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YODA knows: J&J gives drug info
to Yale Open Data Access

In a "stunning win for open science," Yale has struck a deal to acquire all of Johnson & Johnson's clinical drug trial results, and to make them available to researchers worldwide.

"They have agreed to set their raw data free," says School of Medicine professor Harlan Krumholz ’80 in an e-mail. "We want to usher in a new era of science—one where data assets can be fully harvested—results can be reproduced—new insights can be gleaned."

Krumholz heads the Yale University Open Data Access project, or YODA. Without identifying patients, J&J will turn over all of the results of all of its pharmaceutical clinical trials—including studies that were never published. Scientists from all over the world can then request access. YODA will have sole authority to decide who gets access, based on "principles of scientific review" that Yale and the company will develop jointly, according to a Yale news release.

The agreement, which grew from Krumholz's friendship with J&J's chief medical officer, sets a new standard for transparency in a pharmaceutical industry often criticized for cherry-picking data. By giving Yale control over who can see the data, Johnson & Johnson avoids "a fox-watching-the-henhouse ethical problem," the website Xconomy notes.

"This is also crowdsourcing of science," Krumholz says in his e-mail. "By allowing any scientist in the world to work on these data, we will have insights that otherwise would not have been produced—and everyone, including the company, will benefit."

What's more, J&J is releasing trial results that have never been published. Overall, only about half the studies funded by the National Institutes for Health find their way to publication, Krumholz and others have reported.

"If you are doing a systematic review" of a drug's safety or effectiveness, he writes, "you can now do it with all the evidence. In the past (er, present) evidence-based medicine is based on only the evidence that has been placed in public view."

Not surprisingly, Krumholz tells Bloomberg BusinessWeek that he approached other drugmakers, who were “are reluctant to give up the control.” Now, he hopes, some will follow J&J's lead.

YODA, established in 2011, is part of the Center for Outcomes Research and Evaluation, which Krumholz also directs. The overall goal is to provide better information to doctors and patients about what medical treatments and practices actually work.

Filed under Harlan Krumholz, YODA, open science, Johnson & Johnson
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