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Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework
Session Chair(s)
Marian Mitroiu, PhD
Associate Director Biostatistics
Biogen, Switzerland
This session will include short presentations delivered by speakers from three Regulatory Agencies sharing perspectives based on their own experience with the ICH E9(R1) estimand framework implementation. The session participants will have the opportunity to engage with the speakers in a 25-minute open discussion, fueled by a few survey questions.
Learning Objective : Highlight how scientific questions of interest from different stakeholders require different strategies for the intercurrent event of new anti-cancer medication; discuss implications for the trial design and decision-making; emphasize the importance of the specific mechanism bringing about the hypothetical scenario, when determining whether the use of a hypothetical strategy is reasonable. Illustrate how in some settings the use of a hypothetical scenario may not be appropriate.
Speaker(s)
EMA Update
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
FDA Update
Cesar Daniel Torres, PhD, MS
FDA, United States
Senior Mathematical Statistician, OB, OTS, CDER
MEB Update
Laura Rodwell, PhD
Dutch Medicines Evaluation Board, Netherlands
Statistical Assessor
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