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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S30] lCH E9 (R1): Understand Estimand. Let’s Discuss the Impact on the Design of Clinical Trials

Session Chair(s)

Satoru  Tsuchiya, MSc

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.


Hideki  Suganami, PhD

What is Estimand?

Hideki Suganami, PhD

Kowa Company, Ltd., Japan

Global Data Science Center, Head

Ayako  Hara, MS

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

Takayuki  Imaeda, MPharm, MS

Impact of Estimand from Regulatory and Clinical Viewpoints

Takayuki Imaeda, MPharm, MS

Pfizer R&D Japan, Japan

Head of Regulatory Sciences

Charis  Papavassilis, MD, PhD

Estimands: A Clinical Perspective

Charis Papavassilis, MD, PhD

Novartis Pharma AG, Switzerland

Therapeutic Area Head Therapeutic Area Head

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