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Add the Missing Data

A federal judge has ruled that drug companies, device manufacturers, and universities need to provide missing clinical data from hundreds of trials to, ScienceInsider reports. It adds that the judge found that US agencies including the National Institutes of Health and the Food and Drug Administration have been misinterpreting a law requiring them to collect and post such data.

Stat News reported in 2015 that many top research institutes were late in reporting their clinical trials results to the database or didn't report them at all, and Science additionally reported this year that FDA has never fined a trial sponsor for failing to disclose those results and NIH has never publicly named or taken grant funding away from an institute that did not disclose results.

This new ruling, Stat News says, will make it more difficult for trial sponsors to keep unfavorable trial results out of the public eye. "This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA," Christopher Morten from New York University's Law & Policy Clinic, who represented the plaintiffs, tells Stat News.

The lawsuit was brought by Peter Lurie, a former associate FDA commissioner, and Charles Seife, a New York University journalism professor.