Including All of Us in Clinical Trials

Coronavirus in Context: Including All of Us in Clinical Trials

  • Published on Oct 2, 2020

Video Transcript


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


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


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


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


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


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


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


importantly now insight into,


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


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


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


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


ED RAMOS: You have to study 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


And there’s been some discussion

that coronavirus is actually

going to make clinical trials


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


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–


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


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


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


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,


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.


ED RAMOS: That’s right.

JOHN WHYTE: Now we’re spitting

into tubes

and getting our genome.

ED RAMOS: Absolutely, no.

Great point.



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


and we’ve seen just amazing


in off-the-shelf devices that

allow for interrogation

of a number of different data


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


for your innovation in research

in digital tools as how we do


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.

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