Guest Directorís Letter: Driving Toward Quadruple Diversity in the All of UsSM Research Program

NIH NIAMS NIAMS
Special Announcement
October 20, 2016

Guest Directorís Letter: Driving Toward Quadruple Diversity in the All of UsSM Research Program

I am delighted to introduce Eric Dishman, Director of the NIH Precision Medicine Initiative (PMI) Cohort Program. Mr. Dishman is leading the effort to build the PMI landmark longitudinal research study of one million or more U.S. volunteers to expand our ability to improve health and treat disease through precision medicine.

If you have comments or questions, please send them to Anita Linde, M.P.P., at lindea@mail.nih.gov.

Stephen I. Katz, M.D., Ph.D.
Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases

Dear Colleagues:

Since its inception, the Precision Medicine Initiative® (PMI) Cohort Program — recently renamed the All of UsSM Research Program — has been deeply committed to diversity. This commitment was inherent in the Presidentís vision when he announced the program in January 2015, with the goal that this massive new effort scale the benefits of precision medicine across health statuses and across populations. Itís a commitment that was also woven deeply into the fabric of the blueprint for the program, as presented in the report of the PMI Working Group to the Advisory Committee to the NIH Director: The Precision Medicine Initiative Cohort Program — Building a Research Foundation for 21st Century Medicine.

Photo of Eric Dishman Eric Dishman
Director
All of UsSM Research Program
Precision Medicine Initiative®
National Institutes of Health

Our commitment to diversity has only deepened as we move toward launching All of Us, a research resource that will be powered by 1 million or more U.S. volunteers who, to advance precision medicine, will share answers to questionnaires, data from their electronic health records (EHRs), physical evaluations, biospecimens, mobile information, and geospatial and environmental data. One key commitment—not unlike the NIAMSí cross-cutting focus on addressing health disparities—is to ensure that the data we collect promotes the benefits of precision health to all populations, not just a privileged few.

I have come to conceptualize the diversity we are driving toward as "quadruple diversity." Quadruple diversity more fully reflects the U.S. richness and variability of our population in order to produce meaningful health outcomes:

Diversity of People: Our goal is for people of all ages, races and ethnicities, sexual orientations, and socioeconomic statuses to join us in this unprecedented effort. To achieve this, we aim to build trust through intensive community outreach and engagement, maintaining the highest standards for security and privacy, and providing a meaningful value proposition to the people who generously share their information with us including through a firm commitment to returning research information. We share with NIAMS the commitment to multicultural outreach and the goal of bringing populations historically underrepresented in biomedical research into the fold — and ensuring that precision medicine discoveries yield meaningful advances to all communities across the United States

Diversity of Health Statuses: The All of Us Research Program is not developing a disease-based cohort; we are working hard to ensure that people from all health statuses join us. This means including young, healthy people, as well as those who are older and who live with specific diseases and conditions such as arthritis and lupus, or other conditions. Some worry that this approach will slow the pace of certain discoveries that would rely on immediately having large cohorts of conditions. But understanding the how, when, why, where, and who of disease progression and health maintenance in the long-term will provide a critical foundation for biomedical advances and act as a cornerstone to advance science.

Diversity of Data Types: Participant questionnaires, data from EHRs, biospecimens like blood and urine, physical evaluations, mobile and wearable sensor data, geospatial and environmental data—our goal is to collect all of these rich data types over time. Together, they will provide nuanced pictures of individuals, their lifestyles, and their environments, yielding the most complex and rich data set of this scale in the world. Such a data set may help advance the diagnosis of many rheumatic, musculoskeletal and skin diseases that collectively affect millions of Americans, reducing the rates of misdiagnoses and delayed treatment. As the program evolves, we will move from "version 1.0" of the core data to later versions that will expand and refine data collections to help us answer pressing questions across a wide range of diseases and conditions, including how to best prevent their development.

Geographic Diversity: Anyone from across the United States can join this research cohort. This is exceptionally challenging, but a core part of our diversity goals. We are actively funding healthcare provider organizations, including integrated delivery networks, regional medical centers, and community health centers, to serve as partners to enroll their patients in All of Us. We are also building interfaces and processes that will allow anyone to directly volunteer for All of Us through a call center, via their smartphone, or a website. We know it will take time to develop strategies for standardized collection of certain data (like physical evaluations and biospecimens) from direct volunteers, and their altruism and answers to critical questionnaires about their health and lifestyle will be invaluable to the program. All of Us will also be available to researchers looking to quickly and efficiently identify and enroll people in clinical research for a variety of conditions, such as rheumatic, musculoskeletal and skin diseases, regardless of where those individuals reside across the country.

Our goals have led to ambitious work. Since June, we have been working to create a major consortium involving more than 35 different institutions to develop the infrastructure and the processes needed to launch All of Us. These range from a data and research center, to a participant technologies center, a biobank, and 10 healthcare provider organizations (soon to expand). By the beginning of 2017, I hope that we will be enrolling participants — but we will not begin until we are confident in our data structure, security, and our ability to provide an amazing experience for volunteers.

It is a privilege to be able to share with the NIAMS community this update on the All of Us Research Program. While I am no expert on the important scientific domains you focus on, I have spent much of my Silicon Valley career conducting and funding research on consumer technologies—especially data from wearables, sensors, and smart phones—that might help prevent, detect, and track the progression of arthritis, musculoskeletal and skin diseases. To accomplish our mission, we need to understand yours—and understand what scientific questions you may have. I hope you will join us on this remarkable journey and — when we are ready to begin our launch — share your support. If you would like to know more about how your organization can engage, please contact precisionmedicine@od.nih.gov.

Sincerely,

Eric Dishman
Director
All of UsSM Research Program
Precision Medicine Initiative®
National Institutes of Health