IOM to address how best to share clinical trial data

The Institute of Medicine will weigh in on the knotty issue of clinical trial data sharing when it releases its preliminary guiding principles Wednesday. Experts hope they will address key concerns facing academic researchers and manufacturers, including increasing transparency to build public trust in research results.

Access to data traditionally has been considered proprietary. Scientists attempting to review small, often unpublished, studies, especially those from the pharmaceutical industry, have not been able to gain access to the data. But efforts to make data more readily available have been growing.

“How should data be shared? Who is responsible? How will it be financed? How will patient privacy be maintained?” asked Dr. Joseph Ross, co-principal investigator for the Yale University Open Data Access project. He is optimistic the IOM report will help to address these concerns. “Once a drug is approved by the FDA, all the clinical trial data used to support that approval should be available publicly so that other independent researchers can use it for analysis,” said Dr. Michael Carome, director of the Health Research Group for Public Citizen. “Such transparency and availability will help build confidence in research to support the approval of drugs and medical devices.”

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