Pub Date : 2021-11-16DOI: 10.1201/9781003109785-14
Hua Guo, Joshua Chen, H. Quan
{"title":"Local Treatment Effect Estimation by Borrowing Information from Similar Regions in Multi-Regional Clinical Trials","authors":"Hua Guo, Joshua Chen, H. Quan","doi":"10.1201/9781003109785-14","DOIUrl":"https://doi.org/10.1201/9781003109785-14","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121466903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-16DOI: 10.1201/9781003109785-15
W. Shih, Tai Xie, Kun He
{"title":"Global Drug Development: Multi-Regional Clinical Trials (MRCTs) – China's Pursuit","authors":"W. Shih, Tai Xie, Kun He","doi":"10.1201/9781003109785-15","DOIUrl":"https://doi.org/10.1201/9781003109785-15","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"177 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121041266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Implementation of the ICH E17 Guideline in Japan","authors":"Y. Aoi, Shuji Kamada, Yasuto Otsubo, Y. Uyama","doi":"10.1201/9781003109785-7","DOIUrl":"https://doi.org/10.1201/9781003109785-7","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124925054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B. Binkowitz, Gang Li, H. Quan, Gordon Lan, S. P. Ouyang, W. Robieson, William Wang, Sammy Yuan, Y. Tanaka, Josh Chen, Lanju Zhang, P. Gallo
{"title":"Lessons Learned from Actual Multi-Regional Clinical Trials with Signals of Treatment Effect Heterogeneity","authors":"B. Binkowitz, Gang Li, H. Quan, Gordon Lan, S. P. Ouyang, W. Robieson, William Wang, Sammy Yuan, Y. Tanaka, Josh Chen, Lanju Zhang, P. Gallo","doi":"10.1201/9781003109785-9","DOIUrl":"https://doi.org/10.1201/9781003109785-9","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125907483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-16DOI: 10.1201/9781003109785-11
Gang Li, H. Quan, Gordon Lan
{"title":"Analysis Models for Multi-regional Clinical Trials","authors":"Gang Li, H. Quan, Gordon Lan","doi":"10.1201/9781003109785-11","DOIUrl":"https://doi.org/10.1201/9781003109785-11","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124540903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"General Introduction of E17","authors":"Y. Uyama, Yasuto Otsubo, Shuji Kamada, Yoko Aoi","doi":"10.1201/9781003109785-1","DOIUrl":"https://doi.org/10.1201/9781003109785-1","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125667116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Consideration of “Ethnic Factors” in Design and Conduct of Multiregional Clinical Trials (MRCT)","authors":"Rominder Singh, Vibeke Bjerregaard","doi":"10.1201/9781003109785-3","DOIUrl":"https://doi.org/10.1201/9781003109785-3","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133581879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-16DOI: 10.1201/9781003109785-19
Jason J. Z. Liao, Yaru Shi, Ziji Yu
{"title":"Regional Sample Size Calculation in Multi-regional Equivalence and Non-inferiority Trials","authors":"Jason J. Z. Liao, Yaru Shi, Ziji Yu","doi":"10.1201/9781003109785-19","DOIUrl":"https://doi.org/10.1201/9781003109785-19","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129267059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xinman Zeng, Jun Wang, Zhaoyun Wang, Zhi-ming Yang, Min Li
{"title":"ICH E17 and MRCT: Implementation and Regulatory Perspective in China","authors":"Xinman Zeng, Jun Wang, Zhaoyun Wang, Zhi-ming Yang, Min Li","doi":"10.1201/9781003109785-8","DOIUrl":"https://doi.org/10.1201/9781003109785-8","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122634597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-16DOI: 10.1201/9781003109785-16
Lanju Zhang, W. Robieson
{"title":"Statistical Considerations in Design, Execution, and Analysis of Multiregional Clinical Trials: Consistency Evaluation and Adaptive Trials","authors":"Lanju Zhang, W. Robieson","doi":"10.1201/9781003109785-16","DOIUrl":"https://doi.org/10.1201/9781003109785-16","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"65 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122952180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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