FDA Criticizes Clinical Trial Sponsors for Lack of Transparency, Threatens Non-Compliance Notices
The FDA has initiated a campaign to ensure clinical trial sponsors disclose the results of their studies, highlighting that approximately one-third of trials remain unreported. The agency has sent reminders to around 2,200 product manufacturers and researchers about their obligation to report study results to the clinicaltrials.gov database. According to the FDA, 29.6% of clinical trials that are likely subject to mandatory reporting have not uploaded their results. This lack of transparency has been a contentious issue in the pharmaceutical industry, with the FDA previously issuing warning notices to companies and researchers who failed to comply with federal law. Current U.S. regulations require that results from phase 2 to 4 trials of FDA-regulated drugs, biologics, and devices be reported within 12 months of the study's primary completion date. The FDA has warned that failure to meet these standards could result in notices of non-compliance, potentially leading to fines. 
