Statistical Issues of Worldwide Simultaneous Clinical Drug Development —Introduction—

Abstract

This article aims to give a brief review of current drug development procedures and issues which were to be discussed in the biostatistics seminar which was held on 19, December 2010 in Kobe. A few typical global development plans for clinical development of a new drug are presented. These plans use the bridging concept and multiregional trials. It is necessary to take several factors into account when we plan global development of a new drug. Points to be discussed are given below: 1) definition of regions, 2) how to look at similarity of response to drugs among different ethnic groups, and how to measure the similarity of trial results? 3) definition of the treatment main effect, 4) design of a multiregional trial and how to allocate sample sizes to regions, 5) how to evaluate the effect of covariates and ethnic factors, 6) statistical persuasiveness of the trial results, 7) evaluation of consistency of the quality of a trial among regions, 8)cross-cultural reliability of rating scales, 9) evaluation of safety, 10) relationships between exploration and confirmation.