OIG Audit: NIH Dropped the Ball on Enforcing Trial Reporting Requirements
It’s not just academia- and industry-funded trials that are lacking in transparency; a recent audit by the Office of Inspector General (OIG) has found that the National Institutes of Health (NIH) failed to ensure that the results of the trials it funded were posted on ClinicalTrials.gov in line with federal reporting requirements.
The audit, which reviewed 72 trials conducted or funded by NIH that are required by federal law and institute policy to post results, found that 25 of them did not comply with these requirements. In total, half (37) of these trials were noncompliant in some fashion.
In comparison, Oxford University’s FDAAA tracker shows that, as of Aug. 17, approximately 3,500 (24 percent) of all clinical trials (federal, industry and private research) listed in CT.gov haven’t posted their findings.
Among NIH trials, those conducted by researchers outside the institutes were found to be the least compliant, with one trial filing results late, 20 failing to submit results entirely and 15 posting results on time. Of trials conducted by NIH researchers, 11 submitted results late, five did not submit findings and 20 filed results on time.
OIG concluded NIH does not have adequate procedures for ensuring that responsible parties submit the results of clinical trials and that it “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.”
In response to the OIG report, NIH agreed that it should improve its procedures, take enforcement action against responsible parties that submit results late or not at all, work with them to understand and identify the reporting hurdles they face, and develop procedures to address those challenges. It has already begun improving its internal procedures and activities to take action against negligent parties, NIH said.
Read the OIG report here: https://bit.ly/3dEppij.
View the FDAAA Tracker website here: https://bit.ly/2HEaAaQ.