FDA pushes sponsors to publish clinical trial results to close data gaps

The FDA found that results from about 30% of U.S. clinical trials have not been reported in the registry and has sent reminders to over 2,200 sponsors—covering roughly 3,000 trials—to encourage voluntary reporting within a year of completion (with certain safety, dose-finding, and first-in-human device studies excluded). The agency says publishing results combats bias in the public record and can affect perceptions of drug safety and effectiveness; enforcement tools can include non-compliance notices and penalties up to $10,000, though such actions have been uncommon in recent years.