Drug Evaluation Committee
Utilization of Patient Experience Information for Patient-Focused Drug Development
Utilization of Patient Experience Information for Patient-Focused Drug Development -For Decision-Making Based on the Voice of the Patient
Data Science Subcommittee
April 2025
ICH will issue a Reflection Paper on Patient Focused Drug Development in 2021, advocating the use of patient experience data for drug evaluation. However, there are no guidelines in Japan that provide an overview of how patient experience data should be handled, what kind of data should be collected, and how it should be used. Therefore, the Task Force has prepared a report that describes patient experience data, such as patient preference information and patient-reported outcomes, and summarizes recent proposals by regulatory authorities and the current status of their use. The intended audience for this report is statisticians, clinical officers, and other personnel involved in clinical development who are considering and discussing the use of patient experience data from a data science perspective. We hope that this report will help you to consider how patient experience data can be applied to drug development in Japan.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee 2024 Task Force 6
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