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Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data
Session Chair(s)
Munish Mehra, PhD, MS, MSc
Senior Principal Biostatistician and Executive Director Biometrics
Tigermed, United States
Industry and FDA experts will share how to operationalize ICH E9(R1) to design trials with clinically meaningful endpoints. Forum will include a summary from the DIA Stats Community GTQR Series, the Oncology Drug Development Working group on Estimands, and Tipping Point analysis to account for missing data.
Learning Objective : Discuss key elements of ICH E9(R1) and GTQR; Define estimands and ongoing efforts for implementation; Identify how to apply estimands in oncology with time-to-event endpoint; Describe an overview and examples of applying tipping point analysis to explore the impact of missing data assumptions on study results, along with key considerations during the planning stage of these sensitivity analyses.
Speaker(s)
Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry-Wide Working Group
Yi Liu, PhD
Nektar Therapeutics, United States
Vice President, Biometrics
Assessment of Tipping Point Analysis for Handling Various Types of Missing Data
Martin Clancy, MSc
PHASTAR, United Kingdom
Senior Statistician
Estimands for Efficacy Analyses
Thomas J. Permutt, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
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