Japan: An Opportunity to Learn?

Japan has not been widely regarded as an ideal country for multinational trials, with drawbacks including local regulations and practices, language differences and high trial costs. However, the last 10 years have seen improvements in the clinical research infrastructure under the governmental initiatives, together with efforts by both the pharmaceutical industry and investigational sites. Therefore, apart from the remaining issue of trial costs, the other obstacles have been largely overcome. Furthermore, the operational excellence common to Japanese manufacturing industry at large is equally to be found in clinical trial operations, which leads to high-quality trial results and outstanding operational metrics. This chapter summarizes evidence of operational excellence in Japan, with some suggestions as to how the challenges facing us all in global trial operations might be tackled.