番茄社区

WASHINGTON -- 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 , 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, to NIH Acting Director Lawrence Tabak, DDS, PhD, and FDA Commissioner Robert Califf, MD.

Pallone also cited a 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 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."

"While compliance with ClinicalTrials.gov reporting requirements has slowly but steadily improved since 2007, significant gaps remain," he continued, noting that in the first study he referenced, "sponsors of only 40% of trials required to report results did so within 1 year of completion, as required by law, and under 69% did so at any time. The study also found academic medical centers lagged behind other sponsors in the timeliness and completeness of trial reporting."

Pallone expressed particular disappointment that the FDA, who is responsible for compliance with reporting rules in most cases, has taken so little enforcement action, "considering that it is apparent when FDA takes action, it has great effect." For example, all of the 15 preliminary noncompliance letters the agency sent during a pilot-testing program between 2013 and 2016 resulted in compliance. "Over the next 5 years, FDA issued more than 40 additional [letters], and over 90% of recipients reported missing information shortly after receiving these letters," he added.

However, Pallone wrote, "these actions have only been taken with regard to a tiny fraction of the trials that have been or remain in violation of ClinicalTrials.gov requirements. Additionally, it appears FDA has not sent any compliance letters to NIH, despite the many trials NIH runs or oversees, and for which responsible parties have failed to comply with [reporting] requirements."

NIH, which can affect compliance on studies that it funds, also came in for its share of criticism. "With respect to NIH enforcement for publicly funded studies, [the 2022 OIG report] found that NIH notices of noncompliance 'were not always effective at gaining compliance,'" Pallone noted. "However, OIG concluded NIH 'did not take any additional enforcement actions against responsible parties that failed to submit clinical trial results' beyond notifications of noncompliance, and 'continued to fund new clinical trials' of noncompliant sponsors."

Pallone gave the FDA and NIH until February 17 to respond to the letter, which asks for details from both agencies on noncompliance letters sent and other enforcement actions taken. The Biotechnology Innovation Organization, which represents biotechnology companies, and Universities Allied for Essential Medicines, a group of more than 100 research universities, did not respond to 番茄社区's requests for comment on the letter.

Asked for his organization's comment, Andrew Powaleny, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), said in an email that "PhRMA members are committed to enhancing public health and advancing the development of medicines by sponsoring and conducting clinical research that fully complies with all legal and regulatory requirements. Further, our Principles for Responsible Clinical Trial Data Sharing set forth PhRMA members' commitment to enhancing public health through responsible sharing of clinical trial data in a manner that safeguards the privacy of patients, respects the integrity of national regulatory systems, and maintains incentives for investment in biomedical research."

Comment