NIH Clinical Trials Reporting Compliance: A Shared Commitment


As the largest public funder of clinical trials in the United States, NIH is committed to the timely dissemination of clinical trial results information so that the benefits of the trial data can be realized. In support of this goal, in September 2016, NIH issued the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information to establish our expectation that summary results of NIH-supported clinical trials be submitted to within 365 days of the actual primary completion date. This policy is complementary to a 2016 updated HHS regulation aimed at further increasing the availability of information about clinical trials.

This policy has already proven to be effective as recent analyses have demonstrated increased clinical trial results information reporting. However, we acknowledge that we still have work to do to increase timely compliance. As such, NIH has implemented multiple strategies, including targeted compliance actions, to get us to our goal. As partners in the clinical trial enterprise, we can fulfill our shared commitment to ensuring clinical trials results information is available to benefit all human health.

Most recently, a report from the DHHS Office of the Inspector General (OIG) reviewed NIH-funded clinical trials for which the HHS regulation and NIH policy required the results to be reported in calendar year 2019 or 2020. The OIG found that compliance with Federal reporting requirements could be enhanced by strengthened procedures for ensuring that responsible parties submitted the results of clinical trials. NIH agreed with this finding as it was one of the impetuses for championing the 2016 policy and updated HHS regulation.

Alongside strengthening our policies, NIH has committed to updating our internal controls over the course of the last 5 years NIH to improve our ability to track and enforce clinical trial results information submission, including:

  • Developing a compliance review process and associated systems controls that provide a robust and automated system for centralized tracking of registration and results reporting information.
  • Substantially investing in the human subjects eRA module that collects structured data from application forms and links those data to, enabling NIH staff to rapidly identify potentially noncompliant trials and to take actions to ensure compliance.
  • Initiating internal quarterly reporting to NIH Institutes and Centers (ICs) of all NIH grant-funded clinical trials that have not submitted results information to within the deadline, enabling NIH to send an initial notification to recipients of potential noncompliance.

To assess our progress with results information submission to beyond 2020, we conducted analyses of NIH-grant-funded clinical trials for which main results were due in FY 2020, FY 2021 or FY 2022. Time to report was the number of days elapsed between the actual primary completion date and the date of initial submission of main results (primary outcome); in cases of no results information submission at all, the time to report was the number of days elapsed between the primary completion date and March 8, 2023. Trials were compliant if the date for submitting results information was within 365 days of the actual primary completion date.

After our systems had been implemented, a total of 530 trials had results information due in FY 2020, FY 2021 or FY 2022. Our analyses show that of these trials, 96% had results information submitted to (see Table 1). This is in stark comparison to compliance rates before our policies were enacted. But we note that still only a minority of trials (37%) submitted results information on time.

Table 1: Compliance status of NIH-grant-funded clinical trials according to fiscal year when main results were due. Trials were compliant if they submitted main results reports within 365 days of the actual primary completion rate. Except for the top row, percentages are according to column numbers.

Characteristic FY 2020 FY 2021 FY 2022
Total N (%) 56 (10.6) 163 (30.8) 311 (58.7)
Compliance Status Compliant 16 (28.6) 56 (34.4) 126 (40.5)
Late Report 37 (66.1) 103 (63.2) 171 (55.0)
No Report 3 (5.4) 4 (2.5) 14 (4.5)
Time to Report (Days) Median (IQR) 740.0 (363.0 to 1147.2) 454.0 (356.0 to 754.0) 400.0 (349.0 to 477.5)

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. But we also are looking to you to help. 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 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.

How you can help with NIH clinical trials reporting compliance • Investigators, submit your results to ASAP • Institutional leaders, develop internal controls to make it easier for faculty to report results efficiently • If you receive a letter about a non-compliant trial, be responsive


Correction: This blog has been updated to clarify that results information are expected to be submitted within 365 days of the actual primary completion date. Analyses in Table 1 are for results submitted to


  1. Good morning. Are you familiar with the Physicians Committee for Responsible Medicine? They promote non-animal experiments by using modern technology which is a rapidly growing field. It reduces the need to experiment on live animals and saves precious funds. They are ready to work with you. Please consider it. This is after all, the digital age and experimenting on sentient animals is so Middle Ages.

  2. You might improve compliance if the portal interface was less….challenging to use. I recommend you have a workshop with a handful of investigators, and work with them to complete a trial report. You’ll see that the portal is not intuitive nor user friendly.

    1. Agreed. Even with the friendly support from Clinical Trials. gov, we had ongoing difficulty using its portal.

  3. This effort by NIH is excellent, and clearly shows that active NIH engagement can substantially curb research waste in clinical trials.
    The next logical step for NIH should be to audit its past clinical trials portfolio, identify all trials that have remained unreported, and remind those responsible to make the results public. For example, the public funder of New Zealand recently audited its entire trial portfolio going back to 1999 (“New Zealand: Clinical trials audit finds high reporting rates but slow reporting speeds”). Even for trials completed when there was no legal obligation to report results, simple reminders could have a strong impact:
    Experience from Europe’s EudraCT registry shows that sponsors can typically recover the results of trials >10 years old and upload them onto registries.
    It’s fantastic that NIH is tackling this issue going forward, but NIH cannot and should not walk away from its legacy research waste. Identifying and sending out reminders for legacy unreported trials would be a highly cost-effective way of increasing the global store of medical knowledge – and certainly far cheaper than funding the same trials a second time to fill the knowledge gaps left by past non-reporting.

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