• Y Tony Yang and Emily A Largent.
• George Washington University, 1919 Pennsylvania Ave NW, Ste 500, Washington, DC 20006. Email: ytyang@gwu.edu.
• Am J Manag Care. 2021 Feb 1; 27 (2): e34-e35.

AbstractA 2020 federal court ruling requires clinical trial sponsors to report a decade's worth of previously exempted data to the National Institutes of Health (NIH) for publication on ClinicalTrials.gov. In Seife v HHS, the US District Court for the Southern District of New York invalidated NIH regulations that exempted certain clinical trials conducted between 2007 and 2017 from results reporting requirements mandated by the Food and Drug Administration Amendments Act. Sharing data from publicly funded research can maximize the benefits of that research by allowing taxpayers, who effectively fund the research, to see the results of their investment. Regardless of the source of their funding, clinical trial data also facilitate replicability, critical analysis, and trust in the scientific community. These benefits make the recent decision in Seife particularly significant. However, its impact will be dampened if the government does not take steps to enforce it.

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