Drug Evaluation Committee Preliminary Study of AI Application to Quality Management in Clinical Trials - Aiming to Foster a Quality Culture with AI as a Companion
Data Science Expert Committee
December 2025
The JPMA DS Subcommittee has conducted and published the results of several AI prototyping studies in FY2022 and FY2023. This deliverable is a sequel to those prototypes. Since the publication of ICH E6 (R3) Step 4 was approaching at the time when the study started, the following two prototypes were conducted with a focus on "how AI can contribute to quality management of clinical trials".
- Assistance in identifying Critical to Quality Factors
- Detection of Critical to Quality Factors based on study protocol
Through these studies, the usefulness of AI in clinical trial quality management was suggested, and the importance of Human-in-the-Loop was reaffirmed. Furthermore, the effectiveness of a collaborative system with AI and humans sharing roles was also demonstrated.
This study is an example of a practical attempt to incorporate AI into clinical trial operations. This document is also a record of the process of the authors' trial-and-error study, allowing the reader to follow the contents of the study and the flow of thought that led up to the compilation of the results.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee Task Force 1-2 for FY2024