Last year, the US National Institutes of Health (NIH) issued a stern warning to two clinical researchers who broke an important rule. They failed to submit the results of two clinical trials they oversaw to ClinicalTrials.gov, a database meant to inform the public about human studies and their results. The request to report has often been ignored, but this time the agency took an unprecedented step: It told scientists it would not approve any more of their research until it was in order.
After that warning and other agency actions, the couple complied, well past the one-year deadline.
The episode, described in a Government Accountability Office (GAO) report released in April, adds to other, systematic changes the NIH has recently made to ensure that the more than $6 billion in clinical trials it funds annually, along with their results, are visible for scientists, doctors, patients and ultimately taxpayers. Transparency advocates say the tougher stance is starting to pay off. For example, GAO also found that between July and November 2022, the agency brought 235 part-time researchers into compliance with registration and reporting requirements.
“We really like some of the changes NIH has made.” We think it’s a really great start,” says Navia Dasari, a lawyer who until recently led efforts by the nonprofit lobbying group Universities Allied for Essential Medicines to increase the transparency of clinical trial results.
Candice Wright, lead author of the GAO report, says the NIH “needs to ensure compliance.” [with the policy]. It exists for a reason.”
Under a 2007 law, sponsors conducting many clinical trials of drugs and devices — including those funded by the NIH — must register them on ClinicalTrials.gov within 21 days of enrolling the first volunteer. Results generally must be submitted to ClinicalTrials.gov within 1 year of the last participant’s key data being collected. The law directs the NIH to close funding to any institution whose researchers are not updated.
But the NIH did little to enforce the requirements, even after it introduced a new policy in 2017 that extended them to all NIH-funded trials, and media reports began shining a spotlight on the problems.
In August 2022, the US Department of Health and Human Services’ Office of Inspector General revealed that only 35 of 72 NIH-funded clinical trials that were scheduled to report their results in 2019 and 2020 had done so on time—and that he did not deliver 25 of them at all.
The NIH recently took steps to increase those numbers. They include both the funding institute and the Office of Extraordinary Research contacting overdue investigators to match them up. GAO also noted that part-time investigators are now required to show NIH proof of trial registration and results reporting before submitting the annual progress reports necessary to receive a grant for the next year of funding.
Michael Lauer, NIH’s head of extramural research, credited the agency’s changes when he provided updated numbers for the 530 extramural trials required to report results in 2020, 2021 and 2022. In a March blog post, he reported that 96% of these trial results reported at ClinicalTrials.gov. However, only 37% met the one-year deadline, and in 2022 the median delay was 400 days.
“Clearly, we still have room to improve, and we are committed to meeting this challenge,” Lauer wrote in a blog post. “Going forward, you will see increased communication with us and, if necessary, enforcement actions to get us where we need to be.”
NIH critics say the agency still needs to do more. The GAO report also found that 16% to 18% of trials were registered late — a number that didn’t budge from 2019 to 2022. (The numbers are worse for pediatric trials, a recent study reported.) The late results included the institute’s own NIH- a. , headed by the National Cancer Institute, where 81 trials were registered late in the period.
Deborah Zarin, who ran ClinicalTrials.gov from 2005 to 2018, argues that registering trials and reporting results is just as important as obtaining informed consent from researchers to participate in a study. “What if I told you that 18% of trials did not obtain informed consent?” You’d probably be appalled,” says Zarin, who is now at Harvard University and Brigham and Women’s Hospital. She and others note that the information is needed for many reasons, from ensuring that two research groups don’t repeat the same trial to uncovering failed trials that often go unpublished so others can steer clear of those approaches.
Till Bruckner, a policy analyst who founded TranspariMED, a campaign aimed at ending the distortion of evidence in medicine, calls the NIH’s recent actions “an improvement.”
But Bruckner thinks the NIH should pull funding from entire institutions with a record of poor compliance. “If the NIH just once did a proper job of cracking down on institutions, not just individuals, it would send such a strong signal that 95% of future problems would be solved.”