薬理と治療

Abstract

Background Medical innovation is based on research that ultimately must include studies involving human subjects. Adverse event reporting（AER）is one of the most fundamental mechanisms in clinical trials to detect signals for possible causal relationships. Objectives To clarify the roles and responsibilities to conduct multi‒center clinical trials in Japan. Methods We have identified relevant Japanese guidance documen（t s）on ethical and scientific quality standard for designing, conducting, recording, and reporting trials, to be compared with the internationally harmonized good clinical practice（ICH‒GCP）. An internationally harmonized method for regulatory science, the GCP‒comparison, has been applied to analyze definitions and appropriate handlings of AER in the guidance documents for investigator‒initiated clinical investigations. Results There are some administrative and minor differences, but no major differences have been identified between the ICH‒GCP and the new Japanese guidance. Conclusions The new Japanese guidance seems to be carefully prepared enough to conduct global clinical trials more easily. It is critically important to establish standardized operational procedures for unknown AER, when supporting the roles and responsibilities of the study investigator, the site investigators, as well as the site directors.