Japanese guideline for clinical research of antimicrobial agents on urogenital infections: the first edition

Abstract

In the 1970s, clinicians and researchers specializing in urinary tract infections (UTIs) established and published the first-ever Criteria for Clinical Evaluation of Drug Efficacy on UTI. There had so far been no uniform criteria for the evaluation of drug efficacy, and different criteria for determining drug efficacy had been used in the development of drugs, which had caused problems in determining drug efficacy and had made it impossible to compare efficacy between drugs. To resolve these challenges, the Criteria for Clinical Evaluation of Drug Efficacy on UTI were established on the basis of the results of a large number of studies. The late Dr. Masaaki Ohkoshi, the late Dr. Joji Ishigami, the late Dr. Tsuneo Nishiura, Dr. Toyohei Machida, Dr. Yoshiaki Kumamoto, Dr. Joichi Kumazawa, Dr. Yukimichi Kawada, Dr. Sadao Kamidono, and other senior physicians made efforts to create the world’s first Criteria for Clinical Evaluation of Drug Efficacy on UTI, which had contributed enormously to the development of antimicrobial agents for UTIs. In 1989, an International Symposium entitled ‘‘Clinical Evaluation of Drug Efficacy on UTI’’ was held in Tokyo and offered opportunities to get international recognition of the Criteria for Clinical Evaluation of Drug Efficacy on UTI. Thereafter, the International UTI Symposium was established and came to be held biennially in conjunction with the International Congress on Chemotherapy. The joint symposium has been held ten times to date. In Japan, the Criteria for Evaluation of Clinical Efficacy of Antimicrobial Agents on UTI were created by the UTI study group. The Criteria, which were those of the revised 3rd edition, involved various urological infections, including prostatitis, epididymitis, and urethritis, in addition to UTIs. Meanwhile, Infectious Diseases Society of America (IDSA)/ Food and Drug Administration (FDA) guidelines and the Criteria for Clinical Evaluation of Drug Efficacy were established in theUnitedStates andEurope, respectively,which led to an increased need for international harmonization aswell as globalization of the development of antimicrobial agents. To move with the times and to allow compatibility between data accumulated in Japan and data fromother countries, the Study Group on Urology, the Committee of Clinical Evaluation Methods, and the Japanese Society of Chemotherapy discussed and created the 4th edition of Criteria for Evaluation of Clinical Efficacy of Antimicrobial Agents on UTI (tentative) and its supplement in 1996. However, further international harmonization was needed, as international drug development, extrapolation of clinical data from other countries, and bridging studies had been increasing. In bringing about international M. Yasuda S. Takahashi H. Kiyota K. Ishikawa A. Takahashi S. Yamamoto S. Arakawa K. Monden T. Muratani R. Hamasuna H. Hayami T. Matsumoto UTI Subcommittee of the Clinical Evaluation Guidelines Committee, Japan Society of Chemotherapy, Tokyo, Japan