Attenuation of treatment effect due to measurement variability in assessment of progression-free survival [0.03%]
测量变异对无进展生存评估的影响：降低治疗效果
S Hong,N Schmitt,A Stone et al.
S Hong et al.
For normally distributed data analyzed with linear models, it is well known that measurement error on an independent variable leads to attenuation of the effect of the independent variable on the dependent variable. However, for time-to-eve...
Discussion on the paper 'Prediction of accrual closure date in multi-center clinical trials with discrete-time Poisson process models', by Gong Tang, Yuan Kong, Chung-Chou Ho Chang, Lan Kong, and Joseph P. Costantino [0.03%]
关于"Gong Tang等人所著的‘利用离散时间泊松过程模型预测多中心临床试验的结案日期’”一文的讨论
Vladimir V Anisimov
Vladimir V Anisimov
A proof-of-concept clinical trial design combined with dose-ranging exploration [0.03%]
一种初步概念性临床试验设计与剂量范围探索相结合的方法
Xin Wang,Naitee Ting
Xin Wang
In recent years, the pharmaceutical industry has experienced many challenges in discovering and developing new drugs, including long clinical development timelines with significant investment risks. In response, many sponsors are working to...
Testing bioequivalence for multiple formulations with power and sample size calculations [0.03%]
基于功效和样本量的多重处方等效性检验方法研究
Cheng Zheng,Jixian Wang,Lihui Zhao
Cheng Zheng
Bioequivalence (BE) trials play an important role in drug development for demonstrating the BE between test and reference formulations. The key statistical analysis for BE trials is the use of two one-sided tests (TOST), which is equivalent...
Confidence intervals for the difference of marginal probabilities in clustered matched-pair binary data [0.03%]
成对匹配的聚类二元数据边际概率差的置信区间
Zhao Yang,Xuezheng Sun,James W Hardin
Zhao Yang
Although there are several available test statistics to assess the difference of marginal probabilities in clustered matched-pair binary data, associated confidence intervals (CIs) are not readily available. Herein, the construction of corr...
Harry Southworth,Janet E Heffernan
Harry Southworth
Most clinical studies collect several safety-related laboratory variables. Generally, it is the extreme values of these variables that indicate potential safety issues. We illustrate the novel application of extreme value modelling to such ...
S Kirby,J Burke,C Chuang-Stein et al.
S Kirby et al.
Sample size planning is an important design consideration for a phase 3 trial. In this paper, we consider how to improve this planning when using data from phase 2 trials. We use an approach based on the concept of assurance. We consider ad...
Impact of safety monitoring on error probabilities of binary efficacy outcome analyses in large phase III group sequential trials [0.03%]
大型三期群序试验中安全监测对二分疗效终点假设检验犯错概率的影响分析
Yanqiu Weng,Wenle Zhao,Yuko Palesch
Yanqiu Weng
In phase III clinical trials, some adverse events may not be rare or unexpected and can be considered as a primary measure for safety, particularly in trials of life-threatening conditions, such as stroke or traumatic brain injury. In some ...
Qian Shi,Emily S Pavey,Rickey E Carter
Qian Shi
Multiple testing and its impact on the type I and type II error rates are frequently discussed in the statistical and biomedical literature. The Bonferroni adjustment is one of the most widely used approaches, yet it suffers from poor stati...