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Home » NIH presents framework for national, large-scale cohort

NIH presents framework for national, large-scale cohort

September 18, 2015
CenterWatch Staff

The National Institutes of Health Advisory Committee to the Director (ACD) has presented to NIH Director Francis S. Collins, M.D., Ph.D., a detailed design framework for building a national research participant group, called a cohort, of 1 million or more Americans to expand knowledge and practice of precision medicine.

NIH plans to move quickly to build the infrastructure so that participants can begin enrolling in the cohort in 2016, with a goal of enrolling at least 1 million participants in three to four years.

In order to advance that approach to medicine, President Barack Obama proposed the Precision Medicine Initiative, which aims 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. The initiative includes many components with efforts from across the federal government and was budgeted at $215 million in fiscal year 2016 by the president. NIH will lead efforts in cancer genomics, as well as the development of the participant cohort. Of the total proposed in FY16, $130 million was allocated to NIH to build the research cohort.

The report also proposes an innovative strategy to allow any person living in the U.S. to voluntarily enroll in the study directly or through participating healthcare provider organizations. Participants would volunteer to share core data including their electronic health records, health survey information and mobile health data on lifestyle habits and environmental exposures. They also would undergo a standard baseline exam for vital signs, medication assessment and past medical history and provide a blood sample. In return, participants will have access to their study results, along with aggregated results from all study participants, and will be provided with tools to make sense of the results.

NIH has appointed Josephine P. Briggs, M.D., as the interim director of the NIH Precision Medicine Initiative Cohort Program. Briggs, a nephrologist, is the director of the National Center for Complementary and Integrative Health. Her own research has focused on mechanisms of diabetic kidney disease. She brings extensive experience in oversight of clinical research to interim leadership of the program.

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