The FDA said it reminded more than 2,000 drug companies and researchers about Legal Requirements for Publishing Clinical Trial DataWarning that publication preference for positive trials could skew the available evidence on treatments.
“Too often, companies are suppressing adverse clinical trial results and keeping them secret from patients and the scientific community,” FDA Commissioner Marty Macri, MD, MPH, said in a statement. “Those sponsoring clinical trials have an ethical obligation to make the results public regardless of the impact of the data on the company’s share price.”
Federal requirements created under the FDA Amendments Act of 2007 require reporting to ClinicalTrials.gov within a year for many interventional studies, but an internal FDA analysis found that 29.6% of studies were highly likely to require reporting, but posted no results.
“If you’re a doctor deciding whether to prescribe a drug to a patient, you need to have the best data you can about the clinical studies on that drug,” Macri said.
According to the agency, publication bias toward positive results “obscures the true landscape of drug development outcomes”. “This difference may also lead to a distorted perception of the safety and efficacy of medical products.”
It’s not just pharmaceutical companies that fail to report, top US universities also often fail to report, according to a Analysis From affiliated universities for essential medicines.
In total, the FDA said on Monday, more than 2,200 companies and researchers (generated from more than 3,000 clinical trials) had data flaws and were sent letters on March 30. The messages demand voluntary compliance with test reporting requirements, but the agency can also impose fines.
An op-ed published by Medpage Today Called for more aggressive enforcement of the data reporting law in 2023, saying the agency could issue $45 billion in fines for reporting lapses. “Despite thousands of trials found to violate the law, the FDA has yet to levy any penalties,” the authors wrote at the time.
The FDA said the messages it sent “represent an additional step the agency is taking to provide relevant responsible parties an opportunity to comply with federal law before the agency considers taking further regulatory action.”
