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W-14: IRB Submissions and Approvals in Japan: A review





Poster Presenter

      Nozomu Miyawaki

      • Senior Manager
      • SOUSEIKAI Global Clinical Research Center
        Japan

Objectives

Japanese IRBs seem not to be very well understood abroad. The conservative image of Japanese culture and the knowledge gap regarding Japanese GCPs are thought to have contributed to this misunderstood image. This research reviewed the past 29 years of our Central IRB issues and solutions.

Method

We reviewed the minutes of IRB meetings held at SOUSEIKAI Hakata Clinic in Japan from 1988 to 2016, and studied the discussions of all studies submitted. We also selected studies that had issues after first submission, and investigated the details behind their eventual approvals.

Results

SOUSEIKAI’s Central IRB at Hakata Clinic, composed of 13 members and located in Fukuoka, Japan, reviewed over 3,300 research applications over the past 29 years. Among those applications, over 1,000 protocols were Phase 1 studies that included 800+ new chemical entities. Almost all research protocols were approved after their initial submission. The most discussed issues were examples of ethical concerns, AEs from preclinical studies or from the studies conducted abroad, lack of information, First In Human studies, biologics/biosimilars, female studies, adaptive/ flexible study designs, invasive protocol studies, and onocology studies with healthy volunteers.

Conclusion

As the trends of clinical trials are changing, the requirements for IRBs also are both increasing in number and becoming more and more diverse. As an IRB, concrete experience and knowledge from various academic and social fields are also essential, as well as the assurance of subject safety and privacy. From these aspects, and in terms of quality and speed of review, Japanese IRBs are similar to IRBs abroad. Although when submitting studies to IRBs in Japan the requirements involve the translation of protocol summaries into the Japanese language, cultural differences often lead to a substantial discussion about each study very thoroughly and contribute to the conducting of safe clinical trials in Japan, in addition to further solidifying the IRB foundation. In the presentation of this research we will demonstrate and discuss studies with complicated issues from various aspects using some of our case studies.