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[S19] A New and Optimal Collaboration with Companies in Investigator Initiated Trials Using Government Platform
Session Chair(s)
Keiichi Fujiwara, MD, PHD
Professor, Department of Gynecologic Oncology Chief, Saitama Medical University International Medical Center, Japan
New drug approval is made by huge investment by companies. On the other hand, academic clinical trials are mostly conducted based on public funds, but the opportunities and resources are limited. Recently, clinical trials supported by companies have become widespread as contract research, but The quality and procedure of these trials varies a lot. Most investigator initiated and multicenter trials are conducted based on cooperative groups or clinical trial networks. In this session, we share the experience of performing international investigator initiated indication-directed or academic clinical trials, in collaboration between companies and academia in clinical trials groups in Japan, the US (with NCI initiative) and Europe (with trial network), and will discuss the optimal future direction of the relationship between industry-government-academia.
Speaker(s)
Keiichi Fujiwara, MD, PHD
Professor, Department of Gynecologic Oncology Chief, Saitama Medical University International Medical Center, Japan
Background and the Purpose of the Session
Elise C. Kohn, MD
, National Cancer Institute, NIH, HHS, United States
History and Current Situation in the US- Government Perspective [Recorded Presentation]
Robert L. Coleman, MD
Professor of Department of Gynecologic Oncology and Reproductive Medicine, Div, University of Texas MD Anderson Cancer Center, Houston, TX, United States
Collaboration for International Multi-Center Clinical Trials: Academia perspective [Web Presentation]
J. Michelle Brockman, MBA
Principal Medical Science Director--NCI--National Clinical Trial Network and Sci, Genentech BioOncology , United States
Collaboration for International Multi-Center Clinical Trials: Industry perspective [Web Presentation]
Masayoshi Naruoka, MBA
Project Leader, AstraZeneca K.K., Japan
Collaboration for International Multi-Center Clinical Trials Values and Challenges for industry perspective