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Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance
Session Chair(s)
Yongman Kim, PHD
Lead Mathematical Statistician, OB, OTS, CDER
FDA, United States
Describe ongoing pilot efforts by statistical and clinical reviewers at FDA to create ‘default’ estimands for different therapeutic areas. Clinical and statistical teams’ experience on estimands in pulmonary-allergy and other areas will be discussed.
Learning Objective : Discuss the Agency’s pilot experiences and opinions on estimands in a few clinical settings from the regulatory perspective; Demonstrate the value to statisticians and clinicians for clearly understanding medical questions by defining appropriate estimands.
Speaker(s)
Estimands and ICH E9 (R1): Adoption and Challenges - 3 Years Later
Munish Mehra, PHD, MS, MSC
Quantum Biopharma, United States
Managing Director and Sr. Principal Biostatistician
Estimands Approach Taken in Analgesia and Thoughts for the Future
David M. Petullo, MSC
FDA, United States
Mathematical Statistician, OB, OTS, CDER
Why Clinicians are Interested in Estimands: How it Helps Their Reviews and What They Wish to Achieve
Rekha Jhamnani, MD, MSC
FDA, United States
Medical Officer, DNPDI, OND, CDER
Estimands Approach Taken in Pulmonology-Allergy-Critical Care Statistics at CDER FDA
Susan Mayo, MS
FDA, United States
Senior Mathematical Statistician, CDER Office of Biostatistics