Researchers Call for Better Access to FDA Reports on Clinical Trial Misconduct
Clinical trial investigators from the U.S. and Europe are calling for the FDA to consider proactively disclosing clinical trial inspection reports and results of clinical trial irregularities and misconduct to the public.
While disclosing trial misconduct may improve current standards for clinical trial transparency, inspection reports are generally not proactively made available because they may contain confidential commercial information about an investigational product.
In an April 23 viewpoint article in JAMA, researchers recommend that the FDA should consider mandating the posting of inspection reports and findings of clinical trial irregularities and misconduct on the agency’s website and ClinicalTrials.gov. Publicly available inspection reports, the authors suggest, could be taken into consideration in meta-analyses, consensus statements and clinical practice guidelines, which may ultimately impact patient care.
The researchers who wrote the JAMA article — Dr. Rafael Dal-Ré, from the Autonomous University of Madrid in Spain, Dr. Aaron Kesselheim, from Brigham and Women’s Hospital and Harvard Medical School in Boston, and Dr. Florence T. Bourgeois, from Boston Children’s Hospital and Harvard Medical School — argue that disclosing this information may ultimately improve conduct standards for clinical trials.