The NIH has approved the framework to build a national research cohort of 1 million Americans, a key part of President Obama's Precision Medicine Initiative.

The NIH recently approved the framework for a key piece of President Obama's Precision Medicine Initiative: the Cohort Program (PMI-CP), which will enroll 1 million Americans in a long-term study. Volunteers will provide a broad range of information, from electronic health records to health data on environmental exposures and lifestyle habits. The framework was devised by a working group established by the NIH director, Francis Collins, MD, PhD, in March.

“Participants will have access to their study results, because people are interested in getting information about themselves,” said Kathy Hudson, PhD, the NIH deputy director for science, outreach, and policy and a co-chair of the working group, during a media teleconference in September. “We're hoping to tap a thread of altruism—essentially, people who want to contribute toward advancements in health and medicine.”

“The potential for progress has never been better, with Americans more engaged in their health, data science that's increasingly sophisticated, and health technologies becoming mobile,” Collins said. Far from being mere research subjects, recruits will be “true partners,” with a significant voice in the PMI-CP, he added.

When asked about the now-canceled National Children's Study—which was beset with problems, including management that lacked appropriate expertise, and an inability to evolve with new science and technology—Hudson noted that “strong scientific leadership, and a program that's flexible and nimble, should help ensure the PMI-CP's success.”

For instance, the working group recommends using a single Institutional Review Board to harmonize policies across the PMI-CP. In addition, during biospecimen collection, participants “should have the option to say, ‘I’d like to provide mine for unspecified secondary research; go off and do good things with it,'” Hudson added.

To ensure standardized information, biospecimens will be collected from participants and processed in compliance with the Clinical Laboratory Improvement Amendments (CLIA). “It's imperative that we have CLIA-certified data, because we may want to retrace participants with particular biomarkers and genotypes, and need to know that the samples can be mapped to the correct individuals,” said co-chair Richard Lifton, MD, PhD, a geneticist at Yale University in New Haven, CT.

As genomic analysis costs decrease and become “feasible at a scale of over 1 million people,” Lifton said, the PMI-CP hopes to obtain whole-genome sequences for all participants. This will provide opportunities to better understand the clinical consequences, if any, of mutations that genotyping—the program's starting point for collecting genetic information—might miss.

Mobile health technologies are also expected to play a prominent role, with the PMI-CP amassing data from smartphones and wearable devices such as fitness trackers. “We hope technology developers see our program as a great asset for finding out how their gadgets work in the real world,” said Collins. “There's a lot of mobile health activity right now, but little proof that using these devices actually improves health outcomes.”

Collins said he hopes the PMI-CP, which will begin enrollment in 2016, will have resources to track participants beyond the working group's recommended 10 years. “Consider the Framingham Heart Study, which started in 1948 and is still yielding fantastic data,” he said. “If we do it right, the same will be true for our initiative, with results that keep getting better.”

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