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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V4-S3] New Methods to Clinical Evaluation of Anticancer Drugs in the Era of Immune Oncology Therapy

Session Chair(s)

Yasuhiro  Fujiwara, MD, PhD

Yasuhiro Fujiwara, MD, PhD

Chief Executive

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Immnuno-Oncology (I-O) is really a unique and innovative approach to treat cancer patients. And, I-O agents pose unique challenges to the design of clinical trial as the treatment effect may be delayed. Thus, several statistical approaches have been developed to address the violation of proportional hazard assumption. In this session, a comprehensive summary for such approaches including the use of the restricted mean survival time (RMST) will be provided from not only statistical but also clinical perspectives. Finally, this session will provide a comprehensive discussion of the clinical evaluation of I-O. We will also discuss appropriateness of the clinical endpoints, the determination of development strategies, and the patient early access to new drugs as the treatment system evolves significantly regardless of I-O.


Toshio  Shimizu, MD, PhD

Clinical Questions and Application of Restricted Mean Survival Time for Immuno-oncology Clinical Trials

Toshio Shimizu, MD, PhD

National Cancer Center Hospital, Japan

Head of Physician (Oncology Phase 1 Unit), Dept of Experimental Therapeutics

Takeharu  Yamanaka, PhD

Evaluating Survival Efficacy of Immunotherapy

Takeharu Yamanaka, PhD

Yokohama City University, Japan

Professor, Department of Biostatics, School of Medicine

Takahiro  Hasegawa, DrPH

Restricted Mean Survival Time as Summary Measure of Time-to-Event Outcome

Takahiro Hasegawa, DrPH

Shionogi & Co., Ltd., Japan

Section Head of Biostatistics 1 in Biostatistics Center

Takahiro  Nonaka, PhD

Takahiro Nonaka, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Head of Epidemiology, Medical information Division