10016-CS-3 Establishment and Challenges of Clinical Research Support Systems at Non-Core Clinical Research Hospitals

Abstract Malignant brain tumors, including glioblastoma, remain highly intractable, and effective standard treatments have yet to be established for many tumor types. Thus, the development of novel therapeutic approaches remains an urgent need. As academic medical institutions, university hospitals are expected not only to provide general and advanced medical care but also to promote research and education. In particular, conducting high-quality clinical trials to generate scientific evidence for diseases with unmet medical needs, such as malignant brain tumors, is a vital mission. To facilitate clinical research and ensure proper implementation, many university hospitals have established Academic Research Organizations (AROs). Our Department has been involved in a number of clinical trials and studies since the establishment of the JCOG Brain Tumor Study Group in 2002. In recent years, with the enforcement of the Clinical Trials Act in Japan, we have conducted various non-commercial clinical studies, including specified clinical trials and advanced medical care, which require compliance with regulatory standards. However, at our institution, support systems for non-industry-sponsored clinical research beyond trial management and CRC support have been lacking. No dedicated Department existed to lead investigator-initiated, multi-center clinical trials as the sponsor institution, and support for site-level implementation was also insufficient. To fulfill our academic responsibilities, we launched a new Clinical Research Center this year to enhance ARO functions. Our goal is not to become a government-designated core clinical research hospital, but to establish a sustainable ARO system tailored to a private university hospital. Key challenges include securing qualified personnel such as regulatory specialists, obtaining operational funding, identifying physical space for the center, and developing standard operating procedures. In this presentation, we discuss the issues faced in building and managing an ARO in a non-core clinical research hospital and propose practical solutions based on our experience.