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[V4-S3] New Methods to Clinical Evaluation of Anticancer Drugs in the Era of Immune Oncology Therapy
Session Chair(s)
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.
Speaker(s)
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
Evaluating Survival Efficacy of Immunotherapy
Takeharu Yamanaka, PhD
Yokohama City University, Japan
Professor, Department of Biostatics, School of Medicine
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
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Head of Epidemiology, Medical information Division