In Stunning Win For Open Science, Johnson & Johnson Decides To Release Its Clinical Trial Data To Researchers by Matthew Herper.
From the post:
Drug companies tend to be secretive, to say the least, about studies of their medicines. For years, negative trials would not even be published. Except for the U.S. Food and Drug Administration, nobody got to look at the raw information behind those studies. The medical data behind important drugs, devices, and other products was kept shrouded.
Today, Johnson & Johnson is taking a major step toward changing that, not only for drugs like the blood thinner Xarelto or prostate cancer pill Zytiga but also for the artificial hips and knees made for its orthopedics division or even consumer products. “You want to know about Listerine trials? They’ll have it,” says Harlan Krumholz of Yale University, who is overseeing the group that will release the data to researchers.
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Here’s how the process will work: J&J has enlisted The Yale School of Medicine’s Open Data Access Project (YODA) to review requests from physicians to obtain data from J&J products. Initially, this will only include products from the drug division, but it will expand to include devices and consumer products. If YODA approves a request, raw, anonymized data will be provided to the physician. That includes not just the results of a study, but the results collected for each patient who volunteered for it with identifying information removed. That will allow researchers to re-analyze or combine that data in ways that would not have been previously possible.
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Scientists can make a request for data on J&J drugs by going to www.clinicaltrialstudytransparency.com.
The ability to “…re-analyze or combine that data in ways that would not have been previously possible…” is the public benefit of Johnson & Johnson’s sharing of data.
With any luck, this will be the start of a general trend among drug companies.
Mappings of the semantics of such data sets should be contributed back to the Yale School of Medicine’s Open Data Access Project (YODA), to further enhance re-use of these data sets.