An Introduction to the All of Us Research Program Skye Stewart February 26, 2018 @AllofUsResearch #JoinAllofUs
What Is Precision Medicine? Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in lifestyle, environment, and biological makeup. It is a radical shift in how each of us can receive the best care possible based on our unique characteristics. 2
Examples of Precision Medicine: Better Tests Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition. 3
The Precision Medicine Initiative (PMI) A federal effort launched in 2015 MISSION: To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care 4
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The All of Us Research Program ⦿ The cornerstone of the larger PMI – led by the NIH ⦿ One million or more volunteers, reflecting the broad diversity of the U.S. ⦿ Opportunities for volunteers to provide data on an ongoing basis ⦿ Data will inform a variety of research studies 6
All of Us Values ⦿ Participation in the All of Us Research ⦿ Data from the program will be broadly Program will be open to interested accessible to empower research individuals ⦿ The program will adhere to the PMI ⦿ The program will reflect the rich Privacy and Trust Principles and the diversity of America PMI Data Security Policy Principles and Framework ⦿ Participants will be partners in the ⦿ The program will be a catalyst for program innovative research programs and ⦿ Trust will be earned through robust policies engagement and full transparency ⦿ Participants will have access to information and data about themselves 7
A Transformational Approach ⦿ Diversity Reflecting the country’s rich diversity to produce meaningful health outcomes for communities historically underrepresented in biomedical research. ⦿ Participation Participants in the All of Us Research Program will be true partners—not patients, not subjects—in the research process ⦿ Data Access Data sharing will be a priority to both researchers and participants 8
Engagement Strategy 9
The Value of Participating in All of Us ⦿ An opportunity to learn some of your own health indicators and get your own data ⦿ An opportunity to fight disease and improve the health of future generations ⦿ The opportunity to ensure that your community is included in the studies that may lead to new understanding and new treatments ⦿ The opportunity to be part of a movement to make our health care more precise, more personal, and more effective 10
The Challenges Before Us ⦿ We must build trust with participants and providers by being open and honest partners. ⦿ We must address concerns and seek expert advice on issues such as: • Privacy and security • How data will be used • How vulnerable populations will be protected (e.g. children) 11
Historical Transgressions in Research
All of Us Research Program: Triple Engagement Strategy Health Care Provider Participant NIH Engagement Organizations Center Partners ⦿ ⦿ Regional medical Scripps Research Institute leads Community and faith- centers “direct volunteer” outreach based organizations with many partners, e.g.: ⦿ ⦿ Federally Qualified Patient advocacy groups ⦿ Health Center pilot sites Walgreens ⦿ Provider associations ⦿ ⦿ Veterans Affairs Blue Cross Blue Shield ⦿ NIH Institutes and medical centers Association Centers ⦿ National Blood Collaborative ⦿ WebMD
Program Infrastructure and Enrolling in All of Us 14
Established Program Infrastructure PARTICIPANT CENTER DATA AND RESEARCH BIOBANK CENTER (DRC) Direct volunteer participant enrollment, digital engagement innovation, & Repository for processing, storing, Big data capture, cleaning, curation, consumer health technologies & sharing biosamples (35+M vials) & sharing in secure environment Scripps Research Institute Mayo Clinic Vanderbilt, Verily, Broad Institute (with multiple partners) PARTICIPANT COMMUNICATIONS & HEALTH CARE ENGAGEMENT TECHNOLOGY PROVIDER ORGS (HPOs) SYSTEMS CENTER Comms, marketing, & design expertise; Clinical & scientific expertise network, engagement coordination & community enrollment & retention of participants partners network Website & mobile apps for participants 20+ regional med centers, FQHCs, VA, Wondros, HCM, future awards to future awards to grow network grow network of community partners Vibrent Health 15
National Network of Inaugural Partners YMCA of Greater Seattle Trans-American Precision Medicine Consortium ACCESS, Arab Community Center for Hudson River Health Care New England Precision Economic and Social Medicine Consortium Services Association Mayo Clinic (Biobank) of Nurses in Community Health Center, Inc. AIDS Care All of Us, Wisconsin APIAHF, Asian & Pacific Islander New York City Precision Medicine Consortium American Health Forum Illinois Precision Medicine Consortium W. Montague Cobb/NMA Health San Francisco General Institute (Cobb Institute) American Medical Association University of Hospital Foundation Pittsburgh Iota Phi Theta Kappa Alpha Psi FiftyForward American Academy of Family Physicians Wondros Cherokee Health Systems UNIDOS US National Minority Quality Forum Vanderbilt Univ. Medical Center, with Broad & Verily (Data and Research Center) Black Women's Health Imperative Scripps Translational Science National Partners National Institute (Participant Center) Southern All of Us Network LULAC, League of United Latin American Citizens Baptist Sigma Convention Gamma Rho California Precision Medicine Jackson-Hinds Comprehensive Regional Medical National Hispanic Medical Association Consortium University of Arizona Health Center NPHC, Eau Claire (w/ Banner Health) American Academy of HIV Medicine Centers San Ysidro Health Center National Cooperative Health Center Pan-Hellenic American Association of Colleges of Nursing Community Council, Inc. Council of Greater FQHCs National Alliance for Hispanic Health Dallas Omega Psi Phi Delta Research and Educational Foundation Community SouthEast Enrollment Center Federal Partners: White House, Partners HHS, NIH, ONC, HRSA, VA, USDS Vibrent (Participant Technology Systems Center) CII & PII Partners HCM
Enrolling in All of Us HEALTH PROVIDER DIRECT VOLUNTEERS ORGANIZATIONS (ENROLLMENT CENTERS) 17
All of Us Research Program Data The program will start by collecting a limited set of standardized data from sources that will include: • Participant surveys • Electronic health records • Physical measurements • Biosamples (blood and urine samples) • Mobile/wearable technologies • Geospatial/environmental data Data types will grow and evolve with science, technology, and trust. 18
Looking Ahead 19
Plans for Launch and Beyond ⦿ We’re working like a technology platform company, centered on the user experience ⦿ Will launch when ready and right ⦿ Phased implementation as we pilot, iterate, and scale ⦿ Over time, anticipate new technologies, protocols, and assays ⦿ Will provide transparency and open access to our protocols to enhance interoperability with other cohorts 20
Learn More: JoinAllofUs.org 21
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