How Groundbreaking NIH Research is Expanding to Birth-to-Four-Year-Olds

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Mark Masselli ( 00:04 ):
Nearly 10 years ago, President Barack Obama said...
Barack Obama ( 00:07 ):
So tonight I'm launching a new precision medicine initiative to bring us closer to curing diseases like
cancer and diabetes, and to give all of us access to the personalized information we need to keep
ourselves and our families healthier.
Margaret Flinter ( 00:21 ):
We are talking with two of the leaders of this project called All of Us. Our guests are Director of
Pediatrics, Dr. Sara Van Dreist, and Principal Investigator, Katrina Yamazaki.
( 00:32 ):
And this is Conversations on Healthcare.
Mark Masselli ( 00:43 ):
Welcome to both of you to Conversations on Healthcare. So great to see you.
Dr. Sara Van Dreist ( 00:48 ):
Thank you so much.
Mark Masselli ( 00:50 ):
Yeah. Let's start off with Dr. Van. Driest. Sara, we know that All of Us program very well as the initiative
selected. Our Community health center is one of your partner organizations, really after a long and very
intense review.
( 01:05 ):
And of course we're very proud to be involved. But maybe you could share with the general public a
little more about the All Of Us Project. How does it work and how is it unique?
Dr. Sara Van Dreist ( 01:17 ):
Yeah, thanks for the opportunity to share a little bit about the program. So the All of Us Research
Program is led by the National Institutes of Health. And the goal is to change that one-size-fits-all
approach to healthcare and to come up with ways to make healthcare personalized or individualized for
each individual.
( 01:37 ):
One of our goals is to partner with over a million individuals who reflect the diversity of the United
States, all 50 states and the US territories. One of the things that really makes the program unique is
that size and that scope and the focus that really entails.
( 01:56 ):
As a researcher, one of the things that my job was before I took this job was to connect the dots, right?
The goal of research is to connect the dots. With a million participants from across the country, there
are so many dots that will be able to connect.
( 02:10 ):

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And it's not focused on one particular disease or one condition, but we want all different kinds of dots
on all different kinds of things. That will enable us to make that healthcare more personal, make that
healthcare better, really for all.

Margaret Flinter ( 02:25 ):
Well, Sarah, let me pull the thread on that a bit. We hear this statistic a lot. Our DNA is more than 99%
the same as everybody else's DNA. So share with our audience why collecting DNA samples from diverse
populations is so important. What do we learn by doing that? And I think also define what you mean by
diverse.

Dr. Sara Van Dreist ( 02:49 ):
Yeah, great. So again, as a scientist, as a pediatrician, and a little bit of a nerd, I'll share that DNA is my
favorite thing. I love DNA.
( 02:59 ):
But as a human being, I think it's just amazing, right? Here's this thing that is so incredibly the same
across every person on the whole planet. And yet at the same time, it is absolutely and completely
unique for each of us. So the fact that you can have both those things in one big, giant, beautiful
molecule, I think, is just fantastic.
( 03:18 ):
And so that uniqueness though is so very important to what we're doing with the program. Because if
we fail to include a group of individuals or an aspect of diversity, then we miss out on that uniqueness.
That limits us and what we're able to understand about humanity in general. It also limits researchers
and learning about that particular group of individuals. And it limits then downstream how clinicians can
care for those individuals and give them the very best possible outcomes.
( 03:49 ):
And so if we want to change this one-size-fits-all approach and make it really fit for each individual, we
need contributions from each unique individual. And when we think about diversity, we think about it
across lots of different dimensions. It's not one thing, it's lots of different aspects. So we think about
diversity in terms of your geographic location, your ancestry. We think about in terms of your
socioeconomic status, we think of it in terms of age and your life experiences.
( 04:17 ):
So those are just a few examples of how we think of diversity. And every single piece of that contributes
to your uniqueness.

Narrarator ( 04:24 ):
We ask for 1 million individuals to come forward and stand on this landmark in history. We ask America
to do, once again, what she has always done. Lead the way forward.
( 04:40 ):
We're one nation, one people, but all of us are different. And it's those very differences that will lead to
answers for generations to come.

Mark Masselli ( 04:57 ):

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Well, speaking of contributions, the federal government has invested three billion into the program, and
last year All of Us made a pivot to start enrolling children. I'm wondering why was this needed and what
types of new protocol development and updates to the program's, platforms needed to take place to
make sure that this was able to happen successfully?

