FDA Plays

[starbuxsux]

In Stunning Win For Open Science, Johnson & Johnson Decides To Release Its Clinical Trial Data To Researchers

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 JNJ -1.33% 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.

“We really wanted a broad approach to contributing to advancing medical science through all of our products that touch patients in different ways,” says Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. “Responsible sharing of clinical trial data advances science and medicine and is part of Johnson & Johnson’s commitment to the doctors, nurses, patients, mothers, and fathers and all others who use our products,” said Paul Stoffels, MD, J&J’s chief scientific officer, in a prepared statement.

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.

Waldstreicher admits that there will be “a bit of a learning process.” What, for instance, about data from trials for rare diseases, where it may be possible to figure out who the participants were? Or what if the data is held not by J&J, but by a partner? But she commits to trying to get the data released even in those cases if it is feasible.

Krumholz, who heads the YODA Project, says that he hopes J&J’s leadership will set “a remarkable standard for data sharing that will ripple not only through industry but also through academia.” He hopes it will help the company by teaching them more about their drugs. “They’re going to get peoplelooking at their data for free.”

This is not the first time that a drug company has offered to make this type of raw, or patient-level, data public. GlaxoSmithKline GSK -2.29% has made big promises about doing something similar, although it is choosing its own review board to get data released. Medtronic MDT -1.28% worked on a similar project with YODA, but only for a single, controversial product, the bone drug INFUSE.

Scientists can make a request for data on J&J drugs by going to www.clinicaltrialstudytransparency.com.

http://health.einnews.com/article/188032375