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A Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation
Session Chair(s)
Susan Mayo, MS
Senior Mathematical Statistician, CDER Office of Biostatistics
FDA, United States
The importance of alignment of the clinical question to the trial design and analysis cannot be underestimated. Via examples, this session will cover sponsor and regulatory viewpoints on the estimand framework, a tool that aligns these aspects.
Learning Objective : Describe the estimand framework from ICH E9(R1); Distinguish roles and highlight the importance of collaboration of clinicians and statisticians in construction of estimands; Demonstrate how the estimand framework improves alignment of the clinical question in trial design, conduct, analysis, and clinical interpretation via examples using several therapeutic area examples.
Speaker(s)
Panelist
Niti Goel, MD
Caduceus Biomedical Consulting, United States
Adjunct Assistant Professor
Panelist
Miya Okada Paterniti, MD
FDA, United States
Lead Physician, Division of Pulmonology, Allergy, and Critical Care, OND, CDER
Panelist
Bohdana Ratitch, PhD, MSc
Bayer, Canada
Principal Statistician