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Sunday, June 20 • 12:00pm - 1:00pm
#537 OD: Using Real-World Data in Single-Arm Trials: When It’s Done, Why It’s Done, How It’s Done

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Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

David Thompson, PhD

Speaker

Application of Real-World Evidence to Support Breakthrough Drug Development
Mark Stewart, PhD

Toward Greater Use of RWD-Based External Controls in Regulatory Decisions: Design and Methods Considerations
Khaled Sarsour, PhD, MPH

Industry Update
Craig White, PhD



Speakers
avatar for David Thompson

David Thompson

Senior Vice President, Real World Research, Syneos Health, United States
David Thompson, PhD is a health economist with 25+ years of experience in HEOR consulting and real-world research design. He currently holds the position of Senior Vice President for Real-World Research at Syneos Health, where he provides RWE design solutions to study sponsors. Dr... Read More →
avatar for Craig White

Craig White

Senior Vice President and Managing Director, Outcomes Science, Concertai, United States
Craig White, PhD, is a researcher with >20 years’ experience in healthcare data and analytics. Craig’s research has covered pharmaceutical pricing methodologies, innovative uses of RWD in clinical development and traditional health economic models and cost-effectiveness analyses... Read More →
avatar for Mark Stewart

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States
Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →
avatar for Khaled Sarsour

Khaled Sarsour

Global Head, RWD Hematology-Oncology, Genentech, A Member of the Roche Group, United States
Khaled Sarsour joined Genentech in 2012 where he currently is the global head of RWE hematology leading a team of multidisciplinary scientists delivering RWE and insights across the phases of drug development. Before joining Genentech, Khaled spent 5 years at Eli Lilly and company... Read More →


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session