臨床研究のDXに対するARO（Academic Research Organization）の取り組み

抄録

Clinical research conducted in academia faces various challenges, such as limited research funding, time constraints, manpower shortages, and insufficient knowledge with increasingly complex regulations. To overcome these challenges, Academic Research Organizations (AROs) provide support to researchers affiliated with universities and research institutions. Recently, digital transformation (DX) has been advancing in clinical research, with the use of digital tools expanding in areas such as informed consent, clinical evaluation, and data collection. AROs are working on building operational frameworks and systems to introduce DX–driven clinical research methods and decentralized clinical trials (DCT). It is the important mission of ARO to lead research to success while maximizing the benefits of DX and DCT within limited resources. This paper introduces the ARO's initiatives in these areas.