In DepthClinical Trials

European law could boost clinical trials reporting

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Science  16 Jul 2021:
Vol. 373, Issue 6552, pp. 268
DOI: 10.1126/science.373.6552.268

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Summary

The global pandemic has turned a spotlight on clinical trials, which test thousands of drugs and therapies each year. In Europe, however, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. A total of 3846 European trials—nearly 28% of 13,874 completed trials in the EU Clinical Trials Register on 1 July—had not posted their results on the register, according to the latest data from the EU Trials Tracker, set up by U.K. researchers in 2018 to expose lax reporting. Public research hospitals and universities, not drugmakers, are responsible for most of the lapses, which appear to violate European rules that require sponsors to post their results within 1 year of a trial's conclusion. Experts say undisclosed results can lead to wasted efforts and missed signs of drugs' potential harms. But Europe is getting more serious about enforcing the reporting requirements. The European Medicines Agency has stepped up reminders to trial leaders, and a new trial registry is set to come online in January 2022, when national regulators will also gain more power to enforce the rules.

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