PMDAでの経験とその後　アカデミアにおけるレギュラトリーサイエンスへ

抄録

Involvement of Neurologists in clinical research and trials is increasingly recognized, yet pharmaceutical affairs and regulatory science remain complex areas. This paper highlights the journey of a neurologist who transitioned around clinical research, pharmaceutical affairs, and regulatory science, focusing on experiences at the Pharmaceuticals and Medical Devices Agency (PMDA) and in academia. At PMDA, it is possible to experience review of new drugs and to deepen understanding of pharmaceuticals. The activities of regulatory science include initiatives for standardized clinical trial data and real–world data application, enhancing drug approval processes. In academia, neurologists with PMDA experience significantly contribute to drug development, supported by Academic Research Organizations (AROs). It is important to implement digital transformation in clinical trials including the shift to Electronic Data Capture (EDC) systems, CDISC data standards, innovative tools like ePRO, eCOA, and eConsent. Decentralized clinical trials (DCTs) and wearable devices are also transforming patient data collection and participation. The experience at PMDA is invaluable for the entire drug lifecycle, highlighting the need for collaboration between industry, government, and academia in regulatory science.