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November 12, 2021

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

Author Affiliations
  • 1National Clinician Scholars Program, Yale School of Medicine, Department of Internal Medicine, New Haven, Connecticut
  • 2Veterans Affairs Connecticut Healthcare System and Yale University, West Haven, Connecticut
  • 3Columbia Law School, New York, New York
  • 4Global Health Justice Partnership, Yale Law School, New Haven, Connecticut
  • 5Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut
JAMA. 2021;326(21):2131-2132. doi:10.1001/jama.2021.19773

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?

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1 Comment for this article
Quick But Incomplete Fixes
Bob Roehr, MS | Freelance biomedical Journalist; Past member two NIH advisory committees
Growing up my father taught me the job isn't done until the paperwork is completed. That should certainly apply to clinical trials where volunteer patients take on the risks of participating. 

For academic studies, the NIH should certify that reporting requirements are current, and if such reporting is not current, the the NIH should not release any new funds. Researchers and institutions habitually delinquent in reporting should not be allowed to file new grant applications.

There is no such financial stick to use with industry. However if a drug is approved and the required information has not
been published in a journal then the FDA should make public the voluminous information the sponsor has filed for that approval. Most companies would prefer that the public record consist of papers it has vetted and spun rather than the far larger mass of raw data.

Such changes would greatly enhance compliance.