FDA Letter Signals Seriousness of Submitting Results to ClinicalTrials.gov

Miah Jung, PharmD, Pharmacologist, FDA

“We take [compliance with ClinicalTrials.gov] requirements seriously,” says Miah Jung, PharmD, a pharmacologist with the U.S. Food and Drug Administration (FDA).

While the FDA “hopes for voluntary compliance,” the agency also wants regulated entities to understand the importance of compliance and the potential consequences of failing to meet regulatory expectations, adds Jan Hewett, BSN, JD, regulatory counsel (policy) with the FDA Center for Drug Evaluation and Research.

Jung and Hewett will lead a session during the next round of the ACRP 2021 virtual conference in September that is designed to help regulated entities have a clear handle on definitions, requirements, and the FDA’s general expectations when it comes to the importance of submitting information to the ClinicalTrials.gov database.

Recently, the FDA took public action that demonstrated its commitment to enforcing the regulations. “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,” said acting FDA Commissioner Janet Woodcock while announcing the agency’s first Pre-Notice of Noncompliance action against Acceleron in late April for alleged noncompliance with ClinicalTrials.gov compliance requirements.

“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, Woodcock added.

FDA’s Oversight of ClinicalTrials.gov Requirements

Join Jung and colleague Jan Hewett this September as ACRP 2021 resumes with a deep dive of Regulatory Trends & Compliance. Jung and Hewett will provide an overview of the definitions and requirements for registration and submission of results requirements to ClinicalTrials.gov. This session will also describe FDA’s role in the compliance and enforcement of ClinicalTrials.gov, as well as a review of available FDA resources for those involved in ClinicalTrials.gov clinical trials.

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“We hope our session can help to clear up misunderstandings” and make it easier for clinical trial practitioners to understand both FDA and NIH’s unique roles in managing ClinicalTrials.gov, Hewett said.

“Some may understand better than others” in terms of the FDA’s expectations, Jung said. “It is important to [share] results to ClinicalTrials.gov,” she added, noting that doing so helps “advance safer clinical research.”

Author: Michael Causey