A Tipping Point Method to Evaluate Sensitivity to Potential Violations in Missing Data Assumptions [0.03%]
评估缺失数据假设潜在违规性的敏感性的一种转折点方法
Cesar Torres,Gregory Levin,Daniel Rubin et al.
Cesar Torres et al.
It is critical to evaluate the sensitivity of conclusions from a clinical trial to potential violations in the missing data assumptions of the statistical analysis. Sensitivity analyses should not consist of a few methods that might have be...
Using Subject Level Covariate Information in Bayesian Mixture Models for Basket Trials [0.03%]
贝叶斯混合模型在篮式试验中利用受试者水平协变量信息
Sneha Govande,Elizabeth H Slate
Sneha Govande
Basket trials are gaining importance with advancements in precision medicine. A basket trial evaluates one or more treatments for efficacy among more than one cancer type (histology) in a single clinical trial. Compared to traditional desig...
Interval Estimation for the Youden Index and Optimal Cut-Off Point in AUC-Based Optimal Combinations of Multivariate Normal Biomarkers With Covariates [0.03%]
基于AUC最优组合的多变量正态生物标志物与共变量的Youden指数和最佳临界值的区间估计
Hossein Nadeb,Yichuan Zhao
Hossein Nadeb
In this article, we present interval estimation methods for the Youden index and the optimal cut-off point in the context of AUC-based optimal combinations of multivariate normally distributed biomarkers, considering the presence of covaria...
Using Propensity Score Weighting to Enhance the Operating Characteristics of Power Prior in Leveraging External Data to Augment a Traditional Clinical Study [0.03%]
使用倾向得分加权来提高功率先验的运行特性，以利用外部数据扩充传统临床研究
Heng Li,Wei-Chen Chen,Chenguang Wang et al.
Heng Li et al.
The method of power prior has long been used as a tool for leveraging external data to augment a traditional clinical study. More recently, it has been found that integrating propensity scoring into its application has the potential for imp...
Yasutaka Chiba
Yasutaka Chiba
A new measure was recently developed in the context of survival analysis that can be interpreted as a weighted arithmetic mean of the hazards with the survival function as the weight. However, when the average hazard is desired, it is more ...
BF-BOIN-ET: A Backfill Bayesian Optimal Interval Design Using Efficacy and Toxicity Outcomes for Dose Optimization [0.03%]
BF-BOIN-ET：一种使用有效性和毒性结果进行剂量优化的填充贝叶斯最优区间设计
Kentaro Takeda,Jing Zhu,Akihiro Hirakawa
Kentaro Takeda
The primary purpose of a dose-finding trial for novel anticancer agents is to identify an optimal dose (OD), defined as the tolerable dose that has adequate efficacy in unpredictable dose-toxicity and dose-efficacy relationships. The FDA pr...
Estimation Methods for Estimands Using the Treatment Policy Strategy; a Simulation Study Based on the PIONEER 1 Trial [0.03%]
使用治疗策略估计估量的方法；基于PIONEER 1试验的模拟研究
James Bell,Thomas Drury,Tobias Mütze et al.
James Bell et al.
Estimands using the treatment policy strategy for addressing intercurrent events are common in Phase III clinical trials. One estimation approach for this strategy is retrieved dropout whereby observed data following an intercurrent event a...
Dong Xi,Jiangtao Gou
Dong Xi
Project FrontRunner encourages development of cancer drugs for advanced or metastatic disease in an earlier clinical setting by promoting regulatory approaches such as the accelerated approval pathway. The FDA draft guideline proposes a one...
Approximate Bayesian Analysis for Borrowing External Controls for Randomized Controlled Trials With Dynamic Borrowing and Covariate Balancing Adjustment [0.03%]
随机对照试验中利用动态借用和协变量平衡调整借用外部对照的近似贝叶斯分析
Jixian Wang,Ram Tiwari
Jixian Wang
Borrowing controls from external sources has become popular for augmenting the control arm in small randomized controlled trials (RCTs). Due to the difference between the external and RCT populations, bias can be introduced that may lead to...