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NIH-Funded Pediatric Clinical Trial Data Not Readily Available, Study Shows

A study in JAMA Network Open by researchers from Boston Children's Hospital and elsewhere finds that data for most National Institutes of Health-funded pediatric clinical trials are not readily available for reuse. Starting January 25, 2023, the NIH requires researchers to describe their plans and methods to share participant data. This cross-sectional study analyzed NIH-funded pediatric clinical trials with grants completed between 2017 and 2019 and trial results published in peer-reviewed publications by June 30, 2022. Among 213 pediatric clinical trial publications analyzed, only 32.4 percent or 69 studies, included a data-sharing statement, and 29.1 percent or 62 declared that data were available. The researchers note that publications in the International Committee of Medical Journal Editors (ICMJE)-affiliated journals were not more likely to provide data-sharing reports than those in non-ICMJE-affiliated journals. "These findings are consistent with prior studies indicating that access to individual trial participant data remains limited, even among trials published in ICMJE-affiliated journals," the authors write. They note, though, that their findings can't be generalized to trials studying adults or to those funded by non-NIH entities.