Design and Analysis of Multinational Clinical Trials

Abstract

In recent years, multinational multicenter trials have become increasingly popular for evaluation of the generalizability of clinical results across different countries. With the implementation of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP), multinational trials have become widely accepted by most regulatory agencies including the United States Food and Drug Administration. As indicated by Suwelack and Weihrauch (1), however, some difficulties are often encountered in multinational trials. These difficulties, which are primarily due to differences in culture, medical practice, regulatory requirements, and drug management have a negative impact on the integrity of the multinational trial. In this paper, it is suggested that all possible causes (both expected or unexpected) of bias and variability that may occur during the conduct of a multinational trial be identified, eliminated/removed, or controlled whenever possible to ensure the success of the multinational trial. Some practical issues regarding the design and analysis of a multinational trial are also addressed.