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[S30] lCH E9 (R1): Understand Estimand. Let’s Discuss the Impact on the Design of Clinical Trials
Session Chair(s)
Satoru Tsuchiya, MSc
Senior Director, Global Data Design Office
JPMA (Japan Pharmaceutical Manufacturers Association)/Sumitomo Pharma, Co., Ltd., Japan
The ICH E9 (R1) guideline will be step 4 in 2019. Estimand dealt with in the guideline is an important concept in the design of the clinical trials, and it is necessary for non-statistician to understand the guideline. How does the 18 protocol of clinical trials change and how should the results be interpreted? For non-experts in statistics, explain estimand in an easy-to-understand manner, and share real examples, discuss and points to consider on this topic.
Speaker(s)
What is Estimand?
Hideki Suganami, PhD
Kowa Company, Ltd., Japan
Global Data Science Center, Head
Expectation on Future Implementation of E9(R1) Guideline
Ayako Hara, MS
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Biostatics Reviewer, Office of New Drug III
Impact of Estimand from Regulatory and Clinical Viewpoints
Takayuki Imaeda, MPharm, MS
Pfizer R&D Japan, Japan
Head of Regulatory Sciences
Estimands: A Clinical Perspective
Charis Papavassilis, MD, PhD
Novartis Pharma AG, Switzerland
Therapeutic Area Head Therapeutic Area Head