One-sample and two-sample analysis of heterogeneous person-time data in clinical trials [0.03%]
临床试验中异质人群时间数据的一样本和两样本分析方法研究
Jing Xu,Michael LaValley
Jing Xu
In this paper, we investigate the performance of different parametric and nonparametric approaches for analyzing overdispersed person-time-event rates in the clinical trial setting. We show that the likelihood-based parametric approach may ...
Blinded assessment of treatment effects for survival endpoint in an ongoing trial [0.03%]
正在进行的临床试验中生存结局盲法评估治疗效果的方法学探索
Jun Xie,Hui Quan,Ji Zhang
Jun Xie
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 by using blinded data....
A practical comparison of blinded methods for sample size reviews in survival data clinical trials [0.03%]
生存数据临床试验中样本量再评审的盲法比较研究
Susan Todd,Elsa Valdés-Márquez,Jodie West
Susan Todd
This paper presents practical approaches to the problem of sample size re-estimation in the case of clinical trials with survival data when proportional hazards can be assumed. When data are readily available at the time of the review, on a...
An evaluation of methods for testing hypotheses relating to two endpoints in a single clinical trial [0.03%]
检验单个临床试验中两个结果之间假设的方法评估
Ting-Li Su,Ekkehard Glimm,John Whitehead et al.
Ting-Li Su et al.
The issues and dangers involved in testing multiple hypotheses are well recognised within the pharmaceutical industry. In reporting clinical trials, strenuous efforts are taken to avoid the inflation of type I error, with procedures such as...
Parallel, AA/BB, AB/BA and Balaam's design: efficient and maximin choices when testing the treatment effect in a mixed effects linear regression [0.03%]
并行、AA/BB、AB/BA和巴拉姆设计：在混合效应线性回归中检验治疗效果时的高效性和最大最小选择方法
Math J J M Candel
Math J J M Candel
When examining the effect of treatment A versus B, there may be a choice between a parallel group design, an AA/BB design, an AB/BA cross-over and Balaam's design. In case of a linear mixed effects regression, it is examined, starting from ...
A note on effective sample size for constructing confidence intervals for the difference of two proportions [0.03%]
关于构造两个比例差的置信区间的有效样本量的注记
Guanghan F Liu
Guanghan F Liu
Proportion differences are often used to estimate and test treatment effects in clinical trials with binary outcomes. In order to adjust for other covariates or intra-subject correlation among repeated measures, logistic regression or longi...
Ming T Tan,Xiaoping Xiong
Ming T Tan
Phase II trials evaluate whether a new drug or a new therapy is worth further pursuing or certain treatments are feasible or not. A typical phase II is a single arm (open label) trial with a binary clinical endpoint (response to therapy). A...
Ming T Tan,Xiaoping Xiong
Ming T Tan
Phase II trials evaluate whether a new drug or a new therapy is worth further pursuing or certain treatments are feasible or not. A typical phase II is a single arm (open label) trial with a binary clinical endpoint (response to therapy). A...
An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints [0.03%]
一种使用相关生存终点进行亚群体选择的适应性连续二期三期临床试验设计方案用于肿瘤试验
Martin Jenkins,Andrew Stone,Christopher Jennison
Martin Jenkins
Although the statistical methods enabling efficient adaptive seamless designs are increasingly well established, it is important to continue to use the endpoints and specifications that best suit the therapy area and stage of development co...
An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints [0.03%]
基于相关生存终点的适应性无缝期II/III临床试验设计及其在亚人群选择中的应用
Martin Jenkins,Andrew Stone,Christopher Jennison
Martin Jenkins
Although the statistical methods enabling efficient adaptive seamless designs are increasingly well established, it is important to continue to use the endpoints and specifications that best suit the therapy area and stage of development co...