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Monday, June 28 • 4:00pm - 5:00pm
#150 SL: Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and What We’ve Learned

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-554-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Lauren Hetrick

Speaker

Industry Update
David Hilfiker, MS

FDA Perspective
Leonard Sacks, MD

Industry Update
David Vulcano, MBA, RAC


Speakers
avatar for Lauren Hetrick

Lauren Hetrick

Senior Director, Regulatory Policy and Intelligence, AbbVie, Inc., United States
Ms. Hetrick serves in AbbVie’s Regulatory Policy function where she attends to evolving regulations and policies governing pharmaceutical development issued by the US FDA. She monitors policies in their formative stages, analyzes their impact on the company, informs executive staff... Read More →
avatar for David Hilfiker

David Hilfiker

Senior Director, Bioresearch Quality and Compliance, Janssen R&D, United States
David Hilfiker, Senior Director, Janssen Bioresearch Quality and Compliance, has been a part of Johnson & Johnson Family of Companies since 2005. He currently leads clinical quality planning and strategy for the Janssen Oncology therapeutic area, Established Products, and Medical... Read More →
avatar for Leonard Sacks

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
avatar for David Vulcano

David Vulcano

Honorary President (SCRS); VP, Clinical Research Compliance and Integrity (HCA, HCA Healthcare | Society Clinical Research Sites, United States
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →

Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   09: Regulatory, Session