A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design [0.03%]
一种两阶段的调整协变量的以疗效适应性的富集设计方法
Li Yang,Guoqing Diao,William F Rosenberger
Li Yang
In the precision medicine paradigm, it is of interest to identify subgroups that benefit most from the treatment. However, the subgroup often cannot be identified until after a large-scale clinical trial. Clinical trials are often designed ...
Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials [0.03%]
基于效用的贝叶斯最优区间设计在癌症药物联合试验中的剂量优化 Comb-BOIN12
Mengyi Lu,Jingyi Zhang,Ying Yuan et al.
Mengyi Lu et al.
Drug combinations are increasingly utilized in cancer treatment to enhance drug effectiveness through synergistic therapeutic effects. However, determining the optimal biological dose combination (OBDC) in small-scale drug combination trial...
Monitoring Ongoing Clinical Trials under Fractional Brownian Motion with Drift [0.03%]
漂移带分数布朗运动的临床试验监控方法研究
Peng Zhang,Weichung Joe Shih,Yong Lin et al.
Peng Zhang et al.
The standard Brownian motion (Bm) with a linear drift is a convenient statistical structure for monitoring ongoing clinical trials in practice for more than four decades (Lan and DeMets, 1983). Under this model, the most current one-point s...
Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes [0.03%]
联合的TITE-CRM设计：用于疗效和安全性结果均迟发的剂量探索试验
Helen Barnett,Oliver Boix,Dimitris Kontos et al.
Helen Barnett et al.
In Phase I/II dose-finding trials, the objective is to find the Optimal Biological Dose (OBD), a dose that is both safe and shows sufficient activity that maximizes some optimality criterion based on safety and activity. In cancer, treatmen...
MT-Keyboard: A Bayesian Model-assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials [0.03%]
基于贝叶斯模型的毒性分级和类型的I期临床试验区间设计——MT键盘设计
Kai Chen,Li Wang,Ying Yuan
Kai Chen
Conventionally, dose finding trials are based on dose-limiting toxicity (DLT) that only captures the most severe toxicities, e.g., treatment related grade 3 or higher toxicity according to the NCI Common Terminology Criteria for Adverse Eve...
Covariate-adaptive biased coin randomization for master protocols with multiple interventions and biomarker-stratified allocation [0.03%]
基于生物标志物分层分配的多介入主方案协变量自适应偏币随机化方法
Tianhao Song,Lisa M LaVange,Anastasia Ivanova
Tianhao Song
In a multi-arm trial with predefined subgroups for each intervention to target, it is often desirable to enrich assignment to an intervention by enrolling more biomarker-positive participants to the intervention. We describe how to implemen...
Bayesian Optimal Designs for Multi-Arm Multi-Stage Phase II Randomized Clinical Trials with Multiple Endpoints [0.03%]
具有多个终点的多臂分阶段二期随机临床试验的贝叶斯最优设计方法研究
Guillaume Mulier,Sylvie Chevret,Ruitao Lin et al.
Guillaume Mulier et al.
There is a growing need to evaluate of multiple competing drugs in phase II trials where the number of patients is often limited, and simultaneous assessment of both efficacy and toxicity is crucial. To avoid the waste of research resources...
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift [0.03%]
调整时间漂移的自适应平台试验中的治疗比较
Beibei Guo,Li Wang,Ying Yuan
Beibei Guo
An adaptive platform trial (APT) is a multi-arm trial in the context of a single disease where treatment arms are allowed to enter or leave the trial based on some decision rule. If a treatment enters the trial later than the control arm, t...
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial [0.03%]
序数结果在贝叶斯、响应自适应随机试验中的预期得分方法
Jonathan Beall,Jordan Elm,James Chamberlain et al.
Jonathan Beall et al.
Ordinal outcomes are common in medicine and can be analyzed in many ways, but the distribution of ordinal data can present unique challenges. The proposed KESETT study is a three-armed, randomized trial comparing two doses of ketamine plus ...
Ying Lu,Qian Zhao,Jiying Zou et al.
Ying Lu et al.
Complex disorders usually affect multiple symptom domains measured by several outcomes. The importance of these outcomes is often different among patients. Current approaches integrate multiple outcomes without considering patient preferenc...