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 ClinicalTrials.gov 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 ClinicalTrials.gov, 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 ClinicalTrials.gov within the deadline, enabling NIH to send an initial notification to recipients of potential noncompliance.
To assess our progress with results information submission to ClinicalTrials.gov 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 ClinicalTrials.gov (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 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.
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 ClinicalTrials.gov.