A Science investigation reported this week that many companies and medical research institutions fail to meet a long-standing legal mandate to disclose clinical trial results in a federal database. For certain trials, however, compliance is impossible to verify.
In 2016, the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) announced a “final rule” to clarify ClinicalTrials.gov enforcement. At the same time, NIH issued a separate policy, extending reporting requirements for its grantees and intramural scientists to a broader range of studies, including phase I safety trials, small feasibility studies, and behavioral research. On paper, the policy’s wider net suggests NIH planned aggressive enforcement. Some scientists even labeled it overkill—encompassing studies they didn’t consider clinical trials.
In practice, just as NIH has failed to enforce the law for conventional clinical trials, the agency has postponed enforcement for the supplemental policy covering the broader set of experiments. It also has effectively hidden all compliance activity—if any occurs—from public view.
The final rule adopted by FDA and NIH applies to trials whose results became due on ClinicalTrials.gov on or after 18 January 2018. In contrast, the broader NIH policy only applies to those trials funded by grant proposals received 1 year earlier—on or after 18 January 2017—or started by NIH employees on or after that date. With the long lag times between proposal, funding approval, trial completion, and the 1-year grace period for posting results, few trials under this supplemental policy would be likely to face enforceable deadlines for several years.
Moreover, the dates that grant proposals arrive at NIH appear nowhere in ClinicalTrials.gov or any other public source. So no one outside the agency can determine which of that broader set of grantee trials are subject to required reporting of their results.
That opacity raises questions about the agency’s commitment to the principles of openness that led to ClinicalTrials.gov, says physician Ben Goldacre of the University of Oxford, who oversees TrialsTracker, a system that monitors compliance with ClinicalTrials.gov requirements. “If you have … rules operating on secret data, and you never act in public, how is that different from doing nothing?” he asks, calling the NIH approach “regulatory theater.”
Lyric Jorgenson, NIH deputy director for science policy, concedes that failing to make public which recently registered trials are covered by the supplemental policy raises “a valid question.” Nonetheless, confidential efforts to help researchers comply with reporting requirements—rather than outright enforcement, such as withdrawing grant funding—“is always our first step,” she says.
This story was supported by the Science Fund for Investigative Reporting.