European Regulators Take Steps to Bolster Clinical Trial Transparency
The European Medicines Agency (EMA) is taking 'rapid action' to ensure that study results are made public as required by law, following 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.[5280784]
This move comes after a review found overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.[5280784]
The analysis of the Clinical Trial Information System (CTIS) was the first to examine the database, which contains more than 8,400 mid- and late-stage trials.[5280784]
In related news, the White House and the Department of Health and Human Services will convene experts to discuss standards for clinical artificial intelligence.[5259971]
The goal of this discussion is to arrive at a consensus set of principles for benchmarking and evaluating clinical AI.[5259971]