Numerous institutions have failed to post results to ClinicalTrials.gov, but neither the US National Institutes of Health nor the Food and Drug Administration has done much to enforce the law, Science reports.
Beginning in 2017, new rules went into effect that required clinical trial sponsors to register trials at ClinicalTrials.gov within 21 days of enrolling their first patients and to post their results within one year of collecting data from the last patient. The new rules also better enabled enforcement of the regulations, as Nature News reported at the time. The rules aimed to ensure that all clinical trial results, whether they were encouraging or disappointing, are reported.
But according to an analysis by Science, many institutes — including NIH itself — have done a poor job of uploading results in a timely fashion. It reports that less than 45 percent of the more than 4,700 clinical trials it analyzed reported their results to ClinicalTrials.gov either early or by the one-year deadline. About 24 percent were reported late and almost 32 percent were not reported at all.
At the same time, Science found that NIH has not cut off grants to any offending institutions, as the rules enabled it to do, and that FDA has not fined anyone for failing to post results.
"Reporting to ClinicalTrials.gov is frequently seen by sponsors, funders, and trialists as an annoying administrative and perhaps legal burden, not a scientific imperative," Brigham and Women's Hospital's Deborah Zarin, who headed ClinicalTrials.gov between 2005 and 2018, tells Science. "Human nature being what it is, people follow the requirements when forced to do so."