Clinical trial reporting rules being flouted

US Government enforcement improving compliance

SCIENCEINSIDER, Science News, 16 May 2023

The U.S. National Institutes of Health (NIH) has recently undertaken to ensure that the more than $6 billion in clinical trials it funds annually, along with their results, are visible to scientists, physicians, patients, and ultimately taxpayers. Transparency advocates say the tougher stance is beginning to pay off. For example, GAO also found that between July and November 2022, the agency brought 235 extramural researchers into compliance with registration and reporting requirements.

Under a 2007 law, sponsors running many clinical trials of drugs and devices—including those funded by NIH—are required to register them on within 21 days of enrolling the first volunteer. The results generally must be submitted to within 1 year of when key data are collected on the last participant. The law directs NIH to shut down funding to any institution whose researchers are not up to date.

But NIH has done little to enforce the requirements, even after it put in place a new policy in 2017 that expanded them to cover all NIH-funded trials and media reports began to throw a spotlight on problems.

As recently as August 2022, the U.S. Department of Health and Human Services’s Office of Inspector General found that just 35 of 72 NIH-funded clinical trials due to report their results in 2019 and 2020 had done so in a timely manner—and that 25 had not submitted them at all.

NIH has recently taken steps to bring those numbers up. They include having both the funding institute and the Office of Extramural Research contact tardy investigators to bring them into compliance. GAO, too, noted that extramural investigators are now required to show NIH proof of trial registration and results reporting before filing the annual progress reports necessary to receive their grant’s next year of funding.

For 2020-2022, 96% of 530 extramural trials required to report results have done so, although just 37% had met the 1-year deadline.

The GAO report also found that 16% to 18% of trials are registered late—a number that did not budge from 2019 through 2022. (The numbers are worse for pediatric trials, a recent study reported.) The tardy performances included NIH’s own institutes, led by the National Cancer Institute, where 81 trials were registered late in that period. Also, 18% of trials had not obtained informed consent from participants. This information is needed for many reasons, from making sure research groups don’t repeat the same trial to revealing failed trials that often aren’t published so others can steer away from those approaches.

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SOURCE: SCIENCEINSIDER, Science News, 16 May 2023

NIH toughens enforcement of delayed clinical trials reporting

By Meredith Wadman

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