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
December 2025
JPMA’s DS Subcommittee conducted several AI prototyping projects in fiscal years 2022 and 2023 and has published the results.This report serves as a follow-up to those efforts. Since the publication of ICH E6 (R3) Step 4 was imminent at the start of the study, the focus was on “how AI can contribute to quality management in clinical trials,” and the following two prototyping projects were carried out.
- Support for Identifying Critical to Quality Factors
- Detection of Critical Issues Based on the Trial Protocol
These studies not only suggested the usefulness of AI in clinical trial quality management but also reaffirmed the importance of “Human-in-the-Loop” approaches. Furthermore, they demonstrated the effectiveness of a collaborative framework based on a division of roles between AI and humans.
This study is an example of a practical attempt to incorporate AI into clinical trial operations. Furthermore, this document records the process by which the authors proceeded through trial and error, allowing readers to retrace the steps taken and the line of reasoning that led to the final deliverables.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee,
, Data Science Subcommittee, FY2024 Task Force 1-2