The adoption by countries of recommendations from the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) has set the stage for important advances in drug evaluation worldwide. In particular, the E5 guidelines--issued in August 1998--allow data resulting from clinical studies done in the West to be used by regulators in other parts of the world, including Japan, for consideration in the approval of drugs in their own countries. More generally, the ICH recommendations raise the specter of global clinical trials in which one or more international studies could be used for registration of a pharmaceutical in multiple nations.

From a technical perspective, many questions remain regarding how best to use and to augment the results from external studies of a drug in order to know whether and how it should be registered in a different area. The Kitasato University-Harvard School of Public Health Symposium on ﾒGlobal Drug Development Techniques: Bridging Strategiesﾓ was intended to address a variety of topics relating to bridging strategies. Because of the global nature of the issues to be discussed, it was felt to be important the both Eastern and Western perspectives are elucidated.

It is our hope that this initial symposium will stimulate further discussion, collaboration, and research on methods for global evaluation of drugs.