The Choice Between Pearson's χ2 Test and Fisher's Exact Test for 2 × 2 Tables [0.03%]
2×2列联表中Pearson’s χ2检验与Fisher’s确切概率检验的选择
Markus Neuhäuser,Graeme D Ruxton
Markus Neuhäuser
Pearson's asymptotic χ2 test is often used to compare binary data between two groups. However, when the sample sizes or expected frequencies are small, the test is usually replaced by Fisher's exact test. Several alternative rules of thumb...
Comparative Study
Pharmaceutical statistics. 2025 May-Jun;24(3):e70012. DOI:10.1002/pst.70012 2025
Randomization in Pre-Clinical Studies: When Evolution Theory Meets Statistics [0.03%]
进化理论遇到统计学时，在临床前研究中随机化的应用
Sofia Weigle,Davit Sargsyan,Javier Cabrera et al.
Sofia Weigle et al.
Randomization is a statistical procedure used to allocate study subjects randomly into experimental groups while balancing continuous variables. This paper presents an alternative to random allocation for creating homogeneous groups by bala...
Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints [0.03%]
多重比较方法在联合主要终点分析和次要终点分析中的应用
Xiaolong Luo,Lerong Li,Oleksandr Savenkov et al.
Xiaolong Luo et al.
One of the main challenges in drug development for rare diseases is selecting the appropriate primary endpoints for pivotal studies. Although many endpoints can effectively reflect clinical benefit, their sensitivity often varies, making it...
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...