2025 年 42 巻 1 号 p. 19-24
Good Clinical Practice (GCP) is a set of standards to ensure clinical trials' scientific and ethical conduct. GCP was first introduced in Japan in 1989, but initially, it was not legally binding and caused many problems. Subsequently, in 1996, international standardization efforts led to the formulation of ICH–GCP, which was also introduced into Japanese regulations. This movement strengthened the rules governing the conduct of clinical trials. ICH–GCP became an essential guideline for improving the quality of clinical trials in Japan and around the world. However, the existing GCP could not adequately respond to the drastically changing clinical development environment for pharmaceuticals, and revising the GCP began in 2013. ICH–E6 (R2) introduced new concepts regarding quality management and monitoring. Furthermore, in 2017, ICH published a new proposal called “GCP Renovation” to address the diversification of clinical trial designs and data sources. Based on this proposal, ICH developed ICH–E8 (R1) and ICH–E6 (R3), introducing a new approach to quality management in clinical trials. In particular, the concept of Quality by Design (QbD) was emphasized, and efforts to improve quality from the planning stage of clinical trials are essential. Quality management in clinical trials is expected to improve trial efficiency and reliability by introducing risk–based approaches (RBA) and QbD. The entire process ensures that clinical trial deliverables meet expected standards. Clinical Researchers should set different quality standards for each trial and conduct ongoing quality control to meet those standards.
