Drug Evaluation Committee Evolution and Deepening of Data Management in Drug Development - Recommendations for Organizations and Human Resources 2025-.
Data Science Subcommittee
November 2025
The environment surrounding drug development is undergoing a period of unprecedented change, including distributed clinical trials (DCT), which are attracting attention as a patient-centered approach, the use of real world data (RWD), the evolution of AI and digital technologies, and GCP Renovation. In the midst of this transformation, data managers are required to evolve beyond mere data collection and management to become involved from the trial design stage and contribute to the success of clinical trials through data strategy development and quality control. The key to optimizing the quality and increasing the efficiency of clinical trials lies in the strategic use of data managers. We hope that the recommendations in this report on the new role of the data manager in response to the increasingly diverse and complex clinical trials, the optimization of the organizational structure to realize this role, and the importance of human resource development will encourage upper management responsible for organizational development to consider organizational reform and change, and lead to concrete actions at their companies. We hope that our recommendations on the importance of human resource development and the optimization of organizational structures for the realization of organizational change will encourage the top management responsible for building organizations to consider organizational reform and change and lead to concrete action at their companies.
For those who would like to grasp the overall picture of this report first, please read the executive summary that was prepared together with this document.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
FY2024 Data Science Subcommittee TF1-1
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