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DIA 2021 Global Annual Meeting


Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and What We’ve Learned

Session Chair(s)

Lauren  Hetrick

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)

David  Hilfiker, MS

Industry Update

David Hilfiker, MS

  • Senior Director, Bioresearch Quality and Compliance
  • Janssen R&D, United States
Leonard  Sacks, MD

FDA Perspective

Leonard Sacks, MD

  • Associate Director for Clinical Methodology, Office of Medical Policy, CDER
  • FDA, United States
David  Vulcano, MBA, RAC

Industry Update

David Vulcano, MBA, RAC

  • Vice President, Clinical Research Compliance and Integrity
  • HCA Healthcare, United States