Comment on "Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic" [0.03%]
关于“大流行期间开展的临床试验中的统计问题与建议”的评论
Sylva H Collins,Mark S Levenson
Sylva H Collins
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic [0.03%]
新冠肺炎疫情期间临床试验的统计问题与建议
R Daniel Meyer,Bohdana Ratitch,Marcel Wolbers et al.
R Daniel Meyer et al.
Abstract-The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed...
Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic [0.03%]
COVID-19大流行期间进行和管理临床试验的统计挑战
Toshimitsu Hamasaki,Frank Bretz,Freda Cooner et al.
Toshimitsu Hamasaki et al.
A clinical trial design with covariate-adjusted response-adaptive randomization using superiority confidence of treatments [0.03%]
基于治疗优越性概率的协变量调整型随机适应试验设计
Wei Qiao,Jing Ning,Xuelin Huang
Wei Qiao
Adaptive randomization using response outcome or covariate are commonly used in the literature. However, the performance of these designs has not been thoroughly studied, especially when there are various interactions between the covariate ...
Effects of Proportional Hazard Assumption on Variable Selection Methods for Censored Data [0.03%]
比例风险假定对截尾数据变量选择方法的影响分析
Alvin Sheng,Sujit K Ghosh
Alvin Sheng
The Cox proportional hazard (PH) model is widely used to determine the effects of risk factors and treatments (covariates) on survival time of subjects that might be right censored. The selection of covariates depends crucially on the speci...
Statistical Considerations for Sequential Analysis of the Restricted Mean Survival Time for Randomized Clinical Trials [0.03%]
序贯分析随机临床试验中受限均生存时间的统计学考量
Ying Lu,Lu Tian
Ying Lu
In this paper, we illustrate the method of designing a group-sequential randomized clinical trial based on the difference in restricted mean survival time (RMST). The procedure is based on theoretical formulations of Murray and Tsiatis (199...
Improvement in the Analysis of Vaccine Adverse Event Reporting System Database [0.03%]
疫苗不良事件报告系统数据库分析的改进
Lili Zhao,Sunghun Lee,Rongxia Li et al.
Lili Zhao et al.
As a national public health surveillance resource, Vaccine Adverse Event Reporting System (VAERS) is a key component in ensuring the safety of vaccines. Numerous methods have been used to conduct safety studies with the VAERS database. Thes...
Interim Monitoring for Futility in Clinical Trials with Two Co-primary Endpoints Using Prediction [0.03%]
具有两个协同主要终点的临床试验中基于预测的无效期中期监测
Koko Asakura,Scott R Evans,Toshimitsu Hamasaki
Koko Asakura
We discuss using prediction as a flexible and practical approach for monitoring futility in clinical trials with two co-primary endpoints. This approach is appealing in that it provides quantitative evaluation of potential effect sizes and ...
Gary L Rosner
Gary L Rosner
Regulatory science comprises the tools, standards, and approaches that regulators use to assess safety, efficacy, quality, and performance of drugs and medical devices. A major focus of regulatory science is the design and analysis of clini...
A Bayesian Sequential Design for Clinical Trials with Time-to-Event Outcomes [0.03%]
临床试验中基于时间结果的Bayesian序贯设计方法研究
Lin Zhu,Qingzhao Yu,Donald E Mercante
Lin Zhu
There is increasing interest in Bayesian group sequential design because of its potential to improve efficiency in clinical trials, to shorten drug development time, and to enhance statistical inference precision without undermining the cli...