A Commensurate Prior Model With Random Effects for Survival and Competing Risk Outcomes to Accommodate Historical Controls [0.03%]
一种新的联合考虑生存结局和竞争风险的历史对照资料的随机效应共轭先验模型
Manoj Khanal,Brent R Logan,Anjishnu Banerjee et al.
Manoj Khanal et al.
Clinical trials (CTs) often suffer from small sample sizes due to limited budgets and patient enrollment challenges. Using historical data for the CT data analysis may boost statistical power and reduce the required sample size. Existing me...
Bayesian Sample Size Calculation in Small n, Sequential Multiple Assignment Randomized Trials (snSMART) [0.03%]
小型样本量的贝叶斯序贯多重赋权随机化试验中的样本量计算(snSMART)
Fang Fang,Roy N Tamura,Thomas M Braun et al.
Fang Fang et al.
A recent study design for clinical trials with small sample sizes is the small n, sequential, multiple assignment, randomized trial (snSMART). An snSMART design has been previously proposed to compare the efficacy of two dose levels versus ...
Zhaohua Lu,John Toso,Girma Ayele et al.
Zhaohua Lu et al.
In early phase drug development of combination therapy, the primary objective is to preliminarily assess whether there is additive activity from a novel agent when combined with an established monotherapy. Due to potential feasibility issue...
WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors [0.03%]
观看：评估临床试验发起人药物开发中治疗效果异质性的工作流程
Konstantinos Sechidis,Sophie Sun,Yao Chen et al.
Konstantinos Sechidis et al.
This article proposes a Workflow for Assessing Treatment effeCt Heterogeneity (WATCH) in clinical drug development targeted at clinical trial sponsors. WATCH is designed to address the challenges of investigating treatment effect heterogene...
A Phase I Dose-Finding Design Incorporating Intra-Patient Dose Escalation [0.03%]
一种结合单个受试者逐步增加剂量的I期剂量寻找设计
Beibei Guo,Suyu Liu
Beibei Guo
Conventional Phase I trial designs assign a single dose to each patient, necessitating a minimum number of patients per dose to reliably identify the maximum tolerated dose (MTD). However, in many clinical trials, such as those involving pe...
Zhiwei Zhang
Zhiwei Zhang
Dose-finding studies in oncology often include an up-and-down dose transition rule that assigns a dose to each cohort of patients based on accumulating data on dose-limiting toxicity (DLT) events. In making a dose transition decision, a key...
Flexible Spline Models for Blinded Sample Size Reestimation in Event-Driven Clinical Trials [0.03%]
事件驱动临床试验中盲态样本量重新估计的灵活样条模型方法研究
Tim Mori,Sho Komukai,Satoshi Hattori et al.
Tim Mori et al.
In event-driven trials, the target power under a certain treatment effect is maintained as long as the required number of events is obtained. The misspecification of the survival function in the planning phase does not result in a loss of p...
Confidence Intervals for the Risk Difference Between Secondary and Primary Infection Based on the Method of Variance Estimates Recovery [0.03%]
基于方差估计恢复法的二次和初次感染风险差异的置信区间
Chao Chen,Yuanzhen Li,Qitong Wei et al.
Chao Chen et al.
The risk difference (RD) between the secondary infection, given the primary infection, and the primary infection can be a useful measure of the change in the infection rates of the primary infection and the secondary infection. It plays an ...
Real Effect or Bias? Good Practices for Evaluating the Robustness of Evidence From Comparative Observational Studies Through Quantitative Sensitivity Analysis for Unmeasured Confounding [0.03%]
真效应还是偏倚？通过定量敏感性分析评估未测量的混杂因素对比较观察研究中的证据稳健性进行评价的良好实践
Douglas Faries,Chenyin Gao,Xiang Zhang et al.
Douglas Faries et al.
The assumption of "no unmeasured confounders" is a critical but unverifiable assumption required for causal inference yet quantitative sensitivity analyses to assess robustness of real-world evidence remains under-utilized. The lack of use ...
Bayesian Solutions for Assessing Differential Effects in Biomarker Positive and Negative Subgroups [0.03%]
贝叶斯解决方案：评估生物标志物阳性组和阴性组的差异效应
Dan Jackson,Fanni Zhang,Carl-Fredrik Burman et al.
Dan Jackson et al.
The number of clinical trials that include a binary biomarker in design and analysis has risen due to the advent of personalised medicine. This presents challenges for medical decision makers because a drug may confer a stronger effect in t...