The following is attributed to Acting U.S. Food and Drug Administration (FDA) Commissioner Janet Woodcock, MD. The full press release about the first-ever action by the agency of this sort is available here.
The FDA has determined that a responsible party who received a Pre-Notice of Noncompliance with the expectations for submission of results from a clinical trial to ClinicalTrials.gov has not complied with its legal reporting obligations. Accordingly, on April 28, 2021 the FDA issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) for failing to submit required summary results information to the federal database.
The company’s applicable clinical trial evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period.
Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective, and efficient clinical research enterprise. Across all types of medical product trials, the FDA works with responsible parties to encourage compliance with the requirements to submit registration and summary results information to ClinicalTrials.gov, which is managed by the National Institutes of Health (NIH)/National Library of Medicine.
Sponsors of clinical trials may represent a variety of organizations, including academic institutions, hospitals, private companies, and government research organizations, or could be individual researchers. Federal law requires that responsible parties, typically trial sponsors, register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.
The FDA makes determinations about whether responsible parties are complying with legal requirements for submitting information to ClinicalTrials.gov for applicable clinical trials. These statutory and regulatory requirements are intended to provide greater transparency regarding clinical trials, ultimately allowing the broader scientific community to build on the information submitted. The submission to and posting of clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public trust by creating a transparent and robust public record of clinical trials and information about their results. When these legal requirements are not met, the FDA has the authority to take enforcement action.
The agency has previously outlined its approach to identifying whether responsible parties have failed to submit required registration and/or summary results information to ClinicalTrials.gov for applicable clinical trials studying drug products, 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 to date) to encourage voluntary compliance with the ClinicalTrials.gov requirements.
Edited by Gary Cramer