Drug Evaluation Committee June 13, 2025 "Patient Experience Information for Decision Making in Drug Development
Jun 18, 2025
The material of "What is Useful Patient Experience Information for Decision-Making in Drug Development?
ICH will issue a Reflection Paper on "Patient Focused Drug Development" in 2021, advocating the use of information from patients (patient experience information) for drug evaluation. It is expected that patient experience information will be incorporated into the benefit-risk assessment of drugs and used for decision-making by regulatory authorities in the drug approval review process. Relatedly, ICH E22 "General Considerations for Patient Preference Studies" is expected to complete Step 1 by the end of 2025. In light of these circumstances, the Data Science Subcommittee published the report "Utilization of Patient Experience Information for Patient-Focused Drug Development - For Decision Making Based on Patients' Voices" in April 2025. Based on the report, this session will introduce trends in the use of patient experience information in various organizations and present examples of patient preference and patient preference research for clinical outcome evaluation, including PROs, and decision making based on patient perspectives. We hope this presentation will help you understand the use of patient experience information.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
DS Subcommittee 2025 Task Force 6
Report Deliverables
Utilization of Patient Experience Information for Patient-Focused Drug Development - For Decision-Making Based on Patients' Voices
https://www.jpma.or.jp/information/evaluation/results/allotment/DS_202504_PFDD.html
Briefing Materials
What is useful patient experience information for decision making in drug development?
Video Recording of the Briefing Session
The recording of this briefing can be viewed at the following link
YouTube link: https://youtube.com/live/lTKzS26xU7Q?feature=share