Dr. Sara Van Dreist ( 05:23 ):
So we know that children are approximately 24% of our population in the US, and they are 100% of our
future. So in order to provide them with the very best care for the future, and again, have them benefit
from this amazing resource, we need to include them. Just as we miss out on uniqueness of a group or
individuals that if we leave them out of this opportunity, we miss out on those unique experiences of
childhood if we don't include children in the All of Us Research Program.
( 05:54 ):
It's important to know that the All of Us Research Program always had a priority of including children in
the program. And lots of plans were made since the very beginning. Again, since 10 years ago. And lots
of foundational work was done before I even started with the program two years ago. But then in 2023,
and as you mentioned, we were able to pivot and really focus our attention on pediatric enrollment
because that is a piece that had been missing.
( 06:23 ):
And so it was so incredibly fun. Enabling pediatric participation was the number one priority for the
program in 2023, and we had to do an enormous amount of work. So anybody who's spent more than a
few minutes with a child, whether it be your own or kid next to you in a car at a restaurant or on an
airplane, you realize that every bit of life is a little bit different for a child and to include them in your
experiences, everything has to be a little bit different.
( 06:54 ):
And so we were able to thoughtfully take all those plans and implement them and enroll our very first
participants from the pediatric age group in our program starting in the end of 2023 and extending now
into 2024 and really proud that one of our pediatric enrollment partners is right there at CHCI.

Margaret Flinter ( 07:16 ):
Well, Katrina Yamazaki, you are the principal investigator here at Community Health Center in
Connecticut For All of Us Project. We know you have a personal story involving your children with this
project. Please share it with our audience, if you will.

Katrina Yamazaki ( 07:31 ):
Yeah, I'm welcome to be here. So my story and reason why I feel strongly about the pediatric program is
my husband and I were fortunate enough to adopt three wonderful boys from the foster system in San
Diego. And by adopting them through the system, we don't know a whole lot about their histories and
health, their biological family's medical history.
( 07:56 ):
And the idea that this program will one day be able to provide some of those missing information to me
and my husband in order to become health advocates for our children is really important to me. The
little that we do know from them and the different diseases that did run through their families, we also
think it's really important for our children to help with research to try to really understand how some of
the mental health disorders that do run through their family, how they come about and things like that.

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( 08:32 ):
And so it was really personal for me, in particular, to learn about their health information as well as be
able to contribute to basically the future generations of health.

Mark Masselli ( 08:45 ):
Isn't that wonderful? Thanks so much. And what a great future they're going to have, knowing much
more information about who they are, where they came from, and that's so great.
( 08:56 ):
Katrina, there are so many different challenges in enrolling people in medical research. And we also
know looking at the broad work of research, so often it's been limited to a smaller group of people. And
the program says research should be about all of us, right?
( 09:19 ):
And there are many reasons for hesitancy in enrolling people, and now we're trying to enroll children
from, as you mentioned earlier, from birth to five. I'm wondering what different approaches that we're
taking to make sure that the All of Us effort here is successful.

Katrina Yamazaki ( 09:41 ):
So we have been met with some hesitancy when we are out in the community talking to families about
enrolling their children. We've been taking a really hands-on approach to it by partnering with various
community-based organizations such as libraries and talking with parents at the children's
programming. We have a close partnership with the Harford Public Library where we are doing
educational sessions for children in hope to build trust with the community. So they see us on a weekly,
monthly basis so that they get to know us and slowly raise awareness of the All of Us Research Program
that way.
( 10:23 ):
We're also eliciting the help of our staff at the centers. As we all know, they are more comfortable
talking to their healthcare providers. So anytime a staff can help us raise awareness for the program, we
are definitely working that angle as well.
( 10:42 ):
But really just trying to make a fun atmosphere for the kids when they approach our tables in the
waiting room, showing that we have information for them as well as bringing the kids in, doing fun
activities with them, making them feel included and welcome as we approach them in the waiting room.

Margaret Flinter ( 11:02 ):
There's so many questions that spring forth from this conversation, and I've had the honor of really kind
of a bird's eye view of watching the All of Us stations and different sites and seeing the way our
wonderful staff interact. And I know the program has put a real priority on making sure staff members
also looked like all of us and the people who use the healthcare resources.
( 11:27 ):
But I'm curious, it seems to require a fundamental level of health literacy around genetics and also a fair
amount of trust in the process, if you will, to talk with adults about enrolling to say nothing of children.
And I'm wondering if you're seeing a difference in terms of the willingness of adults to consider the
possibility and sign up to be in the program versus having their kids.

