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TFT Halls & Rooms

Nov 06, 2013 9:00 AM - Nov 08, 2013 6:00 PM

TFT Building, 3-6-11 Ariake, , Koto-ku,, Tokyo, 135-8071 Japan

10th Annual Meeting DIA Japan 2013

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Session 2 / Venue 6: Drug Evaluation with Small 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

In the process of developing medical products, statistical hypothesis testing is generally performed in the phase III trial. However, there is a case when limited numbers of patients are available to the study within a reasonable time frame for the purpose of the statistical testing. Such clinical studies are defined as small clinical trials (SCTs). Examples of constraints that lead to a SCT include, but not limited to, 1.) rare disease, where the target population is very small, 2.) clinical assessment with big burden for patients, 3.) pediatric disease, where recruiting large number of patients is very difficult, and 4.) target population of the trial is disease with specific genetic mutation. Recently, SCTs have been widely conducted, so being able to conduct them with scientific rigor is of increasing importance. In this session, presenters from industry, government and academia will provide the points to consider evaluating medical products with SCTs.

Speaker(s)

Hideki Suganami, PhD

Drug Development and Evaluation with Small clinical Trials from the regulatory Point of view

Hideki Suganami, PhD

Kowa Company, Ltd., Japan

Global Data Science Center, Head

Harumasa Nakamura, MD, PhD

Drug Development and Evaluation with Small Clinical Trials from the Regulatory Point of View

Harumasa Nakamura, MD, PhD

National Center of Neurology and Psychiatry, Japan

Director of Department of Clinical Research Support,

Takeharu Yamanaka, PhD

Design of Clinical Trials for Rare Cancer in Europe and America

Takeharu Yamanaka, PhD

Yokohama City University, Japan

Professor, Department of Biostatics, School of Medicine

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