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Sept. 17— A blueprint to build a national research project involving at least a million people—the largest arm of the White House's Precision Medicine Initiative—was adopted by the NIH Sept. 17.
A report detailing the plan represents an important milestone in President Barack Obama's initiative, designed to transform medical practice by delivering more targeted treatments, said Francis S. Collins, director of the National Institutes of Health. It will allow the agency to move from the design phase to the implementation phase of the NIH Precision Medicine Initiative Cohort Program (PMI-CP), he said Sept. 17 during a press conference to release the report.
Adoption of the report's recommendations is “an inflection point to do something really historic,” Collins said. “This will set the tone for where we are deciding to go.”
The report, “The Precision Medicine Initiative Cohort Program—Building a Research Foundation for 21st Century Medicine,” is an effort by a working group of the NIH Advisory Committee to the Director, which developed the plan for creating and managing the million-person research cohort “to propel understanding of health and disease and set the foundation for a new way of doing research.” The advisory committee adopted the recommendations of the report, which Collins, in turn, accepted immediately.
The NIH plans to begin enrolling patients in the cohort in fiscal year 2016, which begins Oct. 1. The agency set a goal of enrolling at least 1 million participants in three to four years.
Obama unveiled the $215 million initiative during his State of the Union speech in January. Most of the funding— $130 million—is intended to support the million-person cohort addressed in the Sept. 17 report. The NIH appointed the working group in February.
The NIH's ability to carry out the million-person cohort rests upon Congress approving funds in the FY 2016 budget. Kathy Hudson, NIH deputy director for science, outreach, and policy, said during the press conference that she was encouraged that appropriations legislation drafted in both the House and Senate includes funding for the NIH Precision Medicine Initiative Cohort Program.
Precision medicine refers to a medical model that accounts for differences in people’s genes, environment and lifestyle to determine optimal treatment for individual patients.
The report said the PMI-CP will harness advances in genomic technologies, data collection and storage, computational analysis and mobile health applications that have developed over the last decade.
The recommendations cover cohort assembly, participant engagement, data, biological specimens, policy and governance.
Under the plan, any person living in the U.S. can voluntarily enroll in the study directly or through a participating health-care provider organization. Volunteers will share core data including their electronic health records, health survey information and mobile health data on lifestyle habits and environmental exposures. They also will undergo a standard baseline exam for vital signs, medication assessment and past medical history and provide a blood sample.
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. All of this will be accomplished with essential privacy and security safeguards.
The PMI-CP will be a highly interactive research model, the report said, where participants are partners in the development and implementation of the research who will have significant representation in governance and oversight. The report underscored the need to make participants an active part of the research process and not just subjects of an experiment.
• When selecting health-care providers to join the cohort, the NIH should consider the contribution of the provider to the overall diversity of the PMI cohort, the robustness of the electronic health records and expected length of follow-up for participants.
• The initial core data set acquired from all PMI cohort participants should be collected and stored centrally.
• Commonly used mobile health technologies should be selected early to gain experience in use and integration of these new modalities.
• The PMI-CP study should undergo review by a single institutional review board to reduce administrative burden and associated costs of the cohort, shorten study review time and harmonize inconsistent or conflicting policies.
• Safeguards need to be established against unintended release of data, along with penalties for the unauthorized re-identification of participants.
The report said the PMI-CP director should have “the institutional authority, professional expertise, and structural support to provide strong, credible, and effective leadership.” The director also should have the authority to set short- and long-term goals; develop solicitations and make award recommendations; and oversee data sharing, storage and use, it said.
Collins said a national search for a director was scheduled to begin Sept. 18. In the meantime, he has appointed Josephine P. Briggs, director of the National Center for Complementary and Integrative Health, as the interim director of the PMI-CP. Her own research has focused on mechanisms of diabetic kidney disease. She brings extensive experience in oversight of clinical research to interim leadership of this program.
Collins said the Precision Medicine Initiative is a long-term endeavor that will last at least 10 years.
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The working group report is available at http://acd.od.nih.gov/reports/DRAFT-PMI-WG-Report-9-11-2015-508.pdf.
A statement by Collins is at http://www.nih.gov/about/director/09172015-statement-PMI.htm.
Frequently asked questions about the PMI-CP are at http://www.nih.gov/precisionmedicine/faq-cohort.htm.
The NIH's PMI webpage is at http://www.nih.gov/precisionmedicine/.
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