FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Half of EU Clinical Trial Results Are Not Reported

Sept. 17, 2018
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Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far, BMJ reported Wednesday.

The analysis found trial sponsors only reported about 51 percent of 7,274 clinical trial results since publication of the European Commission’s guidelines in 2014. Of these, 68 percent of trials with a commercial sponsor posted the results, while only 11 percent of non-sponsored trials shared theirs.

The study, led by University of Oxford researcher Ben Goldacre, found that 32 major universities did not report results for any trials they sponsored. Eleven drugmakers whose trial data the researchers analyzed reported all the trials they sponsored, including Genentech, Gilead and Boehringer Ingelheim. On the other end of the spectrum, Eli Lilly reported only 52 percent of its trials.

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