Drug Evaluation Committee Systematic Survey on RWD/RWE - FDA Approval Cases and Approaches to Challenges Using Innovative Technologies
Clinical Evaluation Subcommittee
While the use of Real World Data (RWD) and the creation of Real World Evidence (RWE) are becoming increasingly important in the pharmaceutical industry, there are still challenges specific to RWD/E.
The FY2024/2025 Clinical Evaluation Subcommittee and Continuing Issues Response Team 9 will conduct a systematic survey of Noting the lack of systematic research on FDA-approved cases and the application of innovative new technologies that could overcome the RWD/E limitation, the FY2024/2025 Clinical Evaluation Subcommittee and Ongoing Issues Team9 will conduct research on recent FDA-approved cases and new technologies (Tokenization, Digital twin, LLM/NLP + Target Trial Emulation) of note. Target Trial Emulation).
Through the publication of this report, we hope to contribute to the early realization of an environment in which RWE is widely used in drug development by providing readers with hints for learning from precedents and identifying opportunities for RWD/E utilization.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Clinical Evaluation Subcommittee Continuing Issues Response Team 9