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( 11:56 ):
How is that shaking out or are you tending to see the children of people who are already enrolled and
have already crossed that divide?

Katrina Yamazaki ( 12:06 ):
Yeah, so at least at DHBI, we've been doing a lot of work reaching out to our AAU participants already in
terms of adults and seeing if they're interested in enrolling their kids. We've had a lot of success also
with enrolling new families into the program where we enroll their parents and the children.
( 12:24 ):
A lot of the reasons why the parents that we have been able to engage with over the last year or so is
really their willingness to, again, help with discoveries and research because they have their own chronic
conditions that run through their families that they want to learn more about. And I think really being
able to contribute to research is what the driving motivation for the adults to enroll themselves as well
as their children into the program.
( 12:52 ):
And so we're really looking to give back more of that information of how their information is really
helping biomedical researchers in general.

Mark Masselli ( 13:03 ):
Oh, that's great. Sarah, we are proud to be one of the early federally qualified health centers in the
program. I think there were five of us. But there are 1400 community health centers all across the
country. They serve a very diverse population. And I know more have joined.
( 13:18 ):
But talk about the role, the influence that federally qualified health centers are having on the program.
And for those who are contemplating and participating, maybe lay out some reasons that they should
embrace this very important program.

Dr. Sara Van Dreist ( 13:36 ):
Yeah, I'm proud to say that of our five sites right now that are starting out, our limited enrollment efforts
in the pediatric space, two of them are federally qualified health centers. And that collaboration didn't
start with the start of enrollment. It started far before that, where we were able to get the input of
people like Katrina and others at the federally qualified health centers to give us input. Because those
healthcare providers are absolutely experts in how things work at their health centers and what's going
on in these families lives.
( 14:10 ):
So things like what's an appropriate approach to kids, how can we talk about this research with kids and
families, even just workflow kinds of things. One of the fun things we get to do for the pediatric
participants is provide them with an item that tells them that we appreciate them contributing to the
research. So when they finish their visit with our study staff, they get a toy or a book or those kinds of
things, and we ask the sites themselves, what would be a good thing that would really signify this
appreciation that we have for this family and this child coming in and participating with us?
( 14:51 ):

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And so, we didn't pick those things. Our folks at the sites picked those things in order to provide those
back. And that was one of the most fun parts of last year, is finding all those items and making sure that
they were aligned and that would be approachable to different groups and different ages.
( 15:13 ):
The richness that we're able to provide in terms of an opportunity and that hope, looking forward, that
this is what we know today by contributing a bit of your time to the program, contributing data in the
way that you are comfortable with, we can create a better future. We can create a better way of care.
( 15:37 ):
And we can only do that with everyone's contributions. We don't want to leave anybody out. In order to
do that, we need to partner with great places like our FQHC partners.

Margaret Flinter ( 15:50 ):
Well, Sarah, I know if I look back over the arc of the years, the issue of data privacy and protection was
huge even then. And if anything, I think probably concerns or even greater about that now, given where
we are with technology. I wonder if maybe a two-part question.
( 16:09 ):
How does the All of Us Project ensure personal information is protected and not shared, leaked, or
stolen? And the second is who does have access to it even at this point in terms of being able to use it
for research purposes?
( 16:25 ):
That I understand is already underway, that certain researchers can access it. Is that right? Tell us about
that.

Dr. Sara Van Dreist ( 16:31 ):
That's right. So first let me talk about just in broad strokes some of the things that the program does to
make sure that the data that people do so graciously give to the program is kept safe. We follow federal,
state, and local laws and there are all of those things in place. We are constantly monitoring those and
making sure that we're up to snuff according to the rules.
( 16:57 ):
There are some additional things we do though, however. Number one, when people provide us a lot of
really rich information about themselves, before we give any of that for a researcher to use, the
personal information, anything that could be used to identify that person as an individual, is removed
from the data. And so it's anonymized in a way so that their personal information isn't available even to
the researchers who are using it.
( 17:24 ):
We're continuously monitoring and testing our systems, making sure that all of both the privacy controls
and our security are all working the way we intend and that no one can breach those protocols.
( 17:37 ):
And then it's important to know that all the researchers who want to use the data and even the topics
that they want to study need to be approved by the program before they can move forward. And we do
have the data available to researchers. It's on a site called a researcher workbench. So this is a secure
system where researchers can access the data once they've gone through appropriate training and

