ABSTRACT
The International Conference of Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was embodied in 1990 among three regions: (1) the European Union, including the European Federation of Pharmaceutical Industries’ Association and the European Commission with 15 member countries; (2) the United States, including the Food and Drug Administration and the Pharmaceutical Research and Manufactures of America; and (3) Japan, including the Ministry of Health and Welfare and the Japan Pharmaceutical Manufacturers Association. The purpose of the ICH was to expedite the global development and availability of new medicines to patients without sacrificing safeguards on the medical product’s safety, efficacy, and quality. With this objective, the ICH developed a series of guidelines, aiming to accelerate a greater mutual acceptance of research and development procedures among participating countries. One of these documents, known as E5, entitled “Ethnic Factors in the Acceptability of Foreign Clinical Data” is the basis for the subject of “bridging study,” which was finalized in 1998 as an “ICH Harmonised
CONTENTS
3.1 Introduction .................................................................................................. 31 3.2 Concepts and Structures ............................................................................. 32
3.2.1 Bridging Studies ............................................................................... 32 3.2.2 Global Development via Multiregional Clinical Trial ................ 32
3.3 Common Thread of Statistical Issue: Consistency of Treatment Effects .....................................................................................33 3.3.1 Consistency in Treatment Effect of a Specific
Region of Interest .............................................................................34 3.3.2 Consistency in Treatment Effect among All Regions .................35
