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Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and What We’ve Learned
Session Chair(s)
Lauren Hetrick
Senior Director, Regulatory Policy and Intelligence
AbbVie, Inc., United States
There were unprecedented challenges associated with conducting clinical trials during COVID-19. This session will explore how sponsors and HAs worked together to address these issues and continue efforts to develop medical products and the lessons learned from making those adaptations. The session will also consider adaptations that may be applicable to trials post-pandemic.
Learning Objective : Describe how COVID-19 impacted randomized controlled trials (RCTs) including examples of deviations from study protocols; Discuss how sponsors interacted with Health Authorities to maintain awareness of protocol deviations and receive guidance on planned modifications; Identify the best practices that were learned and how we can apply them to future trials.
Speaker(s)
Industry Update
David Hilfiker, MS
Janssen R&D, United States
Senior Director, Bioresearch Quality and Compliance
FDA Perspective
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
Industry Update
David Vulcano, MBA, RAC
HCA Healthcare | Society Clinical Research Sites, United States
Honorary President (SCRS); VP, Clinical Research Compliance and Integrity (HCA