How can we contribute to innovative drug development? ~From our experience in participating global study

[Speaker] Yuko Kageyama:1
[Co-author] Kazuko Miyamoto:1, Michitaka Yanagida:1, Chie Sakanaka:1
1:Clinical Research Support Center, Phase1 Unit, The University of Tokyo Hospital, Japan

 Although "drug lag" in Japan has been greatly reduced in recent years particularly in regulatory approval times, it is still required to speeding up the process of clinical drug development under the competitive and globalized environment. As one of the solutions for the problem, it has been encouraged to participate global clinical trials (GCTs) from early phase of clinical development.
 Phase 1 (P1) Unit at the University of Tokyo was established in May 2012, partly funded by the government under the Program for consolidating a center for early-stage exploratory clinical trials (FY2011-2015) as a dedicated clinical trial facility. P1 unit is aiming to build a system which is capable of conducting first-in human clinical study.
 Based on our experiences and research, we found a number of differences in clinical trial operation between Japan and other countries, such as Institutional Review Board(IRB), volunteer recruitment, etc. For example, utilization of "central IRB" is not uncommon in some countries, but it is not yet fully established in Japan. We also noticed the differences in subject recruitment. In the United States, healthy volunteers are recruited by the Contract research organization (CRO) which sometimes operates its own clinical research site, whereas it is commonly done by the clinical research site or by specialized volunteer recruitment company in Japan. In addition, some patient recruitment service providers are available in other countries.
 We believe that participating GCTs in early phase is inevitable in promoting innovative drug development in Japan. From our experience in participating early phase GCT as well as late phase GCT, we gain some insights in preparing for GCTs in the future.

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