FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Most European Academic Centers Fail to Report Trials, Study Finds

May 10, 2019
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More than four-fifths of European clinical trials are not complying with EU transparency laws, an analysis by a group of nonprofits has found.

Researchers at TranspariMED, Buko Pharma-Kampagne, Test Aankoop and Health Action International analyzed trials run by 30 different universities in Europe and the UK and found that 778 trials were “verifiably missing data” that was supposed to be reported to European regulators. Under European Union rules introduced in July 2014, every clinical trial registered in the EU must post summary results within 12 months of a trial’s completion—or within six months in the case of pediatric trials.

Fourteen universities—located in France, Italy, Norway and Sweden—have failed to post a single clinical trial result, the report shows, and 13 others “perform weakly,” with reporting rates ranging from 2 percent to 33 percent,” the researchers found.

The UK proved to be the bright spot in the study: Oxford University, University College London and King’s College London all have posted more than 80 percent of their trial results.

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