NIH funds informatics projects for small trials

By Phil Taylor

- Last updated on GMT

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The US National Institutes of Health has awarded a series of new contracts to try to stimulate greater use of sophisticated data management software in small to medium-sized clinical trials.

While informatic approaches to data management are routinely used in large-scale studies – often out of necessity given the volume of data generated – that is not always the case in smaller studies, in some cases because of the cost of commercial software packages.

And while a number of groups have started work on open-source software, their efforts have been fragmented. Through its Clinical and Translational Science Awards (CTSA) consortium, the NIH is hoping to pull these strands together.

The NIH has awarded three two-year contracts – each worth up to $4m – for IT systems that “store, process and facilitate the exchange of information​” and will help “enable the translation of rapidly evolving information developed in basic biomedical research into treatments and strategies to improve human health.​”

Critically, any software developed from the new NIH-backed programmes will be made freely available to biomedical researchers, educators and institutions in the non-profit sector.

While commercial data capture and trial management systems are available, a review published last year in the journal PLoS Medicine​ (March 4, 2008) concluded that “clinical trials–related software can be prohibitively expensive, especially for individual researchers, or groups based in developing countries​.”

The recipients of the grants are Case Western Reserve University in Cleveland, the University of Washington in Seattle, and Vanderbilt University in Nashville.

Case Western’s project focuses on using clinical, physiological and genomic data to explore how variations in physiology vary in individuals with different genetic profiles and disease risk factors. Washington is looking at ways to help researchers across different institutions share datasets in designing clinical studies. Finally, Vanderbilt is developing new methods and tools to support scientific research data capture and dissemination via secure web-based applications.

The universities will coordinate the activities of other institutions, and all contribute to the CTSA consortium.

"These projects, which will build on the existing strong informatics expertise at the institutions, will promote new ways in which to enable researchers to collaborate and communicate across the CTSA consortium and with other partners in their research​," said Dr. Barbara Alving, director of the National Center for Research Services.

"The projects are one important part of a larger effort to achieve the potential of clinical and translational science and reduce the time it takes to develop new treatments for disease.​"

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