“We take [compliance with ClinicalTrials.gov] Requirements seriously, ”says Miah Jung, PharmD, pharmacologist with the US Food and Drug Administration (FDA).
While the FDA “hopes for voluntary compliance,” the agency also wants regulated companies to understand the importance of compliance and the potential consequences of not meeting regulatory expectations, adds Jan Hewett, BSN, JD, Regulatory Coun (Policy) at the FDA Center for drug evaluation and research.
Jung and Hewett will host a session during the next round of the ACRP 2021 virtual conference in September to help supervised companies understand definitions, requirements and general expectations from the FDA regarding the importance of submitting information to the ClinicalTrials.gov database .
Recently, the FDA took public action demonstrating its commitment to enforcement. “The transparency of the results of completed clinical studies enables important advances in the development of medical devices and helps ensure a safe, effective and efficient clinical research company,” said Acting FDA Commissioner Janet Woodcock when announcing the first pre-notice of agency non-compliance lawsuit against Acceleron in late April for alleged non-compliance with ClinicalTrials.gov’s compliance requirements.
“Across all types of medical device studies, the [FDA] is working with responsible parties to promote compliance with registration and summary result information submission requirements to ClinicalTrials.gov, which is maintained by the National Institutes of Health (NIH) / National Library of Medicine, Woodcock added.
FDA oversight of ClinicalTrials.gov’s requirements
Join Jung and his colleague Jan Hewett this September when ACRP 2021 resumes with an in-depth look at regulatory trends and compliance. Jung and Hewett will review the definitions and requirements for registering and submitting outcome requests to ClinicalTrials.gov. This session will also outline the FDA’s role in ClinicalTrials.gov compliance and enforcement, as well as an overview of FDA resources available to those involved in ClinicalTrials.gov clinical trials.
View session and program details>
“We hope our session can help clear up any misunderstandings” and make it easier for clinical trial practitioners to understand the unique roles of the FDA and NIH in administering ClinicalTrials.gov, said Hewett.
“Some may understand better than others” about FDA expectations, Jung said. “It is important [share] Results at ClinicalTrials.gov, ”she added, noting that this will help“ drive safer clinical research ”.
Author: Michael Causey