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they've been approved to move forward. And then they can use the data in order to answer the
questions that they're interested in and then report that out to the rest of the world in order to, again,
be able to make healthcare better for all of us.
Margaret Flinter ( 18:18 ):
Are there already reports out, Sarah, based on the data that's been collected so far? Have we added?
Dr. Sara Van Dreist ( 18:25 ):
Absolutely. And so the numbers are pretty amazing. So there are about half a million adults who have
fully participated in the program and have their data available and each individual gets to choose their
level of participation in the program. Those data are available on the researcher workbench. We have
over 12,000 researchers from across the country who are using that data set now.
Margaret Flinter ( 18:51 ):
Wow.
Dr. Sara Van Dreist ( 18:51 ):
And this year, 2024, the pace of scientific publications that are coming out in the literature, based on
this data set, is about one new publication every single day.
Mark Masselli ( 19:03 ):
Wow.
Dr. Sara Van Dreist ( 19:03 ):
And so it's a remarkable pace and it's really been picking up now that the data set is large.
( 19:10 ):
Let me just comment. One other thing is a lot of people share their electronic health records data, which
is a wonderful set of... I know I talked earlier about connecting the dots. Electronic health records has
lots of dots in it that researchers can look at. But those also look backwards in time, right? And so we
have adult participants who joined the program whose electronic health records go back and look at
their adolescence and their childhood.
( 19:34 ):
So just one example of a paper that came out recently. Researchers looked at individuals who are
survivors of cancer, who were diagnosed when they were teens or young adults. And so they included
individuals who were 15, 16 years old when they were diagnosed with cancer and then they looked at
their long-term outcomes. So these data are already available and people are making some really
important contributions to figure out what influences health and how we can make it better.
Mark Masselli ( 20:01 ):
Sarah, I know in medical research you have to crawl, walk, and then run. But I'm wondering for families
who have children who are six, seven, and eight years old, how long will they have to wait? I'm sure
they're anxious. They're hearing this great news about the opportunity to know more about their family
members.

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( 20:21 ):
Is there a time horizon for that next tranche? It's birth to five and then is it 18 and over and you're sort
of got that gap there?
Dr. Sara Van Dreist ( 20:32 ):
Right. So right now, adults can enter the program and for the folks who can enroll at our five partner
organizations that are working with us right now, we're open from until that fifth birthday. And we
started with that youngest age group so we could follow them the longest.
( 20:52 ):
But we know that we absolutely can't stop there. Our goal is to make enrollment open to all. And so my
team is already working on the adaptations to the protocols. Again, if you spend time with kids, you
know that being with the three-year-old is very different than being with a ten-year-old. So we're
working on the changes that need to be made to support pediatric participation for the next age group,
which will take us up through childhood and then we'll work on the adolescents.
( 21:18 ):
And at that point we'll be open across all age groups. How fast we're able to move is going to depend on
how much funding we're able to use to keep this moving forward.
Margaret Flinter ( 21:29 ):
I have a question maybe for both of you, because I remember as COVID struck and we had to convert so
much to telehealth and decrease our in-person contacts, if that set the program back very much.
( 21:43 ):
But part two of that question is also in 2020, NIH announced that it would use research materials
collected as part of All of Us to learn about and to maybe address or intervene with the COVID
pandemic. So maybe two pieces, or two questions.
( 22:00 ):
How much did it set you back, the COVID pandemic, in terms of your recruiting efforts? But also do we
have meaningful information that emerged because we had the All of Us Project underway that has
helped us learn more about COVID and how it affects all of us.
Dr. Sara Van Dreist ( 22:19 ):
Katrina, did you want to comment at all about your experience during the COVID Pandemic? That was
before I started with the program, so you have more direct experience with that than I, for sure.
Katrina Yamazaki ( 22:32 ):
Yeah. I know that I personally wasn't here during that time, but I know that the team had a long way to
come, coming out of the pandemic. They pivoted a lot from in-person outreach to phone call outreach,
almost cold calling. And I know the beginning parts of that was challenging, trying to explain a research
program to somebody over the phone instead of seeing them face-to-face.
( 23:02 ):
And I know they had a lot of success with that as more information started to come out and the patients
heard more about it. But it did take numerous phone calls to individuals to explain the program, again,
going back to that trust issue on building rapport with the patients on the phone.

