Johnson & Johnson says Yale School of Medicine to review requests for clinical drug data

Johnson & Johnson said Thursday that Yale School of Medicine's Open Data Access (YODA) Project will serve as an independent body to review requests from researchers and doctors seeking access to data from the company's clinical drug trials. The drugmaker noted that the deal marks the first collaboration "with a completely independent third party to review and make decisions regarding every request for clinical data."

Under the agreement, Johnson & Johnson said that YODA will review and make final decisions regarding all requests for clinical trial results, including clinical study reports and anonymised patient-level data. According to the company, the final decision on data sharing will be made by YODA, with Yale School of Medicine appointing an independent external panel of experts to help in some cases to assess requests.

Joanne Waldstreicher, Johnson & Johnson's chief medical officer, remarked that "sharing anonymised data from clinical trials is critical to advance public health," adding that the collaboration with YODA "represents a new standard for responsible, independent clinical data sharing." She said "we have nothing to hide and if new findings come out -- positive or negative -- all the better." The company also indicated that it plans to share data from clinical trials of its medical devices and consumer products, although this has not yet been finalised.

Harlan Krumholz, a professor at the Yale School of Medicine, who will lead the project, said the deal will open up a wealth of information about how drugs work, and their risks and benefits. "There are great insights that are residing within these data," Krumholz remarked, adding "it really will be game-changing."

Other drugmakers have made similar moves, with GlaxoSmithkline announcing in 2012 that it would allow greater access to clinical trial data to external researchers. Last year, Pfizer said it would broaden access to information from its clinical trials to independent researchers and to patients who take part in the studies.

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