STAT+: A key European clinical trial registry lacks complete and timely results, an analysis finds
Article excerpt
Less than half of clinical trials registered in a major European database have reported their results within the legally required timeframe, according to a new analysis. The finding raises questions about transparency and accountability in European medical research, where regulators have set deadlines for trial sponsors to post outcomes. The analysis examined a key registry used across the continent and found persistent gaps in compliance. The results suggest that patients, doctors, and researchers lack timely access to crucial data about drug safety and efficacy that could influence treatment decisions and future studies.
Amid ongoing concern about clinical trial transparency, a new analysis found that results for less than half of the studies registered in a key European database were reported within the required time frame and complete results were fully reported for only 42%.
While the quality of the registration data was high overall, more than 99% of expected data was found in the 234 clinical trials for which results were supposed to have been disclosed, the researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.
European Union and member state regulators “have so far not delivered the promised ‘high levels of transparency never seen before for clinical trials,’” the authors wrote in their analysis. It was recently posted on the medRxiv preprint server, which displays unpublished research that has not yet been peer reviewed.
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