NIH mulls “enforcement actions” for firms that miss trial result publication timelines

More data from US Government-funded drug trials are being posted online according to new analysis, but the NIH says additional transparency measures – including enforcement actions – are needed.

The analysis, which was published in the British Medical Journal, looked at the publication of results from clinical trials funded by the US National Institutes of Health (NIH) over the past three years.

The key finding is that, while in 2020 only 28.6% (16) of trial results that were expected were submitted to ClinicalTrials.gov within the one year requirement, two years later that figure had increased to 45% (126).

In addition, the average number of days taken to report clinical trial results fell from 740 in 2020 to 400 days last year.

NIH deputy director of extramural research, Mike Lauer, said the improvement reflected efforts to make publicly funded drug research more transparent.

Enforcement actions

However, Lauer acknowledged there is more to do, suggesting firms involved with NIH-funded studies that do not publish results in a timely fashion may face sanctions.

“Clearly, we still need to improve, and we are committed to taking this challenge head on. Moving forward, you will see increased communication from us and, if needed, enforcement actions to get us to where we need to be.”

He also urged industry to take more responsibility for the publication of data from NIH-funded trials.

“First, if you receive a letter from us about a potentially non-compliant trial, be responsive. If you are an investigator and your trial has reached its primary completion date, submit your results to ClinicalTrials.gov as quickly as possible, ideally well before 365 days have passed.

“If you are an institutional leader, reach out to your faculty to impress upon them the importance of timely reporting and develop your own internal controls to make it easier for faculty to report results efficiently. With your help we can together assure a transparent and accountable clinical trials system.”

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