Thursday, October 31, 2013

AllTrials - The Harvard Way

Report Proposes Ways to Expand Access to Clinical Trial Data

Researchers from Harvard, together with members of a group created by the Multi-Regional Clinical Trials Center, released a report last week that proposed ways to expand access to clinical trial data.

The report--published online in The New England Journal of Medicine--outlined the possible benefits and risks, ethical and legal issues, and logistical questions associated with expanding access to participant-level data, which have, in the past, been considered confidential by the Food and Drug Administration, which regulates clinical trials of drugs conducted in the US.

Addressing concerns about sponsor-supported results, the authors stated that expanded access to clinical data could allow for a greater scientific innovation and a more accurate representation of a product’s safeness and effectiveness.

“Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data,” said Michelle M. Mello, a professor at Harvard School of Public Health and lead author of the report, in a press release.

While Mello emphasized the importance of providing independent scientists with access to clinical trial data, she also cautioned against the risk of revealing participants’ identities and providing too much information, which might strain trial sponsors.

“The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants’ privacy, avoiding ‘junk science,’ and minimizing burdens on trial sponsors?” Mello said in the release.

The report also discussed current initiatives to expand data access. For instance, the European Medicines Agency recently announced that it will start providing participant-level data that is submitted for regulatory purposes.

The authors recommended that new regulations targeted at expanding data sharing should be applied to trials of all approved prescription drugs, medical devices, and biologics in a way that preserves research participant privacy and treats sponsors and researchers “evenhandedly.”

Although the report does not come to a conclusion about how access to data should be expanded, it emphasizes that the expanded access to data is a question of how the transparency should be achieved, not whether or not it will.

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