10th annual meeting of the Japan Society of Clinical Pharmacological Studies

摘要

The 10th annual meeting of the Japan Society of Clinical Pharmacological Studies focused on four issues on clinical trials to promote drug development in Japan.Individual differences in drug metabolism among patients/subjects in clinical trials, ethics committees on clinical trials, multi-country and multi-center clinical trials, and topics on microdose clinical trials were presented by 12 speakers and discussed to encourage clinical trials for development of new drugs in Japan.Genetic approaches were useful to clarify the etiology of the individual differences in drug metabolism and effects among patients/subj ects. Two issues were taken as topics of the ethics committee. Genetic analysis in clinical trials can be examined by the IRB, instead of committees on genetics. Two committees, epidemiological and research committees overlapped at many points and should be integrated into one committee. Multi-country and multi-center clinical trials should be done in Japan with other countries, especially with Asian countries to promote the development of new drugs. The patients/subjects panels can be enlarged by establishing alarge research group by integrating several clinics or hospitals. The results of clinical trials should be published in international journals. Microdose clinical trials are a new strategy for clinical trials for drug development. PET scan studies are applied to clarify the distribution and concentration of drugs using this new technique.