Clinical Trials Review Anti-infectives: Clinical trials of antimicrobials for urinary tract infections

Abstract

Clinical trials of new anti-infectives for urinary tract infection commenced with a complete lack of correlation between countries, to the extent that drugs actually on sale in Japan were, nonetheless, put through a complete set of trials before registration elsewhere. Even now, the regulatory bodies in different countries have differing requirements. Following the initiative from Japan, a series of International Symposia on the Clinical Evaluation of Drug Efficacy in Urinary Tract Infections has been held to discuss the problems involved in developing an international approach to trials. The problems have been discussed fully at the three meetings, and it is encouraging to note a gradually increasing international consensus between regulatory bodies. This paper describes the problem from the standpoint of an investigator.