< Relevant articles > PubMed Aoi, Y., Kato, Y., Asano, K., Otsubo, Y. & Uyama, Y. Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan. Ther Innov Reg Sci 57, 1298-303 (2023). 10.1007/s43441-023-00566-6 < Background > In the era of global drug development, the cases of new drug application including multi-regional clinical trials (MRCTs) have increased in Japan. For further collaboration in Asia, it is useful to examine the enrollment status of Asian participants in MRCTs evaluated for drug approval in Japan in order to further promote proper development. < Outline> In this study, characteristics of MRCTs reviewed for drug approval in Japan were investigated to explore opportunities for collaborations on global drug development in Asia. As a result, more than 90% of reviewed trials were conducted as global MRCTs. In addition to Japan, Asian countries, US, and Europe have participated in various types of MRCTs. When investigating Asian participants as East Asia and South-East Asia separately, approximately 70% of MRCTs with Japan participation also include the participants in East-Asian countries. On the other hand, the MRCTs participated by South-East Asia accounted for less than 30%. When the percentage of patients in MRCTs was examined, the presence of participation in East-Asia or South-East Asia did not affect the proportion of Japanese patients in MRCTs. However, when these East-Asian or South-East Asian countries joined MRCTs simultaneously with Japan, the proportion of Asian patients approximately 32% with participation of both East and South-East Asia. These results suggest that further collaboration in lead to a sound scientific basis in considering the proper application of the pooled concept described in the ICH E17 guideline. < Impact on RS, expectations > This study suggests that strengthening collaboration between Japan and Asian countries will enable appropriate promotion of drug development and evaluation of efficacy and safety, etc. in consideration of ethnic factors, and may be useful in considering future international collaboration and international harmonization of regulations in Asia. Associate Executive Director (Research Division), Yoshiaki Uyama 17 was approximately 12% for Japan alone while it was increased to approximately 19% with participation of East-Asia and to MRCTs between Japan and other Asian countries, especially South-East Asia, may yield more data of Asian populations and Between South-East Asia, East Asia, and Japan Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration
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