Rep. Frank Pallone, Jr. (D-N.J.) is pressing the FDA and NIH on their efforts to ensure ClinicalTrials.gov reporting requirements are followed, referencing recent findings in a letter to the agency chiefs that show significant sponsor compliance issues.

In a Jan. 19 letter to FDA Commissioner Robert Califf and NIH Acting Director Lawrence Tabak, Pallone, ranking member of the House Energy and Commerce Committee, cites a number of studies, including a recent federal analysis of CT.gov results reporting, that reveal a lack of compliance from sponsors.

That study, a 2022 report from the HHS’ Office of Inspector General, looked at publicly funded trials and found that, of 72 NIH-funded trials, 37 (51 percent) did not comply with reporting requirements (CenterWatch Weekly, Aug. 22, 2022). Another study of all registered trials completed after January 2017, conducted in 2021 by the University of Oxford, found that sponsors of only 40 percent of trials with reporting requirements reported on time, while fewer than 69 percent reported at any time, with academic medical centers particularly lacking in timeliness and completeness (CenterWatch Weekly, June 7, 2021).

Additionally, a study conducted by Universities Allied for Essential Medicines in 2021 looked at the top 40 publicly funded U.S. research institutions and, while they saw a decrease in unreported university trial results between 2019 and 2021, also found that 23 of the 40 institutions weren’t fully compliant with CT.gov requirements. In total, more than 100 trials still had results missing from the CT.gov database, the analysis revealed.

“These studies show that sponsors of several thousand trials have been in violation … and yet it appears FDA and NIH have taken only modest compliance actions since reporting requirements first went into effect in 2007,” Pallone said. “While compliance with CT.gov reporting requirements has slowly but steadily improved since 2007, significant gaps remain.”

Pallone’s letter poses a number of questions about FDA and NIH enforcement actions for sponsors that remain noncompliant, with particular concern surrounding the FDA’s “very limited action to ensure compliance” to date. “This is concerning considering that it is apparent when FDA takes action, it has great effect,” the letter reads.

Criticism has been lobbed at the FDA and NIH for failing to put teeth behind their enforcement actions, and the FDA in particular has been called out for declining to fine noncompliant sponsors, though it has the legal power to do so. In May 2021, the agency issued its first noncompliance letter to a sponsor, Acceleron Pharma, garnering praise and offering assurance that clinical trial transparency is a priority (CenterWatch Weekly, May 3, 2021).

Thus far, the FDA has sent out just four letters of noncompliance, none of which were accompanied by civil monetary penalties, according to the agency’s website.

Read Rep. Pallone’s letter here: https://bit.ly/3kvJDhI.