[Operational aspect of participation in the multi-national clinical trials from the foreign pharmaceutical company's standpoint].

As a means to reduce the delay with the West, the enhanced use of multi-national clinical trials is expected. It is necessary to improve the presence of Japan as a development base by making the best use of the quality of the clinical trials and becoming more competitive in terms of the speed and the cost as compared with other Asian countries. The development team in Japan has to play an active role in the planning stage of the trial and support improvements in the IT environment of the medical institution for introducing clinical trial management systems such as EDC. I expect the medical institutions to simplify the procedures required for conducting clinical trials, to accept English documents, to secure doctor's time for the clinical trials and to increase the number of CRCs, etc. The elimination of the difference between the domestic and international regulations is expected of the regulator. Finally, the revision of medical institutions by the government would contribute improvements in the current situation where staff are too busy to conduct clinical trials.