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Session 7: Communicating and Estimating the Estimand: the Impact of the Estimand Framework
Session Chair(s)
Mallorie Fiero, PhD
Master Mathematical Statistician, CDER
FDA, United States
Lisa Hampson, PhD
Senior Director, Advanced Methodology & Data Science
Novartis Pharma AG, Switzerland
How to specify and estimate an estimand is not just a statistical question. Close collaboration and effective communication between a variety of stakeholders is essential to ensure the estimand is aligned with the clinical trial objectives, and to align the statistical analyses with the chosen estimand. The estimand thinking process can be used to structure this workflow. At each step, discussions between statisticians and non-statisticians are needed to understand the patient journey as well as the cause and impact of intercurrent events; appreciate which questions are of primary clinical interest; and identify the plausibility of assumptions needed for a statistical analysis. In this session, through discussion and case-studies, we will explore strategies for communicating the estimand framework with clinicians and see examples of how to align the estimator with the estimand.
Learning Objective : - Discuss perspectives of the estimand framework from various stakeholders
- Identify approaches to communicate the estimand framework with clinicians
- Discuss aligning strategies to address intercurrent events and estimators with the estimand
Speaker(s)
Speaker
Shanti V Gomatam, PhD, MS, MSc
FDA, United States
Mathematical Statistician
Journey from Estimand to Estimator
Elena Polverejan, PhD
Johnson & Johnson Innovative Medicine, United States
Scientific Director, Statistical Modeling and Methodology, Statistics and Decisi
Communicating and Aligning Estimands in The ICH E9 (R1) Framework
Craig H. Mallinckrodt, PhD
Biogen, United States
Distinguished Biostatistician
Panelist
Lei Nie, PhD
FDA, United States
Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
Communicating and Estimating the Estimand: the Impact of the Estimand Framework
Anthony Man, DrMed, FRCP
Novartis Pharmaceuticals, Switzerland
Global Clinical Development Head, Communicable Diseases, Global Drug Developmen
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