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[S39] Utilization of RWD for the Clinical Trial Design and New Drug Application
Session Chair(s)
Takashi Moriya, PHD, MBA
Research Fellow, Keio University, KBS (Keio Business School) Graduate School, Japan
Regulators, industries, and academia have been very interested in how to use Real World Data (RWD) in clinical development. This session will introduce approaches to conducting effective clinical trials using RWD and/or Electronic Health Records (EHRs), and share common current efforts to resolve problems that presently remain for more efficient use of RWD. Database research using RWDs is also actively being considered in Japan. This session will also introduce new clinical trial models in Japan from the viewpoints of industry, government, and academia.
Speaker(s)
Takeharu Yamanaka, PHD
Professor, Department of Biostatics, School of Medicine, Yokohama City University, Japan
Can We Use RWD for Regulatory Decision in Oncology Drug Development?
Tammy Guld, MS
Clinical Innovation Global Team Lead, Janssen Pharmaceuticals, United States
Connected And Enriched Health Data To Optimize Clinical Research Across The Drug Development Cycle
Kinue Nishioka, PHD
Review Director, Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA’s Activities for Regulatory Utilization of Real World Data