The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) says the National Institutes of Health (NIH) has failed to hold NIH-funded researchers accountable for publishing clinical trial data. The watchdog agency has made several recommendations to ensure better transparency in the future. The OIG published a report on August 12 criticizing the NIH for not fully enforcing federal reporting requirements for intramural and extramural studies that it funds.
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Federal law requires clinical trial sponsors to submit results for their studies registered on ClinicalTrials.gov, generally no later than one year after the study’s completion date. However, according to an OIG audit of all 72 NIH-funded clinical trials for which responsible parties were required to submit results in 2019 or 2020, most studies did not have their results timely submitted.
OIG concluded that “noncompliance with federal reporting requirements occurred because NIH did not have adequate procedures for ensuring that responsible parties submitted the results of clinical trials, took limited enforcement action when there was noncompliance, and continued to fund new research of responsible parties that had not submitted the results of their completed clinical trials.”
OIG’s recommendations included that NIH improve its procedures to ensure that responsible parties of NIH-funded clinical trials comply with requirements to submit results to ClinicalTrials.gov on time. Furthermore, OIG said the NIH should take enforcement action against responsible parties that are late in submitting trial results or do not submit results. Finally, OIG asked NIH to work with the responsible parties to understand their challenges related to ClinicalTrials.gov and implement procedures to address the challenges.
NIH agreed with OIG’s recommendations, and described activities it would undertake to “enhance NIH’s ability to take compliance actions against responsible parties that are late in submitting trial results, or do not submit results.” Many of the activities described by NIH appear to be specific to NIH-funded studies, such as not issuing subsequent awards for NIH extramural grants until compliance with ClinicalTrials.gov requirements is assessed. Therefore, the immediate impact of OIG’s audit may be limited to NIH-funded studies.
This OIG report comes after FDA issued its first Notice of Noncompliance last year to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. Since then, FDA has only posted three additional Notices of Noncompliance, so enforcement actions by FDA for noncompliance with ClinicalTrials.gov requirements have remained relatively infrequent thus far.