The world’s largest medical research funder has blocked two researchers from launching new projects after they violated NIH policies on clinical trial reporting.
According to a recent audit report:
“Results had not been reported within 1 year of the primary completion date, as required by the NIH 2016 dissemination policy. NIH officials told us the principal investigators of these two trials reported trials results on ClinicalTrials.gov after NIH had withheld approval of new research.”
Both individuals were working as intramural researchers within an NIH-affiliated institute.
Annual NIH trials budget: $5 billion
Every year, the NIH spends more than $5 billion of taxpayers’ money on clinical trials. In the past, much of that money was wasted because trial results were not made public.
Most of the NIH trials budget – approximately $4 billion – is disbursed to universities and for-profit companies in the form of research grants. The remaining $1 billion is spent on intramural research.
According to the report:
“NIH funded over 9,000 grants supporting clinical trials that tested drugs and other interventions in fiscal year 2021… For fiscal years 2017 through 2021, NIH reported that it obligated… $28 billion for clinical trials… We found that the number of NIH-funded clinical trials registered on ClinicalTrials.gov in each fiscal year from 2019 through 2022 ranged from 1,385 to 1,485.”
One person monitors $4 billion in grants
A single compliance officer is tasked with monitoring whether the recipients of $4 billion in extramural grants actually register trials and make their results public on ClinicalTrials.gov, the audit reveals.
This weak oversight has resulted in weak compliance with NIH rules designed to curb research waste. Over a four year period, the National Cancer Institute alone failed to properly register 81 trials. Despite these repeated violations of NIH policies, the agency never froze funding to the institute.
New policies and systems boost compliance
Improved NIH oversight and more active engagement has already brought hundreds of delinquent grantees into compliance, the agency notes.
In the wake of sustained pressure from Congress and advocacy groups, NIH is now prompting staff and grantees whose trial results are overdue. The agency has also strengthened its policies and monitoring systems.
NIH's efforts appear to have significantly boosted trial registration and results reporting.
However, NIH has still not cut off funding to any noncompliant grantees – thus failing to deliver on a promise made by Joe Biden in 2016. It also appears that NIH has not hired additional compliance staff.
Key findings at a glance
Highlights of the audit report:
One in six NIH trials were not prospectively registered
Half of trial results were made public late or not at all
NIH has started actively monitoring extramural grants
But: only one grants compliance officer monitors registration and reporting
NIH staff who break the rules now risk losing their jobs
Compliance has significantly improved thank to these measures
But: NIH has not yet suspended any funding
Key passages of the report are reproduced verbatim below.
One in six trials were not preregistered
We also found that some of the NIH-funded trials that were registered late involved testing drugs… 9 to 10 percent of such trials… were registered late.
We found that, among NIH institutes and centers, the National Cancer Institute and the National Heart, Lung, and Blood Institute sponsored the largest number of drug trials that were registered late: 81 and 18, respectively, in fiscal years 2019 through 2022. Among nonfederal entities, two medical centers with the largest number of late-registered NIH-funded clinical trials sponsored 34 of them during those 4 years.
Our analysis shows that similar percentages of NIH-funded clinical trials were registered late in fiscal year 2022 compared to the previous 3 fiscal years. This could be because not enough time has passed for the agency’s corrective actions to take effect for all NIH-funded clinical trials.
Timely registration of NIH-funded clinical trials and reporting of their results on ClinicalTrials.gov is important for improving transparency of NIH research to advance clinical interventions and drug development.
Half of trial results not reported
Only about half of NIH-funded clinical trials submitted results on time to the database in calendar years 2019 and 2020 due to insufficient monitoring and enforcement by NIH.
Invisible research results benefit neither science nor patients, and are therefore a waste of public money.
TranspariMED note: The GAO team did not conduct an independent audit of trial reporting. Instead, their report cites previously published OIG audit figures. A separate, larger academic study recently found that 48% of pediatric trials funded by NIH had not published results.
NIH now actively monitors grants
For extramural clinical trials, NIH introduced two measures to improve compliance.
