Drug Evaluation Committee Quality Control in Drug Development -Examination of Risk Communication
December 2023
The Data Science Subcommittee of the Drug Evaluation Committee’s FY2022 Continuing Task Force 5-2 focused on risk communication, examining the current issues and points of consideration regarding pharmaceutical companies, health authorities, physicians, allied health professionals,clinical research coordinators (CRCs), and patients—specifically regarding informed consent forms, package inserts, risk management plans, and patient guides—and compiled recommendations. Regarding informed consent forms, as they serve as a critical communication tool between companies and clinical trial participants, the group devoted significant attention to discussing them when considering issues related to risk communication.
We hope that this report will contribute to improving communication among stakeholders, including patients, and further accelerate drug development and the appropriate use of pharmaceuticals.
Japan Pharmaceutical Manufacturers Association (JPMA)
Drug Evaluation Committee, Data Science Subcommittee
FY2021 Task Force 5-2 / FY2022 Continuing Task Force 5-2
Hironori Sakai (Eisai), Yasushi Komiyama (Pfizer), Hiroshi Komori (Eisai), Masanori Ueda (Chugai Pharmaceutical)
- Report (Quality Control in Drug Development: A Study on the Approach to Risk Communication) (1,596 KB)
- Appendix: Opinions on the ICF and Communication Gathered from Patient Organizations (323 KB)
- Appendix: Opinions on the ICF and Communication Gathered from Former Clinical Research Coordinators (CRCs) (402 KB)