Agency says it has brought more than 200 tardy investigators into compliance since July 2022
Last year, the U.S. National Institutes of Health (NIH) delivered a stern warning to two in-house clinical researchers who had broken an important rule. They had failed to submit the results of two clinical trials they had overseen to ClinicalTrials.gov, a database meant to inform the public about human studies and their results. The reporting requirement has often been ignored, but this time the agency took an unprecedented step: It told the scientists it wouldn’t approve any more of their research until they fell in line.
It is absolutely fantastic to see the NIH follow up on its recent actions with the recalcitrant reporting of the results of funded clinical trials with stern warnings and actions with regard to funded trials that have failed to report the results of that trial. It is worthwhile noting that the NIH has had a policy in this regard for some time and this has been the law in the United States as well. Consequently, they are just implementing what they should have been doing already. Other jurisdictions and funding bodies would do well to emulate this behaviour.
The episode, described in a Government Accountability Office (GAO) report published in April, adds to other, systematic changes 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.
“We really do like some of the changes that the NIH has made. We think that’s a really great start,” says Navya Dasari, a lawyer who until recently headed efforts by the nonprofit lobbying group Universities Allied for Essential Medicines to increase transparency of clinical trial results.
Candice Wright, lead author of the GAO report, says NIH “should be ensuring compliance [with the policy]. It exists for a reason.”
Under a 2007 law, sponsors running many clinical trials of drugs and devices—including those funded by NIH—are required to register them on ClinicalTrials.gov within 21 days of enrolling the first volunteer. The results generally must be submitted to ClinicalTrials.gov 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.