Infographic – Mediocre ClinicalTrials.gov Report Rates

Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Nicholas J DeVito, Seb Bacon, Ben Goldacre. The Lancet. 17 Jan. 2020. https://doi.org/10.1016/S0140-6736(19)33220-9. Click on image for full size view.

18 Jan. 2020. New data show most sponsors of clinical trials are not reporting their results on time to a U.S. government web site as required by law. A team from University of Oxford in the U.K. describe their findings in yesterday’s issue of the journal The Lancet (registration required), which provide the data for this weekend’s infographic.

The Food and Drug Administration Amendments Act requires clinical trial sponsors to report their results to the web site ClinicalTrials.gov, maintained by National Library of Medicine under National Institutes of Health, within one year of completion. But as Oxford’s Nicholas Devito, Seb Bacon, and Ben Goldacre discovered, meeting that requirement is more the exception than the rule.

From the period March 2018 to September 2019, say the authors, 4,209 clinical studies were required to report their findings. Only about 4 in 10 clinical trials, 1,722 or 41 percent, of that total filed their results within one year. And less than two in three, 2,686 or 64 percent, reported any results at all.

Industry-sponsored trials had the highest compliance rate, with half (50%) of its 1,837 clinical studies reported on time, compared to about one-third (34%) of non-industry sponsors — e.g., universities and research institutes — and three in 10 (31%) for U.S. government studies. While clinical trials sponsored by the U.S. government accounted for only about five percent of the total due to report, their rate for any reports, on time or not, reached 74 percent, compared to 65 percent for industry and 62 percent for non-industry sponsors.

More from Science & Enterprise:

• Guidelines Proposed for Complex Clinical Trials
• Safety Reports Analyzed with A.I. to Reduce Medical Errors
• Real-World Evidence Assessed for Cancer Drug Trials

*     *     *