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Tuesday, June 29 • 4:00pm - 5:00pm
#265 SL: A Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-597-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Susan Mayo, MS

Speaker

Panelist
Niti Goel, MD

Panelist
Miya Okada Paterniti, MD

Panelist
Bohdana Ratitch, PhD, MSc


Speakers
NG

Niti Goel

Adjunct Assistant Professor, Caduceus Biomedical Consulting, United States
Niti Goel, MD, FACR, a board-certified physician-scientist and independent consultant, brings to light the clinical and market potential of new molecules. She has 25 years of academic, clinical development, and medical affairs experience in biotech to pharma and contract research... Read More →
BR

Bohdana Ratitch

Principal Statistician, Bayer, Canada
Bohdana is a Principal Statistician Bayer. She has over 15 years of experience in biopharmaceutical industry including statistical methodology research and consulting, with numerous publications in missing data, estimands, subgroup identification, and machine learning. She is a co-author... Read More →
avatar for Susan Mayo

Susan Mayo

Senior Mathematical Statistician, CDER Office of Biostatistics, FDA, United States
After many years as an industry statistician, Susan joined FDA in 2018 and is now a Senior Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. Susan’s interests in estimands, safety and benefit-risk assessment, and graphics have... Read More →
avatar for Miya Paterniti

Miya Paterniti

Lead Physician, Division of Pulmonology, Allergy, and Critical Care, OND, CDER, FDA, United States
Clinical team leader in the Division of Pulmonology, Allergy, and Critical Care within the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. Received M.D. at the University of Maryland and completed internal medicine residency and fellowship in Allergy and... Read More →

Tuesday June 29, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Forum
  • Beginner Intermediate
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking
  • Tags Forum