A working group of the Advisory Committee to the Director of the National Institutes of Health (NIH) presented its recommendations to NIH Director Francis S. Collins, MD, PhD, on how best to implement the Precision Medicine Initiative, a venture announced earlier this year by President Obama.

During the briefing, Collins announced his intent to expedite implementation of the recommendations, in addition to appointing the first director of the initiative soon. Josephine P. Briggs, MD, currently the director of NIH’s National Center for Complementary and Integrative Health, will serve as the interim director of the Initiative’s Cohort Program.

“We’re ready to try some new experiments here,” says Collins, of the Initiative.

Intended to lead a 'new era of medicine,’ the Precision Medicine Initiative will generate medical advances based on more specific data concerning the molecular and environmental factors that impact health, disease onset and progression, and treatments. In the Initiative’s Cohort Program, a national research participant group will serve as the foundation of the Initiative, involving one million Americans in research that will result in innovations in precision medicine. According to Collins, the NIH hopes to begin enrollment in 2016, with the goal of one million participants in three to four years.

In order to achieve such numbers, the Working Group recommends that both health care professionals and systems encourage patients to participate. The report also suggests that the Initiative allow voluntary enrollment for any person in the U.S., offering participants access to the study results in return.

The report also recommended:

• Direct participant recruitment, as well as collaboration with healthcare provider organizations
• Development of an interactive and proactive participation model that encourages engagement from participants
• Use of a core data set, aligned with other data sets where possible
• Initial focus on the collection of blood specimens using a standard CLIA compliant procedure
• Development of the necessary policies to address research, data security and privacy, and access and interoperability of electronic health records, among others, particularly those focused on participant engagement

"This effort has the potential to accelerate knowledge generation in medicine by creating a platform that engages people as active data donors – and meaningful contributors to the enterprise," states Harlan Krumholz, MD, SM, FACC, a member of the Advisory Committee.

ACC Advocacy will continue to follow the Precision Medicine Initiative as it develops.

Keywords: Advisory Committees, Electronic Health Records, National Institutes of Health (U.S.), Patient Compliance, Privacy

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