{"title":"日本和美国抗癌药物首次人体试验及获批概率的横断面研究。","authors":"Akari Mukaida, Hideki Maeda","doi":"10.1007/s10147-025-02849-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This study aimed to examine the characteristics of First-in-human (FIH) trials conducted in Japan and the US and whether the probability of approval for pharmaceuticals that had undergone FIH trials differs in the two countries.</p><p><strong>Methods: </strong>FIH trials of anticancer drugs initiated between 2007 and 2017 were investigated in this study. The trials were searched using ClinicalTrials.gov.</p><p><strong>Results: </strong>There were 22 FIH trials conducted in Japan and 261 in the US. Of these, six drugs (27.2%) were approved in Japan and 27 (10.3%) were approved in the US, indicating that the probability of approval was significantly higher for FIH trials conducted in Japan than in the US. Comparison of the characteristics of FIH trials between Japan and the US, showed that 81.8% of the FIH trials conducted in Japan were sponsored by the top 20 pharmaceutical companies, whereas 55.6% in the US were sponsored by non-top 20 companies (P = 0.003, Chi-square test). The number of patients was higher in Japan than in the US (P = 0.044). Further, all of the trials conducted in Japan were multiregional clinical trials in collaboration with other countries such as Europe and the US, whereas 49.0% of the trials in the US were conducted in the US alone (P < 0.001).</p><p><strong>Conclusion: </strong>We inferred that the FIH trials conducted in Japan are multiregional clinical trials by major pharmaceutical companies with Europe and the US, and are conducted with drugs that are expected to have a high probability of successful approval.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1946-1952"},"PeriodicalIF":2.8000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474682/pdf/","citationCount":"0","resultStr":"{\"title\":\"A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval.\",\"authors\":\"Akari Mukaida, Hideki Maeda\",\"doi\":\"10.1007/s10147-025-02849-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This study aimed to examine the characteristics of First-in-human (FIH) trials conducted in Japan and the US and whether the probability of approval for pharmaceuticals that had undergone FIH trials differs in the two countries.</p><p><strong>Methods: </strong>FIH trials of anticancer drugs initiated between 2007 and 2017 were investigated in this study. The trials were searched using ClinicalTrials.gov.</p><p><strong>Results: </strong>There were 22 FIH trials conducted in Japan and 261 in the US. Of these, six drugs (27.2%) were approved in Japan and 27 (10.3%) were approved in the US, indicating that the probability of approval was significantly higher for FIH trials conducted in Japan than in the US. Comparison of the characteristics of FIH trials between Japan and the US, showed that 81.8% of the FIH trials conducted in Japan were sponsored by the top 20 pharmaceutical companies, whereas 55.6% in the US were sponsored by non-top 20 companies (P = 0.003, Chi-square test). The number of patients was higher in Japan than in the US (P = 0.044). Further, all of the trials conducted in Japan were multiregional clinical trials in collaboration with other countries such as Europe and the US, whereas 49.0% of the trials in the US were conducted in the US alone (P < 0.001).</p><p><strong>Conclusion: </strong>We inferred that the FIH trials conducted in Japan are multiregional clinical trials by major pharmaceutical companies with Europe and the US, and are conducted with drugs that are expected to have a high probability of successful approval.</p>\",\"PeriodicalId\":13869,\"journal\":{\"name\":\"International Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"1946-1952\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474682/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10147-025-02849-4\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/8/6 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10147-025-02849-4","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/6 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval.
Background: This study aimed to examine the characteristics of First-in-human (FIH) trials conducted in Japan and the US and whether the probability of approval for pharmaceuticals that had undergone FIH trials differs in the two countries.
Methods: FIH trials of anticancer drugs initiated between 2007 and 2017 were investigated in this study. The trials were searched using ClinicalTrials.gov.
Results: There were 22 FIH trials conducted in Japan and 261 in the US. Of these, six drugs (27.2%) were approved in Japan and 27 (10.3%) were approved in the US, indicating that the probability of approval was significantly higher for FIH trials conducted in Japan than in the US. Comparison of the characteristics of FIH trials between Japan and the US, showed that 81.8% of the FIH trials conducted in Japan were sponsored by the top 20 pharmaceutical companies, whereas 55.6% in the US were sponsored by non-top 20 companies (P = 0.003, Chi-square test). The number of patients was higher in Japan than in the US (P = 0.044). Further, all of the trials conducted in Japan were multiregional clinical trials in collaboration with other countries such as Europe and the US, whereas 49.0% of the trials in the US were conducted in the US alone (P < 0.001).
Conclusion: We inferred that the FIH trials conducted in Japan are multiregional clinical trials by major pharmaceutical companies with Europe and the US, and are conducted with drugs that are expected to have a high probability of successful approval.
期刊介绍：
The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.
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