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Session 2: ClinicalTrials.gov - Enforcement and Compliance Landscape
Session Chair(s)
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
On April 27, 2021 FDA issued the first ever Notice of Noncompliance to a sponsor for failure to submit the required information to ClinicalTrials.gov. As of April 28, 2021, the agency has also sent Pre-Notices of Noncompliance to more than 40 sponsors to encourage voluntary compliance with the ClinicalTrials.gov requirements. NIH has also notified academic institutions to encourage voluntary compliance.
This session will explore the enforcement and compliance initiatives taken by FDA and NIH to sponsors for failure to submit required information to ClinicalTrials.gov as required by Section 801 of the FDA Amendments Act of 2007. The session will also provide an update of industry’s most recent clinical trial transparency and data-sharing performance.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the current enforcement and compliance disclsoure landscape in the US
- Identify actions taken by FDA and NIH for noncompliance
- Discuss how companies are being evaluated for disclsoure performance
Speaker(s)
Speaker
Jennifer Miller, PHD
Yale School of Medicine, United States
Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics
Speaker
David Peloquin, JD
Ropes & Gray LLP, United States
Senior Advisor, MRCT Center; Associate, Health care Group