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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
  • 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.

Speaker(s)

Hideki  Suganami, PhD

What is Estimand?

Hideki Suganami, PhD

  • Director, Clinical Data Science Dept.
  • Kowa Company, Ltd., Japan
Ayako  Hara, MS

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
Takayuki  Imaeda, MPharm, MS

Impact of Estimand from Regulatory and Clinical Viewpoints

Takayuki Imaeda, MPharm, MS

  • Senior Director, Regulatory Affairs
  • Pfizer R&D Japan, Japan
Charis  Papavassilis, MD, PhD

Estimands: A Clinical Perspective

Charis Papavassilis, MD, PhD

  • Therapeutic Area Head Therapeutic Area Head
  • Novartis Pharma AG, Switzerland