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[V3-S5] Changing Landscape of Phase I Trials in Oncology
Session Chair(s)
Akihiro Hirakawa, PHD
Professor, Department of Clinical Biostatistics, Institute of Science Tokyo, Japan
The role of phase I trial is changing to streamline cancer clinical development. It is common to carry out a dose escalation trial using 3 + 3 design, but in recent years various novel designs including global phase 1 trials are drawing attention. By knowing various options related to phase 1 trials, development strategies can be optimized. In this session, we will discuss on the novel designs, multiregional phase 1 trial, and phase 1 trials based on the characteristic of investigational drug.
Speaker(s)
Akihiro Hirakawa, PHD
Professor, Department of Clinical Biostatistics, Institute of Science Tokyo, Japan
Changing Landscape of Phase I Trials in Oncology: Overview
Tomoyuki Kakizume, PHD
, Daiichi Sankyo Co., Ltd., Japan
Points to be Consider when Joining Multi-Regional First-In-Human Studies in Oncology
Tomohiro Tanaka, MS
Group Manager, Clinical Science & Strategy Department, Chugai Pharmaceutical Co., Ltd., Japan
Strategic Phase I Trials based on the Characteristic of Investigational Drug
Hiroyuki Sato, PHD
Reviewer, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA Perspective
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