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NIH Opens Discussion: How to Build a U.S. Health Research Database?

Xconomy National — 

National Institutes of Health director Francis Collins kicked off a two-day meeting in Bethesda, MD, this morning to discuss how to turn President Obama’s call for a national health research database into reality. The database, which NIH officials are calling the National Research Cohort, is one of two main thrusts of the administration’s precision medicine initiative.

The NRC is a long-term project with numerous technical, social, and scientific hurdles, but it will also face nearer-term financial and political pressures. Collins stressed to the gathered group the need to produce results to justify making annual requests to Congress, which controls the NIH’s purse strings.

Collins suggested one Congress-friendly aim of the project should be to help doctors make more informed diagnoses and prescriptions, “getting the right drug to the right patient at the right time.”

The White House has proposed $215 million for the initiative in the next fiscal year, which starts in October, and $130 million of that is earmarked to the NRC. There’s no guarantee that a Republican-led Congress will greenlight that request, but Collins said he was pleased so far with the way the initiative “has landed” among members of Congress. (And he noted that when President Obama floated the precision medicine idea in his Jan. 20 State of the Union speech, members of Congress from both sides of the aisle stood to applaud.)

How to integrate data from hundreds of thousands of people across potentially dozens of studies will be a massive technical challenge. There will be security and privacy concerns, too. Xconomy last week asked Jo Handelsman, associate director for science at the White House Office of Science and Technology Policy, how the NRC would handle privacy concerns and the inevitable resistance from some people to be included in a federally run database.

Some studies, or cohorts, have already gained broad consent from participants, said Handelsman, a former University of Wisconsin-Madison professor. She said she has read some of the consent agreements. “It would be fine to use [those] data for a larger cohort or the national project. Others would not, and those would either have to be re-consented by opt in or opt out,” she said. “That’s just going to vary across the whole country. We hope that’s something that the individual cohorts can work with their patients to coordinate.”

The momentum to build the NRC on top of existing cohorts seems inevitable, which rankled at least one participant at the meeting this morning. “I’d say we’re already starting with huge assumptions, and there are a lot reasons to consider alternatives,” said Regeneron Pharmaceuticals (NASDAQ: REGN) chief scientific officer George Yancopoulos. His company is working with the Pennsylvania health system Geisinger to build a 100,000 person genomic study, potentially one of the cohorts the NIH would like to incorporate into the national effort.

“The assumption is to start with existing cohorts, but a lot of us have dealt with similar problems in the past, and sometimes it’s more efficient and more powerful not to be saddled with [older] baggage,” Yancopoulos said.

The meeting continued today with presentations on the Veterans Administration comprehensive health database, on the collection of data from mobile devices, and on consent. On Thursday there will be a deeper dive into the information technology necessary for the cohort project.

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  • Linda Burk

    The article is rather informative. I am absolutely sure that idea with U.S. Health Research Database is great. Time will show what resuilts we will have. galdbladderhelp.com.

  • Jahid Hasan

    The NRC is a long-term project with numerous technical, social, and scientific hurdles, but it will also face nearer-term financial and political pressures. Collins stressed to the gathered group the need to produce results to justify making annual requests to Congress, which controls the NIH’s purse strings.