Single-Arm Phase II Survival Trial Design Under the Proportional Hazards Model [0.03%]
比例风险模型下单臂二期生存试验设计
Jianrong Wu
Jianrong Wu
For designing single-arm phase II trials with time-to-event endpoints, a sample size formula is derived for the modified one-sample log-rank test under the proportional hazards model. The derived formula enables new methods for designing tr...
Confidence intervals for the difference of median failure times applied to censored tumor growth delay data [0.03%]
基于删失肿瘤生长数据的中位失效时间差的置信区间
Jianrong Wu
Jianrong Wu
In tumor xenograft experiments, tumor response to the anti-cancer agents is often assessed by tumor growth delay, the difference in median tumor quadrupling times between treatment and control. Tumor quadrupling time is often subjected to r...
Single-Arm Phase II Group Sequential Trial Design with Survival Endpoint at a Fixed Time Point [0.03%]
固定时间点生存终点的单臂二期分组序贯试验设计
Jianrong Wu,Xiaoping Xiong
Jianrong Wu
In this paper, three non-parametric test statistics are proposed to design single-arm phase II group sequential trials for monitoring survival probability. The small-sample properties of these test statistics are studied through simulations...
Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation [0.03%]
以结果为导向分析患者而不是以患者为导向分析结果：务实主义效益风险评估的一步
Scott R Evans,Dean Follmann
Scott R Evans
In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the total...
Transformation Model Choice in Nonlinear Regression Analysis of Fluorescence-based Serial Dilution Assays [0.03%]
荧光稀释系列滴定试验的非线性回归分析中的转换模型选择
Youyi Fong,Xuesong Yu
Youyi Fong
Many modern serial dilution assays are based on fluorescence intensity (FI) readouts. We study optimal transformation model choice for fitting five parameter logistic curves (5PL) to FI-based serial dilution assay data. We first develop a g...
Alexia Iasonos,John O&#x;Quigley
Alexia Iasonos
A rapidly increasing number of Phase I dose-finding studies, and in particular those based on the standard 3+3 design, are being prolonged with the inclusion of dose expansion cohorts (DEC) in order to better characterize the toxicity profi...
Commensurate Priors on a Finite Mixture Model for Incorporating Repository Data in Clinical Trials [0.03%]
一种有限混合模型的共先验在临床试验中纳入仓储数据的方法研究
Byron J Gajewski,C Shane Reese,John Colombo et al.
Byron J Gajewski et al.
Docosahexaenoic acid (DHA) is a good source of fat that can be taken up through food, such as fish, or taken as a supplement. Evidence is building that DHA provides a high yield, low risk strategy to reduce preterm birth and/or low birth we...
A Multi-state Model for Designing Clinical Trials for Testing Overall Survival Allowing for Crossover after Progression [0.03%]
一种用于设计检测总生存期的临床试验模型（进展后允许交叉）
Fang Xia,Stephen L George,Xiaofei Wang
Fang Xia
In designing a clinical trial for comparing two or more treatments with respect to overall survival (OS), a proportional hazards assumption is commonly made. However, in many cancer clinical trials, patients pass through various disease sta...
Bayesian Estimation and Testing in Random Effects Meta-analysis of Rare Binary Adverse Events [0.03%]
稀有二元不良事件的随机效应Meta分析的贝叶斯估计和检验
Ou Bai,Min Chen,Xinlei Wang
Ou Bai
Meta-analysis has been widely applied to rare adverse event data because it is very difficult to reliably detect the effect of a treatment on such events in an individual clinical study. However, it is known that standard meta-analysis meth...
Scott R Evans,Dean Follmann
Scott R Evans