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Ethnic Difference in Clinical Trial Data: A 15-Year History of an Investigation by Regulatory Agencies and Industry
Session Chair(s)
Akio Uemura, PHD
Senior Advisor, AU Consulting, Co., Japan
Ethnic factors are very important in considering utilization of clinical data generated in population mixture. In this session, we will try to understand the current regulations of handling ethnic differences/similarities in clinical trial data by reflecting on ICH E5 utilization and explore future clinical trials aiming for global drug development with a particular focus on East Asian clinical trials.
Learning Objective : Review scientific evidences which show or do not show acceptability of clinical data with ethnic differences; Review history of the regulations and current understanding in accepting clinical trial data generated in foreign populations; Describe future international regulations for handling ethnic factors.
Speaker(s)
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ethnic Similarities and Differences: Facts and Interpretations
In-Jin Jang, MD, PHD
Professor, College of Medicine, Seoul National University, Korea, Republic of
Utilization of Asian Clinical Trial Data for Drug Development in Korea: Investigator’s Perspective
Chwen-Cheng Chen, MD, PHD
CEO, JN Biopharma Consulting, United States
New Drug Application in China: Value of Foreign Data
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