Federal law requires responsible parties (typically 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 summarized its findings as follows:

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;

• take enforcement action against responsible parties that are late in submitting trial results or do not submit results; and

• 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. It is unclear whether OIG’s audit will lead to any broader scrutiny by NIH or the U.S. Food and Drug Administration (FDA) of compliance with ClinicalTrials.gov reporting requirements for studies not funded by NIH.

Next steps

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; we summarized that warning online here. 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. We at Hogan Lovells will continue to monitor whether OIG’s findings of noncompliance for NIH’s studies may prompt FDA to take more frequent enforcement actions against responsible parties that do not meet their ClinicalTrials.gov reporting requirements.

If you have any questions about the impact of OIG’s audit or on clinical trial reporting obligations generally, please contact the Hogan Lovells lawyer with whom you commonly work.

Authored by Bert Lao