A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design and what success would look like five and 10 years out.
Formed as a working group of the advisory committee to the NIH director (ACD), the team will deliver a preliminary report in September 2015 that will inform efforts to accelerate the understanding of individual differences that play a role in health, with the goal of informing better prevention and treatment strategies tailored for each person.
President Obama launched the new initiative Jan. 30, calling for initial funding of $215 million in his FY2016 budget. Of this total, $130 million would be dedicated to beginning the process of building the group of one million or more research participants who will volunteer to share their biological, environmental, lifestyle and behavioral information and tissue samples with qualified researchers in a way that protects participant privacy. Participant input through representation on the working group, workshops and other feedback mechanisms will be central to the design and implementation of the study.
“Establishing a one million person cohort is an audacious endeavor,” said Francis S. Collins, M.D., Ph.D., NIH director. “But the results from studying such a large group of Americans will build the scientific evidence necessary for moving precision medicine from concept to reality. I’m confident that we’ve pulled together the best of the best in this working group to put us on the right path forward. And we look forward to broad input from a wide cross-section of stakeholders as this process moves forward.”
NIH held a two-day workshop in February to shape the objectives of the working group. To fulfill its charge, the working group will gather additional input from patient and scientific stakeholder groups through a combination of public workshops on precision medicine topics, including privacy, electronic health records, mobile health technologies, existing research cohorts, participant preferences, and inclusion of minority and underserved populations.
External working group on building a research cohort for precision medicine includes:
The working group also will include ex-officio members from the U.S. Department of Defense, U.S. Department of Veteran Affairs, FDA, HHS Office of the National Coordinator for Health Information Technology and White House Office of Science and Technology Policy.