STAT+: European regulators take steps to bolster clinical trial transparency
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- European Medicines Agency is taking what consumer advocacy groups call "rapid action" to ensure clinical trial results are made public as required by EU law
- A first-of-its-kind analysis of the Clinical Trial Information System (CTIS) found complete results were fully reported for only 42% of registered trials, with results for less than half posted within the required timeframe
- The CTIS, created in 2022 to enhance transparency across the EU and European Economic Area, currently contains more than 8,400 mid- and late-stage trials
- Researchers behind the audit concluded that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking
- Sponsors will be legally required to make results public in the coming months and years as the EMA ramps up enforcement
Why it matters: For the sponsors behind the 8,400+ mid- and late-stage trials already in the CTIS, the EMA's enforcement push converts a loosely enforced paper rule into an active regulatory target. With only 42% of trials fully reporting results today, the gap between current practice and legal requirements represents concrete compliance exposure for drug companies as deadlines begin to bite.
