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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)
Shanti V Gomatam, PHD, MS, MSC
Mathematical Statistician, FDA, United States
Speaker
Elena Polverejan, PHD
Scientific Director, Statistical Modeling and Methodology, Statistics and Decisi, Johnson & Johnson, United States
Journey from Estimand to Estimator
Craig H. Mallinckrodt, PHD
Distinguished Biostatistician, Biogen, United States
Communicating and Aligning Estimands in The ICH E9 (R1) Framework
Lei Nie, PHD
Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA, United States
Panelist
Anthony Man, DrMed, FRCP
Global Clinical Development Head, Communicable Diseases, Global Drug Developmen, Novartis Pharmaceuticals, Switzerland
Communicating and Estimating the Estimand: the Impact of the Estimand Framework
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