{"title":"Japan's Perspective on Facilitating Drug Development Through Asian Cooperation in Multi-Regional Clinical Trials: Insights From Regulatory Research","authors":"Masahiro Tohkin, Yoshiro Saito, Yoshiaki Uyama","doi":"10.1111/cts.70347","DOIUrl":null,"url":null,"abstract":"<p>Multi-regional clinical trials (MRCTs) have recently become a popular strategy for novel drug development, contributing to the early access to novel medicines in participating regions by enhancing development efficiency. To further facilitate MRCTs in Asia, the Japanese government has financially supported research activities in Japan for over 15 years that have studied the effect of ethnic factors on drug responses and identified practical challenges in conducting MRCTs in Asia. This mini-review highlights these research outcomes and related articles and presents our perspective on the current situation and future direction of MRCTs to explore opportunities for more collaboration between Japan and other East Asian/South-East Asian countries to facilitate drug development.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 9","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70347","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cts-Clinical and Translational Science","FirstCategoryId":"3","ListUrlMain":"https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.70347","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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Abstract
Multi-regional clinical trials (MRCTs) have recently become a popular strategy for novel drug development, contributing to the early access to novel medicines in participating regions by enhancing development efficiency. To further facilitate MRCTs in Asia, the Japanese government has financially supported research activities in Japan for over 15 years that have studied the effect of ethnic factors on drug responses and identified practical challenges in conducting MRCTs in Asia. This mini-review highlights these research outcomes and related articles and presents our perspective on the current situation and future direction of MRCTs to explore opportunities for more collaboration between Japan and other East Asian/South-East Asian countries to facilitate drug development.
期刊介绍：
Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
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