First, NIH modified its grant review process to incorporate automatic checks and notifications, according to NIH officials. NIH generally verifies grantees’ compliance with the requirements for ClinicalTrials.gov once a year when NIH program officers review grantees’ annual progress reports. Beginning in October 2021, an automatic check prevents grant recipients from submitting annual progress reports without proof that they registered and reported the results of clinical trials funded by their grants on ClinicalTrials.gov as required.
NIH also began to generate quarterly reports, which include data imported from ClinicalTrials.gov, to determine the number of potentially noncompliant extramural trials and monitor rates of noncompliance.
New NIH compliance procedure
Second, in July 2022, NIH created a new compliance procedure for extramural clinical trials subject to the NIH 2016 dissemination policy. The procedure requires two levels of outreach: first, through the funding institute or center and, second, from the Office of Policy for Extramural Research Administration, to bring the recipient into compliance before NIH takes an enforcement action.
According to NIH officials, a grants compliance officer at the Office of Policy for Extramural Research Administration monitors grantees’ compliance with the requirements for ClinicalTrials.gov. [According to NIH officials, this position has existed for over a decade, and is one of 12 compliance officer positions for the extramural program.]
Over 200 grantees brought into compliance
If the recipients do not address NIH’s concerns within 60 days of the initial NIH notification, NIH can suspend grant funding.
NIH officials told us that, under the new procedure, NIH had brought 235 delinquent grantees into compliance as of November 2022.
Further, officials said they expected improved grantee compliance as a result of notification and outreach actions, without having to enforce compliance by suspending funding. [NIH officials told us that the agency has never suspended grant funding for noncompliance with the requirements for ClinicalTrials.gov.]
Report results or lose your job
For intramural clinical trials, NIH began requiring in January 2022 both principal investigators and NIH leadership to be notified of failure to comply with registration and result reporting requirements. It also modified procedures during the HHS audit for taking corrective actions regarding intramural researchers who failed to comply with ClinicalTrials.gov reporting requirements.
Effective January 14, 2022, NIH can issue letters of reprimand or remove intramural researchers from federal service if they fail to comply with the NIH and federal requirements for ClinicalTrials.gov, among other things. [For the current procedures, see the NIH Policy Manual.]
Before these changes, NIH only notified, but did not penalize, intramural researchers who did not comply with the requirements.
New NIH policies have boosted compliance
According to NIH officials, as a result of these actions, all 775 active intramural clinical trials were registered on ClinicalTrials.gov as of November 2022.
In addition, principal investigators of all 49 intramural trials subject to the result reporting requirement in 2022 reported their results as of December 2022.
These 49 trials included two for which results had not been reported within 1 year of the primary completion date, as required by the NIH 2016 dissemination policy. NIH officials told us the principal investigators of these two trials reported trials results on ClinicalTrials.gov after NIH had withheld approval of new research and initiated other actions consistent with the procedures that took effect in January 2022.
NIH outlines options for sanctions
The specific enforcement actions for noncompliance with NIH and federal requirements for ClinicalTrials.gov depend on whether an NIH-funded trial meets the definition of the “applicable clinical trial” under the Food and Drug Administration Amendments Act of 2007, as implemented through federal regulation in 42 C.F.R. § 11.22.
If the noncompliant trial meets the definition of the applicable clinical trial under the act, NIH can suspend funding to the grant recipient on an institution-wide basis. NIH notifies FDA when an enforcement action is taken against recipients whose NIH-funded applicable clinical trials have failed to comply with requirements.
If the noncompliant trial does not meet that definition and is covered only by the NIH 2016 dissemination policy, NIH can suspend funding of the specific award supporting the noncompliant trial.
The audit report was produced by the Government Accountability Office following a request by two members of Congress, Representative Jamie Raskin and Senator Debbie Stabenow. The audit was conducted from January 2022 to April 2023.
A few months from now, the FDA will be presenting its own plans to crack down on unregistered and unreported trials, in response to a Citizen Petition filed by Universities Allied for Essential Medicines and supported by TranspariMED.
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