Japan: An Opportunity to Learn?

Yuji Sato

研究成果: Chapter

抜粋

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.

元の言語English
ホスト出版物のタイトルRe-Engineering Clinical Trials
ホスト出版物のサブタイトルBest Practices for Streamlining the Development Process
出版者Elsevier Inc.
ページ23-30
ページ数8
ISBN(電子版)9780128007907
ISBN(印刷物)9780124202467
DOI
出版物ステータスPublished - 2015 1 1

ASJC Scopus subject areas

  • Nursing(all)

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  • これを引用

    Sato, Y. (2015). Japan: An Opportunity to Learn?Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process (pp. 23-30). Elsevier Inc.. https://doi.org/10.1016/B978-0-12-420246-7.00003-7