STAT+: European regulators take steps to bolster clinical trial transparency

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.In a boost for greater clinical trial transparency, the European Medicines Agency (EMA) is taking what consumer advocacy groups are calling unexpectedly “rapid action” to ensure that study results are made public as required by law. The move comes after a recent analysis found 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%. The researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking. This was the first analysis to examine the Clinical Trial Information System (CTIS) that was created in 2022 as part of an effort to enhance transparency across the European Union and the European Economic Area. The registry contains more than 8,400 mid- and late-stage trials and, in the coming months and years, sponsors will be legally required to make results public. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe