FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov
- For Immediate Release:
- Statement From:
Janet Woodcock, M.D.
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 U.S. Food and Drug Administration works with responsible parties to encourage compliance with the requirements to submit registration and summary results information to the ClinicalTrials.gov data bank, 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 the ClinicalTrials.gov data bank 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.
The FDA has determined that a responsible party who received a Pre-Notice of Noncompliance has not complied with its legal reporting obligations. Accordingly, today, the FDA issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) for failing to submit required summary results information to ClinicalTrials.gov. 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.
The Notice of Noncompliance has also been posted to the FDA’s website and information about the noncompliance will be posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.
The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements. When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jeremy Kahn
- (301) 796-8671