Drug Evaluation Committee Preliminary Study on Application of AI to Quality Management of Clinical Trials - Aiming to Foster Quality Culture with AI as a Companion
Data Science Subcommittee
December, 2025
The DS Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) has conducted multiple AI prototyping projects in FY2022 and FY2023 and published the results. 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 the quality management of clinical trials".
- Support for Identification of Critical to Quality Factors
- Detection of Critical to Quality Factors based on study protocol
Through these studies, the usefulness of AI in managing the quality of clinical trials was suggested, and the importance of Human-in-the-Loop was reaffirmed. Furthermore, the effectiveness of a collaborative system with AI and human role-sharing 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, Committee on Drug Evaluation
Data Science Subcommittee Task Force 1-2 for FY2024
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