The NIH has selected Vanderbilt University and Verily (formerly Google Life Sciences) to launch the first “pilot” phase of the Precision Medicine Initiative (PMI)'s planned research cohort of 1 million or more Americans from which to glean health and wellness data.

The Vanderbilt-Verily partnership was announced today by President Obama's administration among actions intended to advance its $200-million-plus PMI, on the occasion of a White House summit promoting the effort, which is expected to attract 170 professionals.

Vanderbilt and Verily will help researchers establish and test methods and technologies for enabling direct recruitment of participants, as well as sharing of data with researchers.

During a briefing with reporters on the PMI actions, NIH Director Francis S. Collins, M.D., Ph.D. said, “The goal—although it is a very tentative goal—is to have 50,000 of those folks [participants] enrolled by the end of this calendar year.” This would be through direct recruitment, and among the 79,000 participants envisioned in 2016.

He said Vanderbilt and Verily will explore optimal approaches and systems for engaging and enrolling participants in the cohort.

“The early parts of this pilot are really going to test out what kind of approaches are in fact received well by participants,” Dr. Collins added. “They will be our test opportunities to tell us whether in fact they’re getting the kind of information they need to decide whether or not they want to participate, getting the kind of information to explain what sorts of things they would need to be able to do in order to be a participant, and also to find out from them what kind of information they want to get back, how often they want to be contacted.”

All that information is going to be derived over the next few months. Once that information is at hand, according to Dr. Collins, the cohort can be scaled up, with the goal of enrolling at least 1 million participants by 2019.

“This pilot approach will help us learn how to create durable relationships with volunteers, who are partners in the research process, who will lay the foundation for a democratized, transformative research environment,” he said.

The administration’s other PMI actions announced today:

  • NIH will work with the U.S. Health Resources and Services Administration to launch partnerships with several health centers to develop, pilot, and refine approaches to drawing underrepresented individuals, families, and communities to the cohort.
  • NIH will also work with the Office of the National Coordinator for Health IT (ONC) to develop open standards with electronic health record developers Allscripts, athenahealth, Cerner, drchrono, Epic, and Mckesson—a program dubbed “Sync for Science.”
  • ONC will work with the National Institute of Standards and Technology (NIST) to develop by December a precision medicine–specific guide to the NIST Cybersecurity Framework.
  • The White House released for public comment a draft of its Data Security Policy Principles and Framework for PMI. A final document is set to be released this spring.
  • The Department of Veterans Affairs is partnering with the Department of Defense to facilitate enrollment of active duty men and women into the VA’s Million Veteran Program (MVP), a research cohort with more than 450,000 veteran enrollees.
  • The FDA will use its new precisionFDA cloud-based platform for next-generation sequencing assay evaluation in its first “challenge,” aimed at encouraging genomics researchers to advance quality standards and achieve more consistent and accurate DNA test results.
  • The Office for Civil Rights has issued additional guidance on individuals’ rights to access their health information under the Health Insurance Portability and Accountability Act (HIPAA).

Obama proposed PMI last year, and won funding as part of the budget deal last December. Three months earlier, Dr. Collins accepted an advisory panel’s recommendations for implementing the cohort. According to the administration, more than 40 private-sector organizations are making commitments that will accelerate precision medicine.

One of the latest commitments was announced today by the New York Genome Center (NYGC), a nonprofit academic-medical-industry consortium, and IBM. They said they will partner to create a comprehensive and open repository of genetic data to accelerate cancer research and scale access to precision medicine using Watson, IBM’s cognitive computing platform.

In the project’s first phase, NYGC and IBM said, they will examine genetic information from 200 cancer patients to compare how different types of sequencing might impact possible treatment options.

“Our vision is to create a comprehensive cancer data repository that combines whole genome, exome, targeted panel, and phenotypic data in an open platform that will empower researchers and clinicians,” stated Robert B. Darnell, M.D., Ph.D., NYGC’s founding director and CEO.

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