s so


deflating for so many


different populations.




But for an approach


and a paradigm


shift that we look to employ


in the Digital Trial Center,


as well as All of Us research


program, are simple things–


like, all right, well, how do we


spin up a salivary kit


in a simple mailing that’s


out to individuals


anywhere in the country that


at least has a US zip code


and access to mail.


The ability to literally just


spit in a tube and send it back,


and be part


of that beautiful picture that


was painted initially,


is extremely gratifying.


So I think it’s those types


of solutions that don’t


necessarily have to be


high tech,


but that you recognize


that there are ways that we can


still bring them into the fold


for all of this cutting edge


research and science


that we’re doing.




JOHN WHYTE: Well, it’s high tech


in the sense


that before people could not


simply– you know,


they’d have to have labs called


and complication.




[INTERPOSING VOICES]




ED RAMOS: That’s right.




JOHN WHYTE: Now we’re spitting


into tubes


and getting our genome.




ED RAMOS: Absolutely, no.


Great point.


Yes.




JOHN WHYTE: What do


clinical trials look like, Dr.


Ramos, five years from now?


Is it all done in the home?


Is it all done through, you


know, sensors and trackers


and robotics?


Take out your crystal ball


and tell us how they’re going


to run.




ED RAMOS: Actually I think


a lot of what you just said


is, in fact, true.


I think that digital health


technologies–


and we’ve seen just amazing


advances


in off-the-shelf devices that


allow for interrogation


of a number of different data


variables.


I do want to convey that there


are opportunities for us


to launch studies


that leverage all


of these wonderful technologies,


but that can still build


a real relationship


with the participant.


And sometimes that’s as simple


as a phone call, as a Zoom call,


as welcoming them into the study


and guiding them


through clinical trial efforts


that require a lot.


That’s a lot of burden


on their end in terms of wearing


different devices and sensors


and so on.


And we’re excited to employ


those strategies as well


and then think about how can we


potentially digitize that as we


look to grow the scope


and grow


the scale for different studies.




JOHN WHYTE: Well Dr. Ramos, I


want to thank you


for your advocacy


for enrolling diverse patient


populations,


for your innovation in research


in digital tools as how we do


that.


And we’re going to check in


with you


and see how we’re doing


over the next couple of years


and in terms of recruitment.




ED RAMOS: Please do.


I’ll look forward to it.




JOHN WHYTE: And I want to thank


you for watching Coronavirus


in Context.