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Short Course 3: Implementing the estimand framework in global drug development: Application of causal inference approaches
Time:
Sunday, 03/Sept/2023:
9:00am - 10:30am
Location:Lecture Room U1.141 hybrid
Presentations
Implementing the estimand framework in global drug development: Application of causal inference approaches
Mouna Akacha1, Björn Bornkamp1, Alex Ocampo1, Jiawei Wei2
1Novartis Pharma AG, Basel, Switzerland; 2Novartis Institutes for Biomedical Research Co., Shanghai, China
This half-day short course introduces how causal inference approaches are relevant and used in the implementation of estimands framework in drug development. It includes 4 lectures:
Lecture 1 - Introduction to Estimands and Causal Inference:
Overview of the estimand framework and key points in ICH E9(R1)
Introduction to causal inference, including potential outcomes, causal effects and common assumptions;
Lecture 2 - Estimation Methods of Causal Effects Targeting at Hypothetical Estimands:
Introduction to common estimation methods, e.g., g-computation, IPW (Inverse probability weighting)
RCT examples illustrated using R code;
Lecture 3 - Principal Stratum:
Introduction to principal stratum estimand
Estimation strategies
Case studies in RCTs;
Lecture 4 - Conditional and Marginal Treatment Effects:
Introduction to conditional and marginal treatment effects
Appropriate estimators for conditional and marginal estimands