The following is attributed to Acting Commissioner of the United States Food and Drug Administration (FDA) Janet Woodcock, MD. The full press release of the agency’s very first of its kind is available Here.
The FDA has determined that a responsible party who received advance notice of non-compliance with expectations for submitting clinical trial results to ClinicalTrials.gov has failed to meet its statutory reporting requirements. Accordingly, on April 28, 2021, the FDA issued its first non-compliance notice to Acceleron Pharma, Inc. (Acceleron) for failing to submit the required summary result information to the federal database.
The company’s applicable clinical study evaluated the safety and efficacy of the drug Dalantercept in combination with axitinib in patients with advanced renal cell carcinoma. The notification of non-compliance gives Acceleron 30 days to provide the required summary information about results. The FDA has the right to seek civil fines from Acceleron for violations, including additional civil fines, if Acceleron fails to provide the required information within the 30-day period.
The transparency of the results of completed clinical studies enables important advances in the development of medical devices and helps ensure a safe, effective and efficient clinical research company. For all types of medical device studies, the FDA works with those responsible to promote compliance with the requirements for submitting registration and summary results information to ClinicalTrials.gov, which is maintained by the National Institutes of Health (NIH) / National Library of Medicine .
Clinical trial sponsors can represent a variety of organizations, including academic institutions, hospitals, private companies, and government research organizations, or can be individual researchers. According to federal law, responsible parties, usually trial sponsors, must register subjective clinical trials on ClinicalTrials.gov within 21 days of the first subject’s registration and provide certain summary information about the results of these trials, typically no later than one year after the trial is completed unless an extension of the deadline is received.
The FDA will decide whether those responsible meet the legal requirements for submitting information to ClinicalTrials.gov for applicable clinical trials. These legal and regulatory requirements are intended to create more transparency regarding clinical trials and ultimately enable the broader scientific community to build on the information submitted. Submitting and posting clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and builds public confidence by maintaining a transparent and solid public record of clinical trials and information on their results to be created. If these legal requirements are not met, the FDA has the power to take enforcement action.
The agency has previously set out its approach to determine whether those responsible have not submitted the required registration and / or summary result information to ClinicalTrials.gov for applicable clinical trials investigating drugs, biological products and device products. Although many responsible parties comply with the law without FDA action, the agency has sent Pre-Notices of Noncompliance (more than 40 so far) to encourage voluntary compliance with the ClinicalTrials.gov requirements.
Edited by Gary Cramer