Using Off-Treatment Sequential Multiple Imputation for Binary Outcomes to Address Intercurrent Events Handled by a Treatment Policy Strategy [0.03%]
利用序贯多重填补处理间期事件的二分类结局：治疗政策策略应对方法
Sunita Rehal,Nicky Best,Sarah Watts et al.
Sunita Rehal et al.
The estimand framework proposes different strategies to address intercurrent events. The treatment policy strategy seems to be the most favoured as it is closely aligned with the pre-addendum intention-to-treat principle. All data for all p...
A Tobit Partly Linear Mixed and Mixture Cure Model for the Joint Analysis of Interval-Bounded Longitudinal Measurements and Survival Times With Cure Proportion [0.03%]
具有治愈比例的区间界定纵向测量和生存时间的Tobit部分线性混合和混合 cure 模型
Zhanfeng Wang,Zerui Shen,Ruixing Ming et al.
Zhanfeng Wang et al.
Motivated by the analysis of data from a clinical trial on patients with early breast cancer, we propose in this paper a new joint model that uses a Tobit partly linear mixed model for longitudinal measurements which are bounded in an inter...
Application of Causal Inference to Establish Assay Effect in the Absence of a Bridging Study: A Case Study of MenACWY-CRM Conjugate Vaccine Data [0.03%]
因果推断在缺乏桥接研究时建立检测方法效应的应用：MenACWY-CRM结合疫苗数据的案例研究
Meike Adani,Silvia Noirjean,Andrea Callegaro et al.
Meike Adani et al.
During a vaccine development program, if the assay used to measure immunological endpoints is changed, ideally, a bridging study is performed to establish the relationship between results obtained with the new and previous assay. However, t...
Multiple Comparisons With Overdispersed Multinomial Data: Methods, Properties and Application [0.03%]
过度离散的多项式数据的多重比较：方法、性质和应用
Sören Budig,Charlotte Vogel,Frank Schaarschmidt
Sören Budig
Overdispersion, a common issue in clustered multinomial data, can lead to biased standard errors and compromised statistical inference if not adequately addressed. This study describes a comprehensive procedure for constructing multiple com...
Comparative Study
Pharmaceutical statistics. 2026 Jan-Feb;25(1):e70073. DOI:10.1002/pst.70073 2026
Informing the Borrowing Process for Dose-Finding Trials by Estimating the Similarity Between Population-Specific Dose-Toxicity Curves [0.03%]
通过估计特定人群剂量-毒性曲线之间的相似性来告知借入法在剂量寻找试验中的应用
Dario Zocholl,Heiko Götte,Christina Habermehl et al.
Dario Zocholl et al.
The conduct of dose-finding trials can be specifically challenging in small populations, for example, in pediatric settings. Recently, research has shown that Bayesian borrowing from adult trials combined with appropriately robust prior dis...
Dominic Magirr,Fredrik Öhrn
Dominic Magirr
The introduction of checkpoint inhibitors in immuno-oncology has raised questions about the suitability of the log-rank test as the default primary analysis method in confirmatory studies, particularly when survival curves exhibit non-propo...
A Tree-Based Scan Statistic for Detecting Signals of Drug-Drug Interactions in Spontaneous Reporting Databases [0.03%]
一种基于树的扫描统计量可检测自发报告数据库中药品相互作用信号
Seok-Jae Heo,Inkyung Jung
Seok-Jae Heo
The concomitant use of multiple drugs increases the risk of adverse events (AEs) due to drug-drug interactions (DDIs), which remain challenging to identify since clinical trials primarily focus on individual drugs, necessitating postmarket ...
Optimizing Dosing Strategies in Cell Therapy With Machine Learning and Exposure-Response Integration [0.03%]
基于暴露-反应整合的机器学习细胞治疗剂量策略优化方法
Shuqi Wang,Yunqi Zhao,Jia Li et al.
Shuqi Wang et al.
In cell therapy product development, cell expansion is highly correlated with response and safety. Significant heterogeneity in patient and product characteristics contributes to variability in cell expansion, persistence and response. Inte...
Prospectively Specified Adaptive Bayesian Borrowing: Considerations, Methodologies, and Implementations [0.03%]
自适应贝叶斯借鉴的前瞻性指定：考虑因素、方法和实施路径
Saurabh Mukhopadhyay,Yujie Zhao,Xiaotian Chen et al.
Saurabh Mukhopadhyay et al.
In clinical research, it is increasingly difficult to conduct fully powered and well-balanced randomized controlled trials, particularly when studying rare or devastating diseases and pediatric patients. While Bayesian methodologies are ver...
Selection of Quantitative Decision-Making Criteria Using Weighted Decision Error Rates [0.03%]
基于加权决策误差率的定量决策准则选择
Daniel J Bratton
Daniel J Bratton
Quantitative decision-making frameworks provide objective criteria for advancing a drug development program. Within this process, two types of decision error can occur: proceeding to the next phase and failing (incorrect go) or not proceedi...