15th DIA Japan Annual Meeting 2018

Technological innovation surrounding clinical trials such as introduction of IoT, AI, secondary use of clinical data, applying simulation etc. is progressing at an unprecedented speed. There is also a growing need for clinical trials in a new framework, such as precision medicine or development of regenerative medicinal products and/or gene therapy. On the other hand, the development cost and productivity improvement challenges are still large, and Japan specific regulations could be a hurdle to implement innovative way. Under such an environment, the real value of Japan in global development is being sought after. In this session, following the overview of the whole session, the current state of remote trial model and new evidence building by secondary data use will be shared. With such background information, the direction Japan should go and what is necessary will be discussed.