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DIA 2021 Global Annual Meeting

Using Real-World Data in Single-Arm Trials: When It’s Done, Why It’s Done, How It’s Done

Session Chair(s)

David Thompson, PhD

David Thompson, PhD

  • Chief Executive Officer for Health Evidence and Access
  • OPEN Health, United States
As real-world data increasingly provide synthetic controls in single-arm drug registration studies, terminology and insights have evolved. The structured, multistep assessment process described addresses why, when, and where to use new approaches.
Learning Objective : Describe fundamentals of synthetic control arms and real-world data integration into clinical trials; Discuss relevant key terminology; Evaluate feasibility of using an external control arm in a clinical trial; Identify how to weigh pros and cons of historical versus concurrent control arm data; Identify potential external sources for control populations.

Speaker(s)

Mark Stewart, PhD

Application of Real-World Evidence to Support Breakthrough Drug Development

Mark Stewart, PhD

  • Vice President, Science Policy
  • Friends of Cancer Research, United States
Khaled Sarsour, PhD, MPH

Toward Greater Use of RWD-Based External Controls in Regulatory Decisions: Design and Methods Considerations

Khaled Sarsour, PhD, MPH

  • Global Head, RWD Hematology-Oncology
  • Genentech, A Member of the Roche Group, United States
Craig White, PhD

Industry Update

Craig White, PhD

  • Senior Vice President and Managing Director, Outcomes Science
  • Concertai, United States