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( 23:23 ):
When we were able to come back in-person and do a lot of in-person outreach, we saw that our
enrollment numbers on the adult side did increase significantly. So there's something to be said for our
staff on the ground in the waiting room for outreach, for sure, for recruitment.

Mark Masselli ( 23:39 ):
That's great. And I think there are lots of people who are listening to this show right now saying, where
do I go to learn more and sign up? So maybe, Katrina, can you take us through the entire process?
Maybe how many appointments and how long they are?
( 23:53 ):
And so for folks, and as well, how people can find out where they can enroll in a program.

Katrina Yamazaki ( 24:00 ):
Mm-hmm. So for our center, we have individuals in the waiting rooms at our Hartford location, as well
as Meriden in New Britain. And we are starting to slowly open it up to other CHP sites in the next few
months. And hopefully we'll be able to meet them in the waiting room.
( 24:20 ):
You can visit our website, JoinAllOfUs.org/hci for more information as well. We are able to do in-person
enrollment to help you with the consents, permissions, and surveys. Usually those appointments take
anywhere from an hour to an hour and a half depending on how much we work with the individuals.
( 24:45 ):
We are definitely able to help individuals over the phone prior to the appointment so that when they
come in person, all we need to do is physical measurements and bio-assessments, which is about 30
minutes. A 30-minute appointment.

Margaret Flinter ( 25:01 ):
And I want to go back, if I can just for a minute to the second half of my question a few moments ago
about did we learn anything more about COVID as a country because we had the All of Us Project
underway? Did we learn anything from our interviews with patients or from biologic specimens that we
collected? Anything to report out on that?

Dr. Sara Van Dreist ( 25:23 ):
Yeah, I think we did learn a lot and we continue to learn a lot. So for one example, although the All of Us
Program had just started out when the pandemic had started, we did have bio-samples from individuals
from late 2019 and early 2020. And when researchers looked at those samples, they were able to show
that in at least five different states, the virus that caused the COVID-19 infection was present before
anyone thought that was before that. So it actually helped inform the trajectories of how this virus
entered our country.
( 26:04 ):
We've also... It's not just about the virus, right? It's about the human being who's trying to live through
that pandemic. There's a series of surveys that were done. And for example, one group looked at
resilience and how resilient people were and how that was associated with depression that was
experienced during the pandemic with so much change and stress and uncertainty at that time. And

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they were able to find the linkages between how much resilience folks had before the pandemic and
their experience with depression.
( 26:36 ):
And so those are just two of many examples and we continue to learn more, but really illustrates the of
having this data set already made rather than trying to start something up in the throes of a very
difficult situation like a pandemic.
Mark Masselli ( 26:52 ):
And Sarah, just one last question. Speaking of difficult situations there, and with the backdrop of great
achievements of this program, we're also seeing that the program is facing a 71% budget reduction over
two fiscal years. This is really quite severe.
( 27:09 ):
How do we adjust? What do people need to do to keep this program going forward?
Dr. Sara Van Dreist ( 27:16 ):
Well, we're encouraging people to have conversations. Make sure that the folks around you know about
the All of Us Research Program, know how important it is, and are aware of the ways that it can
positively impact health in the future.
( 27:33 ):
Certainly for our pediatric work, we're really excited that we have over 150 pediatric participants. But to
reach 150,000 pediatric participants, which is what we need to really fuel the research that we hope to
achieve, then we need adequate, stable, predictable funding to make that happen.
( 27:53 ):
And so we encourage people to continue to have conversations, to continue to reach out, and to stay
tuned. And the best way to do that is to stay connected through our researcher newsletters, our
participant newsletters, and our websites, so that what's going on with the program.
Margaret Flinter ( 28:11 ):
Thank you for joining us, Dr. Sara Van Dreist and Dr. Katrina Yamazaki. And just a reminder to our
audience to be sure to subscribe to our videos on YouTube, find us on Facebook and X with our account
name CHC Radio.
( 28:23 ):
And as always, you can go online to CHCradio.com, sign up for email updates. And also, please share
your thoughts and your comments about the program with us. We love to hear from you. Thanks for
joining us.
( 28:38 ):
This copyrighted program is produced by Conversations on Healthcare and cannot be reproduced or
retransmitted in whole or in part without the express written consent from Community Health Center
Inc. The views expressed by guests are their own, and they do not necessarily reflect the opinion of
conversations on healthcare or its affiliated entities.

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