Welcome and Introduction

David Shurtleff, PhD
Richard Hodes, MD
Catherine Meyers, MD
Wendy Weber, PhD, MPH

Panel 1: Partnering With Stakeholders to Conduct Embedded A vs. B Trials: Keys to Success

Moderator: Rich Platt, MD, MSc

Panel:

• • Steve Friedhoff, MD
  • Kenneth Sands, MD, MPH
  • Joseph Chin, MD

Panel 2: Examples in Action: Embedded A vs. B Trials

Moderator: Beverly Green, MD, MPH

Panel:

• • Ryan Ferguson, ScD, MPH
  • Susan Huang, MD, MPH
  • Michael Kappelman, MD, MPH

Panel 3: Maximizing the Pragmatic: Understanding Approaches to Design of Embedded A vs. B Trials

Moderator: Greg Simon, MD, MPH

Panel:

• • Scott Solomon, MD
  • Rachael Fleurence, PhD
  • Kourtney Davis, PhD, MSPH

Panel 4: Regulatory Aspects of Clinical Research and the Regulation of Products for Embedded A vs. B Pragmatic Trials

Moderator: Adrian Hernandez, MD

Panel:

• • Jacqueline Corrigan-Curay, MD, JD
  • Owen Faris, PhD
  • Julie Kaneshiro, MA

Panel 5: Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trials Moderator:

Moderator: David Wendler, PhD

Panel:

• • Barbara Bierer, MD
  • Spencer Hey, PhD
  • Judith Carrithers, JD, MPA

Summary and Concluding Remarks

Moderator: Cathy Meyers, MD

Panel:

• • Adrian Hernandez, MD
  • Rich Platt, MD, MSc
  • Beverly Green, MD, MPH
  • Greg Simon, MD, MPH
  • Dave Wendler, PhD