2025 年 42 巻 3 号 p. 169-175
In recent years, the digital transformation (DX) of clinical research and clinical trials in Japan has played a crucial role in shaping the future of the medical field, marking a significant turning point. This paper explores the current state and forefront initiatives of clinical trial DX tailored to Japan's medical environment, focusing on the utilization of clinical trial support platforms, the introduction of artificial intelligence (AI), and the adoption of decentralized clinical trials (DCT).
First, the foundation of Japan's clinical trial DX lies in the implementation of clinical trial support platforms. A representative example is Buzzreach Inc.'s StudyWorks Platform, which leverages DX to provide innovative solutions addressing challenges in clinical trials. This platform facilitates seamless information sharing among stakeholders, enhances process efficiency, and improves transparency. By digitalizing communication among sponsors, trial sites, and participants, the platform enables centralized data management, contributing to the rapid execution and improved quality of clinical trials.
Next, this paper discusses Japan's strategic advantage of having the world's largest number of medical institutions and its application to patient recruitment. Japan's extensive network of medical institutions can significantly enhance recruitment efficiency. The use of partner (satellite) sites allows certain trial activities to be conducted at these facilities, increasing patient convenience and improving enrollment rates. This approach is closely linked to DCT implementation, allowing patients to participate in trials from home or nearby medical institutions, thereby reducing geographical and time constraints while ensuring diverse data collection.
Furthermore, AI integration plays a critical role in various trial processes. AI–driven data analysis of electronic health records (EHRs) and patient registries accelerates patient identification, improving the efficiency of patient enrollment. Additionally, AI is utilized for document generation and workflow optimization, enhancing the overall quality and outcomes of clinical trials.
Through this paper, we examine the current state and challenges of clinical trial digitization in Japan, explore potential solutions, and discuss how DX can be promoted within the country's unique environment. Finally, we identify the key elements essential for the success of clinical research and trial DX, aiming for more efficient and reliable clinical studies.
