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[V6-S6] Evidence Generation under Japan’s New Clinical Trials Act
Session Chair(s)
Shinzo Hiroi, PHD, MPH, RPH, PMP
Senior Director, Project Management, IDC ICO Real World Solutions, ICON Clinical Research GK, Japan
It would become more complicated to conduct interventional studies due to new clinical trials act, effective in April 2018 in Japan. The importance of observational studies has been focused to generate the medical evidence originated from Japan. In this session, the advantages and limitations of observational studies will be discussed, compared with those of interventional studies.
Speaker(s)
Akihito Uda, MPH
Health Economics & Outcome Reserch, Value & Access Division, Novartis Pharma K.K., Japan
Case Studies of Real World Evidence in HEOR of Pharmaceutical Industry
Koji Iwasaki, PHD
Professor, Academic Clinical Research Center, , Osaka University Hospital, Japan
Impact of Clinical Trial Act on Generating Medical Evidence
Hisashi Urushihara, DrPH
Professor, Faculty of Pharmacy, Department of Pharmacy, Keio University, Japan
Basics of Observational Study