Analysis Reveals Incomplete and Untimely Clinical Trial Results in European Registry
A recent analysis indicates that results for less than half of the clinical studies registered in a key European database were reported within the stipulated timeframe. Furthermore, complete results were fully disclosed for only 42% of these trials. Despite high quality in registration data, researchers suggest that overall compliance with legal reporting requirements is weak, citing a lack of regulatory oversight.
A new analysis has raised concerns regarding clinical trial transparency in Europe, finding that results for less than half of the studies registered in a prominent European database were reported within the required period. The analysis also revealed that complete results were fully reported for only 42% of the studies.
The findings were based on an examination of 234 clinical trials for which results were expected to be disclosed. While the quality of the registration data was high, with over 99% of expected data present, researchers concluded that compliance with legal reporting requirements was weak.
The authors of the analysis contended that regulatory oversight is lacking, stating that European Union and member state regulators have not delivered on promises of "high levels of transparency never seen before for clinical trials." This analysis was recently posted on the medRxiv preprint server, which hosts unpublished research that has not yet undergone peer review.
(Source: STAT News)
