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16th DIA Japan Annual Meeting 2019
[S30] lCH E9 (R1): Understand Estimand. Let’s Discuss the Impact on the Design of Clinical Trials
Satoru Tsuchiya, MSc
- Senior Director, Global Data Design Office
- Sumitomo Dainippon 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.
What is Estimand?
Hideki Suganami, PhD
- Director, Clinical Data Science Dept.
- Kowa Company, Ltd., Japan
Expectation on Future Implementation of E9(R1) Guideline
Ayako Hara, MS
- Biostatics Reviewer, Office of New Drug III
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Impact of Estimand from Regulatory and Clinical Viewpoints
Takayuki Imaeda, MPharm, MS
- Senior Director, Regulatory Affairs
- Pfizer R&D Japan, Japan
Estimands: A Clinical Perspective
Charis Papavassilis, MD, PhD
- Therapeutic Area Head Therapeutic Area Head
- Novartis Pharma AG, Switzerland