Activities of the Global Clinical Research Support Office
The Department of Medical Innovation(dmi), Osaka University Hospital, was appointed in September 2016 for the Global Clinical Trial Development Project led by the Japan Agency for Medical Research and Development (AMED). In response to this appointment, the Global Clinical Research Support Office (GCRSO) was launched within the dmi. The office is engaged in the following activities:
- 1. Structural organization to support global multi-regional clinical research
- The dmi has contributed to the establishment of foundations including a cell processing facility, a PET microdose trial facility, a GMP-compliant investigational drug manufacturing facility, and a phase 1 clinical trial facility through activities such as translational research promotion activities and developing a base for early-stage exploratory clinical trials. Moreover, the Center for Global Health within the hospital proactively receives foreign patients and trainees while at the same time serving as a starting point for the development of Japan-made medical care outside Japan. The center has also been engaged in organizing university–industry collaborative cross-innovation initiatives and global health initiatives, for which the center has engaged in activities to facilitate partnership-making with corporate entities and licensing at the same time as promoting investigator-initiated clinical research.
- The newly established GCRSO respects cross-sectional alliances with existing facilities and organizations and will act as the core base for global multi-regional clinical research by structuring a system that will serve to support and promote clinical research that meets international standards.
- 2. Support for multi-regional clinical research and trials
- As of August 2016, the dmi was engaged in more than 100 research projects within and outside the university. Among them are research projects focused on international development. For these research projects, Global Project Managers are assigned and will be engaged in planning and designing global clinical research projects and providing a wide range of support and promotion, including the provision of foreign regulatory information and research grant information and support related to ethical review committees. Moreover, the GCRSO will proactively support new global projects and global clinical research within and outside the university.
- 3. Education and training / human resource development
- Several times a year, the GCRSO provides public education and training seminars for not only researchers, but also research supporters and students. In addition, the office will periodically host an international symposium and communication workshops in collaboration with the “National Cancer Center Hospital,” a core hospital and another base for the Global Clinical Trial Development Project . Through these projects, the office will provide attendees with an opportunity to acquire knowledge indispensable for conducting multi-regional clinical research and to learn the differences between international and domestic clinical research in order to meet challenges that need to be met in the context of conducting international clinical research in the hopes of strengthening the system. The GCRSO proactively offers on-the-job training (OJT) in which researchers and supporters of research projects at relevant facilities are directly involved in research projects so as to broaden the base of know-how for organizing global multi-regional clinical research and trials.
Through these three pillars of activity, the GCRSO will continue to contribute to the acceleration of the commercialization of pharmaceuticals, medical devices, and regenerative medicine products by academia while fully respecting regulatory differences inside and outside Japan.