Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements

On April 28, 2021, the US Food and Drug Administration (FDA) announced that it “issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) for failing to submit required summary results information to ClinicalTrials.gov.”¹ These results were based on a phase 2 trial that reached its primary completion date in June 2017. The trial examined the safety and efficacy of the candidate drug dalantercept in combination with an FDA-approved drug, axitinib, in patients with advanced renal cell carcinoma. Acceleron not only missed its 2018 deadline for submitting results to ClinicalTrials.gov, but also ignored an initial warning (Pre-Notice of Noncompliance) that the FDA sent the company in July 2020.¹ The FDA’s first Notice of Noncompliance was recognized as an important, if long overdue, step by the agency toward fulfilling its responsibility to enforce the federal law that requires clinical trial sponsors to disclose trial results to the public via ClinicalTrials.gov. But, the Notice of Noncompliance also prompts a key question: what comes next for noncompliant trial sponsors and the FDA?