An FDA review of records in the U.S. clinical trials database shows that results have not been reported for 30% of clinical studies, the agency said on Monday. To remedy this shortfall, the U.S. regulator has sent messages to 2,200 drug companies, medical device manufacturers and researchers urging them to report their results.
This is the first step for the FDA in its enforcement of trial reporting, as gaps in the public record obscure the “true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures,” the agency said in a release. The gap also distorts the perception of the effectiveness and safety of medical products, the agency said.
“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community,” FDA Commissioner Marty Makary, M.D., said in a release. “Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers. If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”
Clinical trial sponsors are required to report the results of clinical trials within a year of the study’s completion. The requirement does not include safety, dose-finding or first-in-human phase 1 studies or feasibility studies for medical devices.
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The FDA said it sent the 2,200-plus reminders two weeks ago, with the recipients responsible for some 3,000 clinical trials. Some of these trials were publicly funded, the FDA added. In the messages, the FDA said that it is seeking voluntary compliance with the requirement.
Further enforcement actions the FDA can take include a Preliminary Notice of Non-Compliance warning letter or the most serious notification, which comes in the form of a Notice of Non-Compliance, which can include a penalty of up to $10,000.
Over the last 13 years, the FDA has sent 232 preliminary notices to sponsors. Since 2021, it has sent out just eight non-compliance letters. In 2021, one of those non-compliance notices went to Acceleron, with the FDA giving it 30 days to report results from a trial which began in 2012 for a scrapped cancer drug. In 2022, Ocugen (PDF) was also threatened with a fine for non-compliance.
