Thursday, January 30, 2014

Johnson and Johnson To Share Raw Drug/Device Data Through Yale

A Johnson & Johnson subsidiary has entered into an agreement with Yale School of Medicine's Open Data Access (YODA) Project permitting YODA to review requests from investigators and physicians seeking access to anonymized clinical trials data relating to J&J pharmaceutical products. Aggregate and granular data are included, right down to anonymized individual patient and study-subject medical records. YODA will have authority to make final decisions regarding data sharing. J&J is also committed, in the future, to sharing its data on consumer products and medical devices. J&J's press release on the new initiative is here

This is a big deal. Independent researchers will be able to scour and re-crunch all the J&J data, looking for side-effects or sub-population effects of drugs, comparing previously unpublished data to data from outside sources, and so on. 

What's particularly novel here is that J&J has given up control of its data to the Yale group. Yale can decide to release data to researchers even if they anticipate findings that are negative for J&J. In contrast, GlaxoSmithKline has a limited data-sharing plan controlled by the firm. Requests that they deny are sent to arbitration. The J&J/YODA deal--struck between Harvard med-school classmates Harlan Krumholz of YODA and J&J chief medical officer Joanne Waldstreicher--is considerably more open. 

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