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检索条件"机构=Biostat and Programming"
418 条 记 录,以下是1-10 订阅
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Utilization of treatment effect on a surrogate endpoint for planning a study to evaluate treatment effect on a final endpoint
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PHARMACEUTICAL STATISTICS 2023年 第4期22卷 633-649页
作者: Quan, Hui Xu, Zhixing Luo, Junxiang Paux, Gautier Cho, Meehyung Chen, Xun Sanofi Biostat & Programming Bridgewater NJ USA Moderna Biostat & Programming Cambridge MA USA Sanofi Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA
To design a phase III study with a final endpoint and calculate the required sample size for the desired probability of success, we need a good estimate of the treatment effect on the endpoint. It is prudent to fully ... 详细信息
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Generalizing Treatment Effect to a Target Population Without Individual Patient Data in a Real-World Setting
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PHARMACEUTICAL STATISTICS 2025年 第1期24卷 e2435页
作者: Quan, Hui Li, Tong Chen, Xun Li, Gang Sanofi Biostat & Programming Bridgewater NJ 08807 USA Eisai Inc Nutley NJ USA
The innovative use of real-world data (RWD) can answer questions that cannot be addressed using data from randomized clinical trials (RCTs). While the sponsors of RCTs have a central database containing all individual... 详细信息
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Comparison of two methods for seamless phase II/III Clinical trials using early outcome for treatment selection
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COMMUNICATIONS IN STATISTICS-SIMULATION AND COMPUTATION 2024年
作者: Hsu, Ken-Ning Shih, Weichung Joe WuXi Clin Dept Biostat & Stat Programming Taipei Taiwan Rutgers State Univ Sch Publ Hlth Dept Biostat & Epidemiol Piscataway NJ USA
Seamless phase II/III trials have been advocated following the US Food and Drug Administration's Critical Path Initiative lunched in 2004. Statistical methods have been proposed to address the treatment selection ... 详细信息
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A generalized weighted combination test of treatment effect for clinical trials with a sequential parallel comparison design and binary endpoint
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STATISTICS IN MEDICINE 2022年 第15期41卷 2725-2744页
作者: Quan, Hui Chen, Xiaofei Luo, Junxiang Chen, Xun Sanofi Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA Moderna Biostat & Programming Cambridge MA USA
To address the issue of a large placebo effect in certain therapeutic areas, rather than the application of the traditional gold standard parallel group placebo-controlled design, different versions of the sequential ... 详细信息
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A MCP-Mod approach to designing and analyzing survival trials with potential non-proportional hazards
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PHARMACEUTICAL STATISTICS 2022年 第6期21卷 1294-1308页
作者: Luo, Xiaodong Sun, Yuan Xu, Zhixing Sanofi Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA Sanofi Biostat & Programming Beijing Peoples R China
Non-proportional hazards have been observed in many studies especially in immuno-oncology clinical trials. Traditional analysis using the combined approach with log-rank test as the significance test and Cox model for... 详细信息
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A Bayesian method to detect drug-drug interaction using external information for spontaneous reporting system
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STATISTICS IN MEDICINE 2024年 第18期43卷 3353-3363页
作者: Tada, Keisuke Maruo, Kazushi Gosho, Masahiko Sanofi KK Biostat & Programming Shinjuku Ku Tokyo Japan Univ Tsukuba Inst Med Dept Biostat Tennodai 1-1-1 Tsukuba Ibaraki 3058575 Japan
Due to the insufficiency of safety assessments of clinical trials for drugs, further assessments are required for post-marketed drugs. In addition to adverse drug reactions (ADRs) induced by one drug, drug-drug intera... 详细信息
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A seamless phase II/III design with dose optimization for oncology drug development
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STATISTICS IN MEDICINE 2024年 第18期43卷 3383-3402页
作者: Li, Yuhan Zhang, Yiding Mi, Gu Lin, Ji Univ Illinois Dept Stat Champaign IL USA Sanofi US Dept Biostat & Programming Cambridge MA 02139 USA
The US FDA's Project Optimus initiative that emphasizes dose optimization prior to marketing approval represents a pivotal shift in oncology drug development. It has a ripple effect for rethinking what changes may... 详细信息
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Bivariate Bayesian hypothesis testing with missing data in components
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PHARMACEUTICAL STATISTICS 2022年 第2期21卷 395-417页
作者: Xu, Zhixing Quan, Hui Sanofi US Biostat & Programming Bridgewater NJ USA
Multiple endpoints and historical data borrowing may be simultaneously incorporated for enhancing efficiency and speeding up the new drug development process in the pharmaceutical industry. O'Brien's test is a... 详细信息
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Historical Control Data Borrowing for Noninferiority Assessment
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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2022年 第4期14卷 463-472页
作者: Quan, Hui Xu, Zhixing Cho, Meehyung Dong, Yingwen Jia, Nan Sanofi Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA
Noninferiority (NI) assessment is often performed to evaluate whether a test treatment can preserve certain proportion of the treatment effect of an active control compared to placebo. Two methods are usually applied ... 详细信息
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Regional consistency assessment in multiregional clinical trials
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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2024年 第6期34卷 973-985页
作者: Li, Gang Quan, Hui Wang, Yining Eisai Inc Global Med Affairs Nutley NJ USA Sanofi Biostat & Programming Bridgewater NJ USA Janssen Res & Dev Stat Programming Raritan NJ USA Eisai Inc Global Med Affairs 200 Metro Blvd Nutley NJ 07110 USA
Multiregional clinical trials (MRCTs) have become a favored strategy for new drug development. The accurate evaluation of treatment effects across different regions is crucial for interpreting the results of MRCTs. Co... 详细信息
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