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Simultaneous Global New Drug Development最新文献

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New Principles in Global Development Using ICH E 17 Guideline 使用ICH e17指南的全球发展新原则
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-2
Vibeke Bjerregaard, Rominder Singh
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引用次数: 0
Utilization of Robust Estimates of Treatment Effects via Semiparametric Models in MRCT 利用半参数模型对MRCT治疗效果进行稳健估计
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-12
M. Tan, Shilin Yu, Ao Yuan
{"title":"Utilization of Robust Estimates of Treatment Effects via Semiparametric Models in MRCT","authors":"M. Tan, Shilin Yu, Ao Yuan","doi":"10.1201/9781003109785-12","DOIUrl":"https://doi.org/10.1201/9781003109785-12","url":null,"abstract":"Multi-Regional Clinical Trial (MRCT) plays an increasingly important role in global drug development. It serves as an efficient way to accelerate drug development, allowing global simultaneous development and earlier access to new drugs, benefiting patients worldwide. MRCTs provide an opportunity for health authorities to examine robustness and the applicability of a treatment across diverse populations while assessing country specific benefit risk profile. I will highlight some key statistical issues recognized in ICH E17, e.g., increased heterogeneity in trials involving different regions. In addition, despite randomization, there may be a differential treatment effect among different regions, potentially due to confounding region specific factors. Thus, accurate and robust estimates of variation would be especially important to MRCT. Most current methods for the assessment of the consistency or similarity of the treatment effect between different ethnic groups are based on some subjectively specified model. In this talk I will summarize recent advances on robust estimates of global and regional treatment effects in MRCT though semiparametric modeling, and show the asymptotic and finite sample properties of the estimate and how they are applied to real clinical trials. (This work is in collaboration with Ao Yuan, Chaojie Yang, Shuxin Wang, and Shuqi Wang.)","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"67 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":"128045034","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}
引用次数: 0
Multi-regional Clinical Trials with Heterogeneous Regional Treatment Effects 不同区域治疗效果的多区域临床试验
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-18
Hsiao-Hui Tsou, Yu-Chieh Cheng, K. Lan, Hsiao-Yu Wu, Ya-Ting Hsu, Fang-Jing Lee, Chi-Tian Chen, Meng-Hsuan Wu, C. Hsiao
{"title":"Multi-regional Clinical Trials with Heterogeneous Regional Treatment Effects","authors":"Hsiao-Hui Tsou, Yu-Chieh Cheng, K. Lan, Hsiao-Yu Wu, Ya-Ting Hsu, Fang-Jing Lee, Chi-Tian Chen, Meng-Hsuan Wu, C. Hsiao","doi":"10.1201/9781003109785-18","DOIUrl":"https://doi.org/10.1201/9781003109785-18","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"33 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":"133597525","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}
引用次数: 0
Pooling Strategies 池策略
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-4
O. Komiyama, Shintaro Hiro, N. Matsuoka, Hideharu Yamamoto
{"title":"Pooling Strategies","authors":"O. Komiyama, Shintaro Hiro, N. Matsuoka, Hideharu Yamamoto","doi":"10.1201/9781003109785-4","DOIUrl":"https://doi.org/10.1201/9781003109785-4","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"23 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":"124816000","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}
引用次数: 2
Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology 利用国外临床数据外推加速全球药物开发:血液肿瘤学案例研究
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-10
Hongjie Zhu, Jingjing Ye, Xiang Guo
{"title":"Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology","authors":"Hongjie Zhu, Jingjing Ye, Xiang Guo","doi":"10.1201/9781003109785-10","DOIUrl":"https://doi.org/10.1201/9781003109785-10","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"23 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":"132767990","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}
引用次数: 0
Overall Sample Size and Allocation to Regions 总体样本量和区域分配
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-5
Aloka G Chakravarty, Xin Zeng, William Wang
{"title":"Overall Sample Size and Allocation to Regions","authors":"Aloka G Chakravarty, Xin Zeng, William Wang","doi":"10.1201/9781003109785-5","DOIUrl":"https://doi.org/10.1201/9781003109785-5","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"52 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":"133132889","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}
引用次数: 0
Hierarchical Linear Models for Multi-Regional Clinical Trials 多区域临床试验的层次线性模型
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-13
Seungheon Kang, Saemina Kim
{"title":"Hierarchical Linear Models for Multi-Regional Clinical Trials","authors":"Seungheon Kang, Saemina Kim","doi":"10.1201/9781003109785-13","DOIUrl":"https://doi.org/10.1201/9781003109785-13","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"91 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":"134460072","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}
引用次数: 0
Multiple Endpoints in Multiregional Clinical Trials 多区域临床试验中的多终点
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-17
T. Hamasaki, Yuh-Jenn Wu, C. Hsiao
{"title":"Multiple Endpoints in Multiregional Clinical Trials","authors":"T. Hamasaki, Yuh-Jenn Wu, C. Hsiao","doi":"10.1201/9781003109785-17","DOIUrl":"https://doi.org/10.1201/9781003109785-17","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"16 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":"128051300","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}
引用次数: 0
Consistency Evaluation in MRCTs 磁共振ct一致性评价
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-6
William Wang, Armin Koch, O. Komiyama
{"title":"Consistency Evaluation in MRCTs","authors":"William Wang, Armin Koch, O. Komiyama","doi":"10.1201/9781003109785-6","DOIUrl":"https://doi.org/10.1201/9781003109785-6","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"28 3 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":"126206248","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}
引用次数: 0
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