Helen Barnett,Melanie Guhl,Fulvio Di Stefano et al.
Helen Barnett et al.
Leveraging preclinical prior information has the potential to enhance the efficiency of Phase I oncology trials if used appropriately. In this paper, a comparison of the meta-analytic predictive (MAP) prior approach and the power prior appr...
A Dose-Finding Design for Drug Combinations Using a Bayesian 4 Parameter Logistic Model With Penalised D-Optimality [0.03%]
Maxine Ajimi,Benjamin Webb,Graham M Wheeler et al.
Maxine Ajimi et al.
Drug combinations, where two drugs are co-administered, are being explored widely within Phase I trials in oncology. These trials aim to identify the maximum tolerated dose combination (MTDC) by adapting the dose of both treatments based on...
RABOTS: A Randomized Adaptive Bayesian Optimization Two-Stage Seamless Design for Dose Optimization and Proof-of-Concept Evaluation [0.03%]
Xiaochen Zhu,Yiwei Li,Jiaju Wu et al.
Xiaochen Zhu et al.
Dose optimization (DO) is a significant paradigm in clinical trials, with the goal of identifying an optimal dose that preserves maximal efficacy while minimizing toxicity. In this paper, we propose a Randomized Adaptive Bayesian Optimizati...
A Seamless Two-Stage Phase I/II Trial Design With Backfill and Joint Monitoring for Dose Optimization [0.03%]
Kentaro Takeda,Jing Zhu,Belay B Yimer et al.
Kentaro Takeda et al.
The FDA's Project Optimus initiative emphasizes dose optimization through randomized cohorts and comprehensive evaluation across dose levels. Additionally, early-phase oncology trials must efficiently evaluate antitumor activity while maint...
Consistency Assessment and Regional Sample Size Calculation for MRCT Under Random Effects Model [0.03%]
随机效应模型下的MRCT的一致性评价及区样本量计算
Xinru Ren,Jin Xu
Xinru Ren
Multi-regional clinical trials (MRCTs) have become common practice for drug development and global registration. Once overall significance is established, demonstrating regional consistency is critical for local health authorities. Methods ...
A Constrained Hierarchical Bayesian Model Considering Latent Biomarker Subgroups for Time-To-Event Endpoints in Randomized Phase II Trials [0.03%]
考虑潜在生物标志物亚组的时间终点的随机II期试验的受限层次贝叶斯模型
Yifei Huang,Kentaro Takeda,Yongyun Zhao
Yifei Huang
In randomized Phase III oncology trials, the long-term time-to-event endpoint is the most relevant outcome for participants and regulators. However, in Phase II trials, the short-term binary outcome of tumor response is often used as a surr...
Unblinded by the Night: Predictive Power for Complex Bayesian Adaptive Trials When Sight Privileges Vary [0.03%]
复杂贝叶斯自适应试验的预测能力当视野特权不同时夜盲者的夜晚：当视野特权不同时复杂贝叶斯自适应试验的预测能力
Byron J Gajewski,Jonathan Beall,Kaustubh Nimkar et al.
Byron J Gajewski et al.
Well-controlled clinical trials employ careful processes to reduce bias, often blinding investigators and sponsors to prevent knowledge of study outcomes and potential operational bias. Quality assurance of outcomes is also ensured through ...
Paired and AB/BA Cross-Over Design in Early Phase Clinical Trials: A Closer Look at Within-Subject Variance Bias [0.03%]
早期临床试验中配对和AB/BA交叉设计的组内变异偏倚研究
Martin J Wolfsegger,Peixin Xu,Amy Cotterill et al.
Martin J Wolfsegger et al.
This manuscript advocates for the implementation of multiple-sequence cross-over designs in early-phase clinical trials by investigating the bias in within-subject variance present in paired and AB/BA cross-over clinical trial designs. Whil...
Bayesian Power-Based Sample Size Determination for Single-Arm Clinical Trials With Time-to-Event Endpoints [0.03%]
基于幂的贝叶斯样本量重新估计在以生存率为终点的单臂临床试验中的应用研究
Go Horiguchi,Isao Yokota,Satoshi Teramukai
Go Horiguchi
The purpose of an exploratory clinical trial is to determine whether a new treatment is worth evaluating in subsequent trials. These trials often assessed the efficacy and safety of a single-arm design with binary outcomes. In cancer therap...
An Association Test for Ordinal Outcomes in Clustered Data With Informative Cluster Size [0.03%]
具有信息聚类规模的群组数据中有序结果的关联性检验
Hasika K Wickrama Senevirathne,Sandipan Dutta
Hasika K Wickrama Senevirathne
In cluster-correlated data, the number of observations in a cluster can be associated with the outcome from that cluster. This phenomenon is known as informative cluster size which can occur in cluster-randomized clinical trial data. Severa...