A team of experts participating in precision medicine and large clinical research studies is interested in public input from the stakeholder community in developing the Precision Medicine Initiative. The group of experts and the stakeholder community will help define what can be learned from a study of this scale and scope and what success will look like five and ten years out.
Formed as a Working Group of the Advisory Committee to the NIH Director, the team of experts will deliver a preliminary report in September 2015 to provide information on how individual differences play a role in health with the goal to enable better prevention and treatment strategies tailored for each person.
The Co-Chairs for the Working Group includes:
- Richard Lifton, M.D. PhD, Chair Department of Genetics Professor of Medicine, Founder and Executive Director, Yale Center for Genomic Analysis
- Bray Patrick-Lake M.F.S. Director of Stakeholder Engagement, Clinical Trial Transformation Initiative, Duke University
- Kathy Hudson, PhD, Deputy Director of Science, Outreach, and Policy at NIH
President Obama launched the Precision Medicine initiative www.nih.gov/precisionmedicine last January and called for initial funding of $215 million in his FY 2016 budget:
- $130 million would be used to begin 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
- $70 million would go to the National Cancer Institute to scale up efforts to identify genomic drivers in cancer and apply that knowledge to develop more effective approaches to cancer treatment
- $10 million would go to FDA to acquire additional expertise and advance the development of high quality curated databases to support the regulatory structure needed to advance innovation in precision medicine
- $5 million would go to ONC to support the development of interoperability standards and requirements to address privacy to enable the secure exchange of data across systems.
NIH held a workshop in February to discuss topics related to precision medicine such as privacy, EHRs mobile health technologies, existing research cohorts, participant preference, and inclusion of minority and underserved populations.
The working group also includes ex-officio members from the Department of Defense (DOD), Veterans Administration (VA), FDA, National Coordinator at HHS, and the White House Office of Science and Technology Policy.