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[V3-S5] Changing Landscape of Phase I Trials in Oncology
Session Chair(s)
Akihiro Hirakawa, PhD
Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
Tokyo Medical and Dental University, 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)
Changing Landscape of Phase I Trials in Oncology: Overview
Akihiro Hirakawa, PhD
Tokyo Medical and Dental University, Japan
Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
Points to be Consider when Joining Multi-Regional First-In-Human Studies in Oncology
Tomoyuki Kakizume, PhD
Takeda Pharmaceutical Co. Ltd.,, Japan
Statistical & Quantitative Sciences
Strategic Phase I Trials based on the Characteristic of Investigational Drug
Tomohiro Tanaka, MS
Chugai Pharmaceutical Co., Ltd., Japan
Group Manager, Clinical Science & Strategy Department
PMDA Perspective
Hiroyuki Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug V