Development of CRC Training Program to Improve the International Competitiveness in Drug Development

2015 Fiscal Year Final Research Report

• Project/Area Number: 26670272
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Applied pharmacology
• Research Institution: Keio University
• Principal Investigator: Matsushima Yukiko 慶應義塾大学, 医学部, 特任講師 (10618531)
• Co-Investigator(Kenkyū-buntansha): Hisashi Urushihara 慶應義塾大学, 薬学部, 准教授 (10511917)
• Research Collaborator: Daisuke Utsui 慶應義塾大学, 薬学部 ; Akiko Yoshitani 慶應義塾大学, 医学部, 研究員 ; Aki Iguchi 慶應義塾大学, 医学部, 特任助教 ; Kyoko Matsuda 国立病院機構大阪南医療センター, 薬剤部・治験管理室, CRC ; Mayumi Watanabe 日本大学医学部附属板橋病院, 臨床研究推進センター, CRC ; Junko Yamasaki 神戸大学医学部附属病院, 臨床研究推進センター, CRC ; Brosnan Katrina Queensland Department of Health, Principal Policy Officer ; Hall Cindy Princess Alexandra hospital, Cardiology department ; Lee Steph Princess Alexandra hospital, Cancer Trial unit
• Project Period (FY): 2014-04-01 – 2016-03-31
• Keywords: CRC / 人材育成 / 国際共同治験 / 医薬品臨床開発 / 医療

Outline of Final Research Achievements

In this study, we performed comparative analysis on the operations and the education contents of Clinical Research Coordinator (CRC) in Japan and Australia where global clinical trials are frequently performed. We clarified the operations that are additionally needed for the CRC duties in Japan and evaluated an appropriate education content to train such necessary options aiming to improve the global competitiveness of Japan in the drug development area. We elucidated that the operation additionally needed is ‘Total Clinical trial management at Site’ and the education contents for this should include the training programs for ‘Formulating Research Question’ and ‘Development of clinical trials reports, results and publications’ and ‘Budget building and financial management’.

Free Research Field

臨床試験管理