As of September 2016, the Department of Medical Innovation(dmi), Osaka University Hospital, was appointed as a member of a Global Clinical Trial Development Project led by the Japan Agency for Medical Research and Development. In response to the appointment, we established the Global Clinical Research Support group within the hospital. I was appointed to serve as head of the office and I would like to make some comments in this greeting message.
The globalization of research and development has brought increasing changes in various fields, including medicine. In such a context, global clinical research can offer such benefits as reduced time spent on the development of novel drugs and medical devices, regenerative medicine, and identifying differences in ethical concerns. At the same time, such globalization brings various challenges, such as tackling differences in regulations on conducting and approving studies, the composition of ethical review committees/review approaches, the international transport of pharmaceutical compounds and specimens, medical insurance systems, international research fund transfers, and languages.
We believe that we need to identify and overcome these challenges through our own initiatives and accumulate related know-how, which will eventually contribute to the promotion of clinical research that meets international standards. Through these activities, we would ultimately like to contribute to bringing forward the initiation of global clinical research projects for pharmaceuticals, medical devices, and regenerative medicine products which have been developed by academia, with the supervision from the hospital director and chair of the dmi. We would appreciate your ongoing advice and guidance.
Head of Global Clinical Research Support Group
Department of Medical Innovation, Osaka University Hospital Daisaku NAKATANI