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检索条件"机构=Biostat and Programming"
416 条 记 录,以下是81-90 订阅
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Rejoinder to "on the alternative hypotheses for the win ratio"
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BIOMETRICS 2019年 第1期75卷 352-354页
作者: Luo, Xiaodong Tian, Hong Mohanty, Surya Tsai, Wei Yann Sanofi US Dept Biostat & Programming Res & Dev Bridgewater NJ 08807 USA Janssen Res & Dev Raritan NJ 08869 USA Columbia Univ Dept Biostat New York NY 10032 USA
The article discusses about the potential use of the win ratio, focusing on the null hypothesis, expanding of the corresponding alternative hypothesis and the testing of null hypothesis against alternative hypothesis....
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Unified Inference for Sparse and Dense Longitudinal Data in Time-varying Coefficient Models
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SCANDINAVIAN JOURNAL OF STATISTICS 2017年 第1期44卷 268-284页
作者: Chen, Yixin Yao, Weixin Sanofi Genzyme Dept Biostat & Programming Cambridge MA USA Univ Calif Riverside Dept Stat Riverside CA 92521 USA
Time-varying coefficient models are widely used in longitudinal data analysis. These models allow the effects of predictors on response to vary over time. In this article, we consider a mixed-effects time-varying coef... 详细信息
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Design and monitoring of survival trials in complex scenarios
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STATISTICS IN MEDICINE 2019年 第2期38卷 192-209页
作者: Luo, Xiaodong Mao, Xuezhou Chen, Xun Qiu, Junshan Bai, Steven Quan, Hui Sanofi US Dept Biostat & Programming Res & Dev Bridgewater NJ 08807 USA FDA CDER Off Translat Sci Off BiostatDB1 Silver Spring MD USA
This paper proposes an approach to design and monitor survival trials accounting for complex scenarios such as delayed treatment effect, treatment dilution, and treatment crossover. These scenarios often lead to non-p... 详细信息
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Evaluation of local treatment effect by borrowing information from similar countries in multi-regional clinical trials
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STATISTICS IN MEDICINE 2016年 第5期35卷 671-684页
作者: Guo, Hua Chen, Joshua Quan, Hui Allergan Pharmaceut Inc Dept Stat Sci Jersey City NJ 07311 USA Sanofi Pasteur Biostat Swiftwater PA 18370 USA Sanofi Biostat & Programming Bridgewater NJ 08807 USA
One key objective of a multi-regional clinical trial (MRCT) is to quantify country-specific treatment effects to support local registration. Naive estimate of the treatment effects based on country-specific subsets of... 详细信息
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Analysis of a binary composite endpoint with missing data in components
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STATISTICS IN MEDICINE 2007年 第26期26卷 4703-4718页
作者: Quan, Hui Zhang, Daowen Zhang, Ji Devlamynck, Laure Sanofi Aventis Biostat & Programming Bridgewater NJ 08807 USA N Carolina State Univ Dept Stat Raleigh NC 27695 USA
Composite endpoints are often used in clinical trials in order to increase the overall event rates, reduce the sizes of the trials and achieve desired power. For example, in a trial to study the effect of a treatment ... 详细信息
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DESIGN AND SAMPLE SIZE CONSIDERATIONS FOR SIMULTANEOUS GLOBAL DRUG DEVELOPMENT PROGRAM
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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2012年 第5期22卷 1060-1073页
作者: Huang, Qin Chen, Gang Yuan, Zhilong Lan, K. K. Gordon SFDA Ctr Drug Evaluat Off Biostat Beijing 100038 Peoples R China Johnson & Johnson Biostat & Programming Raritan NJ USA Johnson & Johnson Quantitat Decis Strategies Raritan NJ USA
Due to the potential impact of ethnic factors on clinical outcomes, the global registration of a new treatment is challenging. China and Japan often require local trials in addition to a multiregional clinical trial (... 详细信息
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Considerations on Testing Secondary Endpoints in Group Sequential Design
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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2017年 第4期9卷 333-337页
作者: Li, Xiaoming Wulfsohn, Michael S. Koch, Gary G. Atara Biotherapeut Biostat & Programming Westlake Village CA 91361 USA Gilead Sci Inc Biostat 353 Lakeside Dr Foster City CA 94404 USA Univ N Carolina Biostat Chapel Hill NC USA
In the fixed sample size design, when the null hypothesis for the primary endpoint is rejected at trial completion, secondary endpoints sometimes are tested at the full alpha level in a prespecified hierarchical order... 详细信息
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Evaluation of alternative confidence intervals to address non-inferioritythrough the stratified difference between proportions
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PHARMACEUTICAL STATISTICS 2021年 第1期20卷 146-162页
作者: Sui, Jiatong Jiao, Jenny Sun, Yijun Liu, Jeen Bastero, Rowena Koch, Gary Univ Rochester Biostat Rochester NY 14627 USA Allergan Plc Stat Sci & Programming Dublin Ireland Astex Pharmaceut Inc Biostat Pleasanton CA USA Univ N Carolina Dept Biostat Chapel Hill NC 27515 USA
The confidence interval (CI) for the difference between two proportions has been an important and active research topic, especially in the context of non-inferiority hypothesis testing. Issues concerning the Type 1 er... 详细信息
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Approximating power of the unconditional test for correlated binary pairs
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COMMUNICATIONS IN STATISTICS-SIMULATION AND COMPUTATION 1998年 第2期27卷 553-564页
作者: Selicato, GR Muller, KE Stat Programming Syst Quintiles Inc Res Triangle Pk NC 27709 USA Univ N Carolina Dept Biostat Chapel Hill NC 27599 USA
We provide a simple and good approximation of power of the unconditional test for two correlated binary variables. Suissa and Shuster (1991) described the exact unconditional test. The most commonly used statistical t... 详细信息
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Dynamic Monitoring of Ongoing Clinical Trials
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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2022年 第4期14卷 580-591页
作者: Xie, Tai Zhang, Peng Shih, Weichung Joe Tu, Yue Lan, K. K. Gordon Brightech Int Dept Biostat & Programming 285 Davidson Ave Somerset NJ 08873 USA State Univ New Jersey Rutgers Univ Sch Publ Hlth Dept Biostat & Epidemiol Piscataway NJ USA
In late 2019, the U.S. FDA updated a new Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. The guideline encourages developing and implementing innovative trial designs for future c... 详细信息
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