Bayesian Response Adaptive Randomization for Randomized Clinical Trials With Continuous Outcomes: The Role of Covariate Adjustment [0.03%]
基于协变量调整的连续型疗效指标的贝叶斯适应性随机化临床试验设计方法研究
Vahan Aslanyan,Trevor Pickering,Michelle Nuño et al.
Vahan Aslanyan et al.
Study designs incorporate interim analyses to allow for modifications to the trial design. These analyses may aid decisions regarding sample size, futility, and safety. Furthermore, they may provide evidence about potential differences betw...
Comparison of Prior Distributions for the Heterogeneity Parameter in a Rare Events Meta-Analysis of a Few Studies [0.03%]
基于少量研究的稀有事件元分析中异质性参数先验分布的比较
Minghong Yao,Fan Mei,Kang Zou et al.
Minghong Yao et al.
Bayesian meta-analysis is a promising approach for rare events meta-analysis. However, the inference of the overall effect in rare events meta-analysis is sensitive to the choice of prior distribution for the heterogeneity parameter. Theref...
Yilong Zhang,Yujie Zhao,Bingjun Wang et al.
Yilong Zhang et al.
In covariate-adaptive or response-adaptive randomization, the treatment assignment and outcome can be correlated. Under this situation, the re-randomization test is a straightforward and attractive method to provide valid statistical infere...
Lei Yang,Feinan Lu
Lei Yang
Several indices were suggested to determine the follow up duration in oncology trials from either maturity or stability perspective, by maximizing time t $$ t $$ such that the index was either greater or less than a pre-defined cutoff val...
An Adaptive Three-Arm Comparative Clinical Endpoint Bioequivalence Study Design With Unblinded Sample Size Re-Estimation and Optimized Allocation Ratio [0.03%]
一种自适应三臂比较临床终点生物等效性研究设计：不设盲样本量再估算和优化分配比例
David Hinds,Wanjie Sun
David Hinds
A three-arm comparative clinical endpoint bioequivalence (BE) study is often used to establish bioequivalence (BE) between a locally acting generic drug (T) and reference drug (R), where superiority needs to be established for T and R over ...
Assessing the Operational Characteristics of the Individual Causal Association as a Metric of Surrogacy in the Binary Continuous Setting [0.03%]
二元和连续设置中作为替代标志度量的个体因果关联的操作特征评估
Fenny Ong,Geert Molenberghs,Andrea Callegaro et al.
Fenny Ong et al.
In a causal inference framework, a new metric has been proposed to quantify surrogacy for a continuous putative surrogate and a binary true endpoint, based on information theory. The proposed metric, termed the individual causal association...
Jonathan Jones,Bairu Zhang,Xiang Zhang et al.
Jonathan Jones et al.
Quality by Design (QbD) is an approach to assay development to determine the design space, which is the range of assay variable settings that should result in satisfactory assay quality. Typically, QbD is applied in manufacturing, but it wo...
Mauro Gasparini
Mauro Gasparini
I would like to reconsider a recent analysis by Prof. Senn on the statistics of the Pfizer-BioNTech vaccine trial, to express some different opinions and to clarify some theoretical points, especially regarding the clinical applications of ...
Propensity Score Analysis With Baseline and Follow-Up Measurements of the Outcome Variable [0.03%]
结合结局变量基线和随访观测的倾向值分析方法研究
Peter C Austin
Peter C Austin
A common feature in cohort studies is when there is a baseline measurement of the continuous follow-up or outcome variable. Common examples include baseline measurements of physiological characteristics such as blood pressure or heart rate ...
Generalizing Treatment Effect to a Target Population Without Individual Patient Data in a Real-World Setting [0.03%]
在现实世界环境中没有个体患者数据的情况下将处理效果推广到目标人群
Hui Quan,Tong Li,Xun Chen et al.
Hui Quan et al.
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 patient data (IPD) col...