STAT+: When FDA rattles its sabre, drug makers and universities start reporting overdue trial results
Over the past eight years, more than 90% of drug makers and universities that received preliminary warnings from U.S. regulators about overdue clinical trial results responded by quickly providing the information to a federal database, a new analysis found.
Using Freedom of Information Act requests, researchers obtained 58 preliminary warnings the FDA sent to clinical trial sponsors — including 32 issued to drug makers — from 2013 through April 2021. Of these, 57 described potential missing trial results and one referred to missing information about registering a clinical trial, according to the analysis, which was published in JAMA.
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