Precision Medicine Initiative Moves Forward

Sept. 18, 2015
The National Institutes of Health Advisory Committee to the Director (ACD) released a report laying out a blueprint for the Obama Administration’s precision medicine initiative (PMI), including the framework for building a large-scale, national research cohort of 1 million or more Americans.

The National Institutes of Health Advisory Committee to the Director (ACD) issued recommendations on Sept. 17 laying out a blueprint for the Obama Administration’s precision medicine initiative (PMI), including the framework for building a large-scale, national research cohort of 1 million or more Americans.

President Barack Obama announced the PMI back in January and in March, the National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D., formed the PMI Working Group of the ACD to develop a plan for creating and managing the PMI Cohort Program (PMI-CP). The initiative’s aim is to pioneer a new model of patient-powered research to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

The report drafted by the working group makes numerous recommendations on cohort assembly, participant engagement, data, biological specimens, policy and governance. The recommendations are based on a set of high-value scientific opportunities that were identified by the working group following extensive stakeholder engagement, including four public workshops and two requests for information, according to an NIH announcement.

In a statement on its website, the NIH says it 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.

“We have an incredible opportunity to advance research and make new medical breakthroughs through precision medicine, which tailors disease prevention and treatment to individuals based on genetics, environment and lifestyle,” Department of Health and Human Services Secretary Sylvia Burwell said in a statement.

The working group's report also proposes a strategy to allow any person living in the United States 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.

“Many factors have converged to make now the right time to begin this ambitious project,” Dr. Collins said. “Americans are engaging in improving their health and participating in health research more than ever before, electronic health records have been widely adopted, genomic analysis costs have dropped significantly, data science has become increasingly sophisticated and health technologies have become mobile. We have to seize this moment to invest in these promising scientific opportunities to help Americans live healthier lives.”

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