Colorful pills laying on a calendar.

Clinical trial registry errors undermine transparency

A lack of comprehension among some researchers about how to use ClinicalTrials.gov may be hindering public access to trial information and holding up drug study results.

By Catherine Offord, The Scientist

Confusion about terminology on the world’s largest clinical trials registry may be delaying the release of drug trial results and undermining rules designed to promote transparency, an investigation by The Scientist has found.

Key study dates and other information are entered into the ClinicalTrials.gov database by trial researchers or sponsors, and are used by US science and regulatory agencies to determine legal deadlines by which results must be reported. The rules are supposed to ensure timely public access to findings about a potential therapy’s harms and benefits, as well as provide the scientific community with an up-to-date picture of the status of clinical research.

But neither the agencies nor staff overseeing the database routinely monitor individual trial records for veracity, instead relying on the person in charge of a given record to correctly declare information such as when a study ends and how many people were enrolled.

Our examination of a subset of COVID-19 trial records shows that some of this information can be wildly inaccurate. Specifically, listed end dates for studies can be wrong by months or even years—meaning that reporting deadlines based on those dates are essentially arbitrary. The findings, which in some cases appear to reflect a lack of understanding among researchers about how to use the database, imply that many more studies than previously appreciated could be in violation of US reporting regulations. Read more …