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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.


Session 7: Communicating and Estimating the Estimand: the Impact of the Estimand Framework

Session Chair(s)

Mallorie  Fiero, PhD

Mallorie Fiero, PhD

  • Lead Mathematical Statistician, CDER
  • FDA, United States
Lisa  Hampson, PhD

Lisa Hampson, PhD

  • 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

Speaker

Shanti V Gomatam, PhD

  • Mathematical Statistician
  • FDA, United States
Elena  Polverejan, PhD

Journey from Estimand to Estimator

Elena Polverejan, PhD

  • Scientific Director, Statistical Modeling and Methodology, Quantitative Sciences
  • Janssen Pharmaceuticals, United States
Craig H. Mallinckrodt, PhD

Communicating and Aligning Estimands in The ICH E9 (R1) Framework

Craig H. Mallinckrodt, PhD

  • Distinguished Biostatistician
  • Biogen, United States
Lei  Nie, PhD

Panelist

Lei Nie, PhD

  • Associate Director, Division of Biometrics II, Office of Biostatistics, OTS, CDE
  • FDA, United States
Anthony  Man, DrMed, FRCP

Communicating and Estimating the Estimand: the Impact of the Estimand Framework

Anthony Man, DrMed, FRCP

  • Global Clinical Development Head, Communicable Diseases, Global Drug Developmen
  • Novartis Pharmaceuticals, Switzerland