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检索条件"机构=Biostat and Programming"
418 条 记 录,以下是71-80 订阅
排序:
Rejoinder to Letter to the Editor on "A New Principal Stratum Estimand Investigating the Treatment Effect in Patients Who Would Comply, If Treated With a Specific Treatment"
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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2021年 第4期13卷 511-512页
作者: Larsen, Klaus Groes Josiassen, Mette Krog H Lundbeck & Co AS Dept Biostat & Programming Ottiliavej 9 DK-2500 Valby Denmark
"Rejoinder to Letter to the Editor on “A New Principal Stratum Estimand Investigating the Treatment Effect in Patients Who Would Comply, If Treated With a Specific Treatment”."Statistics in Biopharmaceutic...
来源: 评论
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
来源: 评论
Sequential designs for individualized dosing in phase I cancer clinical trials
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CONTEMPORARY CLINICAL TRIALS 2017年 63卷 51-58页
作者: Mao, Xuezhou Cheung, Ying Kuen Sanofi Biostat & Programming 55 Corp Dr Bridgewater MA 08807 USA Columbia Univ Dept Biostat 722 West 168 St New York NY 10032 USA
This paper addresses dose finding in clinical trials where individuals exhibit biologic characteristics that alter the toxicity risks of the individuals. In these situations, instead of determining a dose that works f... 详细信息
来源: 评论
Methods for Missing Data Handling in Phase III Clinical Trials with Nonnormal Endpoints and Nonnormal Covariates
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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2020年 第1期12卷 68-78页
作者: Fan, Chunpeng Wei, Lynn Koch, Gary G. Sanofi US Inc Dept Biostat & Programming 55 Corp Dr Bridgewater NJ 08807 USA Univ N Carolina Dept Biostat Chapel Hill NC 27515 USA
In randomized clinical trials, when the endpoint is the change from baseline at the last scheduled visit, various parametric, semiparametric, and nonparametric methods have been developed to handle the possible missin... 详细信息
来源: 评论
Semiparametric varying-coefficient regression analysis of recurrent events with applications to treatment switching
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STATISTICS IN MEDICINE 2018年 第27期37卷 3959-3974页
作者: Li, Yang Qi, Li Sun, Yanqing Univ North Carolina Charlotte Dept Math & Stat Charlotte NC 28223 USA Sanofi Biostat & Programming Bridgewater NJ USA
This paper investigates the semiparametric statistical methods for recurrent events. The mean number of the recurrent events are modeled with the generalized semiparametric varying-coefficient model that can flexibly ... 详细信息
来源: 评论
Planning the duration of a survival group sequential trial with a fixed follow-up time for all subjects
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COMMUNICATIONS IN STATISTICS-THEORY AND METHODS 2017年 第15期46卷 7460-7478页
作者: Liu, Yanning Janssen Res & Dev Quantitat Sci China Shanghai Peoples R China Janssen Res & Dev LLC Biostat & Programming Titusville NJ USA
To explore the operation characteristics of survival group sequential trials with a fixed follow-up period, the accrual time and total trial duration to ensure power and type I error rate requirements are explained an... 详细信息
来源: 评论
Design and monitoring of survival trials based on restricted mean survival times
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CLINICAL TRIALS 2019年 第6期16卷 616-625页
作者: Luo, Xiaodong Huang, Bo Quan, Hui Sanofi US Dept Biostat & Programming Res & Dev Bridgewater NJ 08807 USA Pfizer Inc New London CT USA
Background/Aims: Restricted mean survival time has become a popular treatment effect measurement because of its nice interpretability. However, study design based on restricted mean survival times often requires exten... 详细信息
来源: 评论
Blinded assessment of treatment effects for survival endpoint in an ongoing trial
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PHARMACEUTICAL STATISTICS 2012年 第3期11卷 204-213页
作者: Xie, Jun Quan, Hui Zhang, Ji Purdue Univ Dept Stat W Lafayette IN 47907 USA Sanofi Aventis Biostat & Programming Dept Bridgewater NJ 08807 USA
Many assumptions, including assumptions regarding treatment effects, are made at the design stage of a clinical trial for power and sample size calculations. It is desirable to check these assumptions during the trial... 详细信息
来源: 评论
Bias reduction using surrogate endpoints as auxiliary variables
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ANNALS OF THE INSTITUTE OF STATISTICAL MATHEMATICS 2019年 第4期71卷 837-852页
作者: Takagi, Yoshiharu Kano, Yutaka Sanofi KK Biostat & Programming Tokyo 1631488 Japan Osaka Univ Div Math Sci Grad Sch Engn Sci Toyonaka Osaka 5608531 Japan
Recently, it is becoming more active to apply appropriate statistical methods dealing with missing data in clinical trials. Under not missing at random missingness, MLE based on direct-likelihood, or observed likeliho... 详细信息
来源: 评论
Dose-finding studies, MCP-Mod, model selection, and model averaging: Two applications in the real world
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CLINICAL TRIALS 2014年 第4期11卷 476-484页
作者: Verrier, Dominique Sivapregassam, Sindou Solente, Anne-Catherine Sanofi R&D Biostat & Programming Dept F-34184 Montpellier France Inserm DGOS CIE 802 Ctr Invest Clin Epidemiol Clin Antilles Guyane Guyane France Sanofi R&D Dept Biostat & Programming Paris France
Background Phase II clinical trials are important milestones to determine whether a dose-effect exists and to decide on future doses to use in confirmatory studies. To take into account the overall shape of the dose r...
来源: 评论