Dr. M. Iwasaki 1 Asian Multinational Clinical Trials - Current Status & Future Direction - Dr.Masaru IWASAKI PR Japan Operations Center Aventis Pharma, Ltd.
Dr. M. Iwasaki 2 New Trend for Asian Study New Regulatory Environment for CT Implementation of ICH-GCP Introduction of Bridging Study Preparation at Medical Sites Establishment of high-quality Clinical Research Center Extensive training for Investigators Collaborating work with industry Improvement of the Infrastructure Active operation of Western and Japanese CROs Establishment of SMO
Dr. M. Iwasaki 3 Asian Multinational Study - Current Status - 1, Japan Involvement in Asian Studies - Currently only one execution of MCT with Korea - Several consultations with regulatory authorities - Many companies ; investigated or under investigation - Study phase ; mainly Phase 2-3, some in Phase I - Main expected partner ; Korea, Taiwan, China 2, Singapore-based Asian Study - Establishment of Clinical Development Center - Establishment of operation center of CROs - Regulatory support for the active operation of CT - Broader covering countries ; Philippine, Australia, India, … -
Dr. M. Iwasaki 4 Issues for Asian Study A, Variability in Medical/Social Environment - Ethnicity and Epidemiology - Medical Practice and Healthcare System B, Medical and Institutional Factors - Number of Qualified Institutes / Investigators - Understanding/Acceptance of CT - Administrative/Medical Support at Institutes C, Sponsor’s Development Strategy - Basic Strategy of Global Development D, Operational Factors - Language and Communication - Standardization of Systems & Processes - QC/QA and Auditing/Inspection - Logistics of Drug Supply
Dr. M. Iwasaki 5 Future Direction of Asian MCT ► Impact of Bridging Study in Japan → Reduction of study size → No urgent needs of Asian Study ► Bridging Study in other Asian Countries - With Western data? - With Japanese data? Future Direction of Asian MCT - Generation of Asian data for Global simultaneous development