JSM 2005 Online Program

Abstract #303835

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	176
Type:	Topic Contributed
Date/Time:	Monday, August 8, 2005 : 2:00 PM to 3:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #303835
Title:	Some Issues in Global Drug Development: From Bridging to Multinational Trials
Author(s):	Yoichi Ii*+
Companies:	Pfizer Japan, Inc.
Address:	Shinjuku Bunka Quint Building, Shibuya ku Tokyo, 151-8589, Japan
Keywords:	global drug development ; multinational trials
Abstract:	ICH efforts have made research and development of new medicines more efficient in terms of time and cost while controlling risks. In particular, the "bridging" concept described in ICH-E5 has been used to extrapolate existing clinical data in one region to another as key evidence in a drug application, thereby avoiding duplications. However, as competitions force drug companies to reduce or eliminate time lag among regions, "simultaneous global development" has become the catch phrase. In such an environment, a trial encompassing multiple countries or regions has gained particular attention in Japan, where such trials involving Japan have been rare. Also, there may be a renewed interest in Western countries, where multinational trials involving Eastern Europe, Asian, and other "unfamiliar" regions are expected to increase. Some issues expected as one moves from bridging to multinational trials will be discussed.

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