2nd Kitasato-Harvard 23/10/2001 Toward Regional Multi-Centered Trials Daisaku Sato Evaluation and Licensing Division Ministry of Health, Labour and Welfare 23 October 2001

2nd Kitasato-Harvard 23/10/2001 Ethnic Experience through E5 Having kept adherent to ICH E5 policy Number of bridging study increasing in Japan Accumulation of experiences must be needed for more comprehensive bridging strategy in Japan. Feed back of successful and unsuccessful cases will be useful. What was clinically significant extrinsic difference?

2nd Kitasato-Harvard 23/10/2001 Transition to the next step Current Circumstances in Japan Newer globally designed products went well. Legacy Problems of bridging the foreign data…… (just examples) –Relatively older foreign data for the review –Unsuccessful trials design/failure in Japan (before E5/ICH-GCP) –Clinical trial disabled in Japan (No. of patients, etc.) Are they defined as “Legacy Drugs”?

2nd Kitasato-Harvard 23/10/2001 Where is ICH - E5 Guideline going? under Changing Global Development Retrospective : – Using data collected in the past – Ambiguity of some definitions that would allow some interpretations e.g. Definition of Asian, Caucasian, Black Prospective : –Promote simultaneous development throughout the world –Need how to design “Global multi-centered Trials” ?

2nd Kitasato-Harvard 23/10/2001 Future of a bridging study toward multi-centered trials Globalisation of development of pharmaceutical products is a reality! Was bridging experience transition to the next step? Could multi-centered trials overcome extrinsic differences? –Do we need to assess magnitude of extrinsic differences in advance? –Could Multi-center trials level the differences? International consensus of why regional trials is needed