NIH-Led Team To Help Guide Path of Precision Medicine Initiative

March 31, 2015 in News

On Monday, NIH announced a team of experts who will gather public input on topics, such as electronic health records and privacy, to help set the path for President Obama’s Precision Medicine initiative, Health Data Management reports (Slabodkin, Health Data Management, 3/31).

Background on Precision Medicine Initiative

In February, President Obama in his fiscal year 2016 budget proposal asked Congress for $215 million in funding for a personalized medicine initiative that centers around the creation of a massive database containing the genetic data of at least one million volunteer participants (iHealthBeat, 2/3).

Of the $215 million in funding:

  • $131 million would go toward NIH to recruit at least one million volunteers and analyze their full genetic makeups, as well as expand clinical trials for possible cancer medications;
  • $70 million would go toward NIH’s National Cancer Institute to further study genetic causes of cancers and use study findings to assist with drug development;
  • $10 million would go toward FDA to develop databases to help the agency create the regulatory structure for evaluating precision medicine advances; and
  • $5 million would go toward the Office of the National Coordinator for Health IT to help develop interoperability standards and policies to address privacy issues and help with secure data exchange across various systems.

NIH Director Francis Collins said the short-term goal of the initiative would be to develop additional and improved cancer treatments. He attributed the initial focus on cancer to researchers already making strides in the area and because of the lethal nature of the disease. Collins said that in the long-term, the initiative would apply the lessons learned to develop personalized treatments for other diseases.

He noted that the project is made feasible because the cost of genetic research and storing large amounts of data has fallen and the growing use of electronic health records and mobile technologies are making it easier to share data (iHealthBeat, 1/30).

NIH Working Group Details

According to Health Data Management, the 16-member group created by NIH will:

  • Determine what can be learned from a study of this size;
  • Identify issues that will need to be addressed as part of the study’s design; and
  • Consider what success would look like five and 10 years after initiation (Health Data Management, 3/31).

The working group will be co-chaired by three industry stakeholders:

  • Bray Patrick-Lake, director of stakeholder engagement for Duke University’s Clinical Trial Transformation Initiative;
  • Kathy Hudson, deputy director of science, outreach and policy at NIH; and
  • Richard Lifton, chair of the Department of Genetics at Yale University School Medicine and executive director of the Yale Center for Genomic Analysis (Keshavan, MedCity News, 3/30).

The group also includes ex-officio members from:

  • The Department of Defense;
  • The Department of Veterans Affairs;
  • FDA;
  • ONC; and
  • The White House Office of Science and Technology Policy (Health Data Management, 3/31).

Other group members represent the private sector (MedCity News, 3/30).

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