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HOSPITAL REPORT

The premier resource for hospital professionals from Relias Media, the trusted source for healthcare information and continuing education.

Another pharma company opens door on trial data

Following the cues of companies such as Pfizer and GlaxoSmithKline, Johnson & Johnson announced that it will make clinical trial data available to academics and outside researchers. But J&J is taking it a step further and by giving free and clear data access through Yale University’s Open Data Access Project (YODA).

Over the last several months, I’ve written quite a bit about the push for drug companies to make their clinical trial data available to the public, or at least to outside researchers. Despite requirements from the FDA to publish clinical trial data on ClinicalTrials.gov, research has shown that trial results go unpublished for years after completion. Groups of academics and researchers are calling for companies to publish lost or abandoned trial data, or face publication by an outside group.

But, as always, there’s a bit of a catch: Researchers must apply to YODA, and an approval board will review the data requests (with no J&J advisors on the board). If approved, researcher will have full access to J&J data. Both Pfizer and GSK also review data requests from researchers, though the data released is more limited.

“We have nothing to hide and if new findings come out -- positive or negative -- all the better,” Joanne Waldstreicher, J&J’s chief medical officer, told Businessweek. It will be interesting to see how many more pharma companies will make the same decision.