Menu Back toA Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation

DIA 2021 Global Annual Meeting

A Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation

Session Chair(s)

Susan Mayo, MS

Susan Mayo, MS

  • Mathematical Statistician, OB, DB3, OTS, CDER
  • 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)

Niti Goel, MD

Panelist

Niti Goel, MD

  • Adjunct Assistant Professor
  • Caduceus Biomedical Consulting, United States
Miya Okada Paterniti, MD

Panelist

Miya Okada Paterniti, MD

  • Lead Physician, Division of Pulmonology, Allergy, and Critical Care, OND, CDER
  • FDA, United States
Bohdana Ratitch, PhD, MSc

Panelist

Bohdana Ratitch, PhD, MSc

  • Principal Statistician
  • Bayer, Canada