Earlier this year, the Health and Human Services Office of Inspector General (HHS OIG) conducted an audit on the National Institutes of Health (NIH) to determine whether the NIH and other responsible parties complied with federal reporting requirements in clinical trials.
NIH provides funding for clinical trials in several ways: (1) the trials are carried out by NIH scientists in NIH laboratories on its campuses (Intramural clinical trials) or (2) through awards to the scientists at universities, medical centers, hospitals, and research institutions throughout the United States and even internationally (Extramural clinical trials). NIH is then responsible for ensuring that all clinical trials funded by the NIH – both Intramural and Extramural – are reported on ClinicalTrials.gov.
HHS OIG reviewed the 72 NIH-funded Intramural and Extramural clinical trials for which Federal law and NIH policy required that the results be reported in either calendar year 2019 or 2020. HHS OIG compared the date the results should have been submitted with the date they were submitted to determine whether the responsible parties complied with the reporting requirements. HHS OIG also looked to see whether NIH posted the clinical trial results that were submitted by responsible parties to ClinicalTrials.gov within 30 days of the submission date.
Findings
HHS OIG found that NIH did not ensure that all Intramural and Extramural clinical trials complied with the federal reporting requirements. Of the 72 clinical trials that required results to be submitted in either 2019 or 2020, about half were submitted on time (35 – 20 Intramural and 15 Extramural), while 12 were submitted late (11 Intramural and 1 Extramural) and 25 were not submitted at all (5 Intramural and 20 Extramural). There were 16 responsible parties associated with the delayed Intramural clinical trials; of those 16 responsible parties, 15 received a notice of noncompliance from the Office of Protocol Services. When it comes to the delayed Extramural clinical trial reporting, only one of the 21 responsible parties received a notice of noncompliance from the Office of Policy for Extramural Research Administration. That responsible party submitted the results of that clinical trial 299 days late.
For all 47 NIH-funded clinical trials in which the results were submitted (35 on time and 12 late), NIH posted the results to ClinicalTrials.gov, with an average posting timeline of 14 days.
HHS OIG noted that the noncompliance with the federal reporting requirements happened for several reasons, including that NIH lacked adequate procedures for ensuring that the responsible parties actually submitted the results of clinical trials and the agency took limited enforcement action with noncompliance.
Recommendations and NIH Comments
HHS OIG made three recommendations to prevent such noncompliance in the future: (1) NIH should improve its procedures to ensure that responsible parties of all NIH-funded clinical trials comply with requirements to submit results in a timely manner; (2) take enforcement action when the responsible parties fail to submit trial results in a timely manner; and (3) work with responsible parties to learn and understand their own challenges relating to these requirements, and then implement procedures that address those challenges.
NIH concurred with the three recommendations, and even noted it has already started implementing changes to its own internal procedures to better allow the agency to take compliance actions against non-compliant responsible parties.