FDA, NIH Must Penalize Researchers Who Don’t Report Trial Results, House Member Says

Researchers may be legally required to report clinical trial results to the federal government, but many of them aren’t doing it, and they’re not being penalized for it — something which needs to be remedied, according to one high-ranking House member.

“According to a recent study, sponsors of 31% of registered trials required to report results have failed to report any results, and another 30% of sponsors of registered trials required to report results failed to do so on time, totaling 5,364 trials in violation of applicable reporting requirements,” Rep. Frank Pallone (D-N.J.), ranking member of the House Energy & Commerce Committee, wrote Thursday in a letter to NIH Acting Director Lawrence Tabak, DDS, PhD, and FDA Commissioner Robert Califf, MD.

Pallone also cited a 2022 study from the HHS Office of Inspector General, which found that of 72 reviewed clinical trials funded by the NIH, 37 failed to comply with applicable reporting requirements and either submitted results late or not at all. “Despite these troubling results, the FDA and NIH have only carried out limited enforcement activities for failure to comply with ClinicalTrials.gov requirements,” Pallone noted, referring to the government-funded publicly available database of clinical trials and their results.

Pallone explained that “Congress originally required NIH to establish a public database of clinical trials in 1997 to help patients find trials for serious illnesses. In 2007, the FDA Amendments Act expanded the types of trials required to register as well as the types of information required to be submitted, including clinical trial results.”