抄録
From the perspective of simultaneous drug development, Japan has been rapidly losing its competitiveness in terms of efficiency and cost-effectiveness compared to Western and other Asian countries. There is a need to improve the clinical trial environment in Japan, in line with international standards, in order to bring quality medicines to patients more quickly.
The EFPIA conducted this survey to determine the current organisation of clinical trials at medical institutions in Japan through the following assessments. 1) procedures for trial application, 2) IRB, 3) support by CRC, 4) management of essential documents, 5) SDV, and 6) handling of safety information. Further, these results were compared with a similar study conducted in March 2003. The results confirmed that improvements have been observed in some aspects, such as markedly improved support by CRC, however many issues remain unsolved, such as the requirements of SDV and how safety information is handled.
Based on these results, we present proposals for improving the clinical trial environment in Japan to improve competitiveness internationally, focusing on speed and the reduction of cost of clinical trials.
