FDA Urges ClinicalTrials.gov Compliance
FDA says it is continuing to advance its compliance activities associated with required clinical trial information postings in the ClinicalTrials.gov database. “Transparency of clinical trial information, including through ClinicalTrials.gov, is essential to scientific advancement,” FDA commissioner Robert Califf says in an online post about reporting trial results. “Making clinical trial information publicly available fulfills the commitment to volunteer research participants and also enhances public trust. Simply put: if a human experimental study is done and the existence of the study and the results are not publicly available, it is difficult to assert that obligation of the researchers to contribute to generalizable knowledge has been met.”
Califf’s post points out that one of the important benefits of reporting trial results is the knowledge gained from “the sharing of results that are unfavorable to the study sponsor or the investigators.” Before the database went online, many of these negative studies went unreported in the scientific literature, leading to a biased perspective on the benefits and risks of interventions.
Currently, the ClinicalTrials.gov database provides information on almost half a million clinical trials. According to Califf, less than 15% of the entries appear to be applicable clinical trials (ACTs) subject to FDA oversight of registration and results information submission requirements. “Although the FDA is not tasked with enforcing the submission of results information for the more than 85% of registered trials that are not ACTs, there is an ethical obligation on the part of sponsors, trialists, and their associated institutions, to make results of trials available to the public, and this obligation can be met by submitting results information to the ClinicalTrials.gov database,” he says.
As part of its compliance efforts, Califf says FDA issues a Preliminary Notice of Noncompliance (Pre-Notice) to encourage voluntary compliance when it learns about a missed information posting. “Failure to address potential violations after receiving a Pre-Notice may result in further FDA regulatory action, including a Notice of Noncompliance and/or civil money penalties,” he says. “Our Pre-Notices and Notices of Noncompliance are highly effective. For example, to date, more than 90% of the over 100 Pre-Notices issued resulted in responsible parties successfully addressing any potential noncompliance. None of the Notices of Noncompliance required further FDA regulatory action.”