Andrew P Grieve
Andrew P Grieve
The topic of this article is pre-posterior distributions of success or failure. These distributions, determined before a study is run and based on all our assumptions, are what we should believe about the treatment effect if we are told onl...
Beyond the Fragility Index [0.03%]
脆弱性指数之外
Piero Quatto,Enrico Ripamonti,Donata Marasini
Piero Quatto
The results of randomized clinical trials (RCTs) are frequently assessed with the fragility index (FI). Although the information provided by FI may supplement the p value, this indicator presents intrinsic weaknesses and shortcomings. In th...
Potential Bias Models With Bayesian Shrinkage Priors for Dynamic Borrowing of Multiple Historical Control Data [0.03%]
基于贝叶斯收缩先验的潜在偏倚模型在多重历史对照数据动态借入中的应用研究
Tomohiro Ohigashi,Kazushi Maruo,Takashi Sozu et al.
Tomohiro Ohigashi et al.
When multiple historical controls are available, it is necessary to consider the conflicts between current and historical controls and the relationships among historical controls. One of the assumptions concerning the relationships between ...
Yan Sun,A S Hedayat
Yan Sun
Precision medicine is the future of drug development, and subgroup identification plays a critical role in achieving the goal. In this paper, we propose a powerful end-to-end solution squant (available on CRAN) that explores a sequence of q...
A Model-Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology [0.03%]
一种基于模型的试验设计，采用考虑药代动力学暴露量的随机化方案以优化肿瘤药物剂量
Jun Zhang,Kentaro Takeda,Masato Takeuchi et al.
Jun Zhang et al.
The primary purpose of an oncology dose-finding trial for novel anticancer agents has been shifting from determining the maximum tolerated dose to identifying an optimal dose (OD) that is tolerable and therapeutically beneficial for subject...
A Bayesian Dynamic Model-Based Adaptive Design for Oncology Dose Optimization in Phase I/II Clinical Trials [0.03%]
一种贝叶斯动态模型的自适应设计在I/II期肿瘤药物剂量优化中的应用
Yingjie Qiu,Mingyue Li
Yingjie Qiu
With the development of targeted therapy, immunotherapy, and antibody-drug conjugates (ADCs), there is growing concern over the "more is better" paradigm developed decades ago for chemotherapy, prompting the US Food and Drug Administration ...
Prediction Intervals for Overdispersed Poisson Data and Their Application in Medical and Pre-Clinical Quality Control [0.03%]
过度离散泊松数据的预测区间及其在医疗和临床前质量控制中的应用
Max Menssen,Martina Dammann,Firas Fneish et al.
Max Menssen et al.
In pre-clinical and medical quality control, it is of interest to assess the stability of the process under monitoring or to validate a current observation using historical control data. Classically, this is done by the application of histo...
Optimizing Sample Size Determinations for Phase 3 Clinical Trials in Type 2 Diabetes [0.03%]
二型糖尿病三期临床试验样本量的确定优化研究
Alexander C Cambon,James Travis,Liping Sun et al.
Alexander C Cambon et al.
An informed estimate of subject-level variance is a key determinate for accurate estimation of the required sample size for clinical trials. Evaluating completed adult Type 2 diabetes studies submitted to the FDA for accuracy of the varianc...
Dan Jackson,Michael Sweeting,Rose Baker
Dan Jackson
'Treatment effect measures under nonproportional hazards' by Snapinn et al. (Pharmaceutical Statistics, 22, 181-193) recently proposed some novel estimates of treatment effect for time-to-event endpoints. In this note, we clarify three poin...
PKBOIN-12: A Bayesian Optimal Interval Phase I/II Design Incorporating Pharmacokinetics Outcomes to Find the Optimal Biological Dose [0.03%]
一种新的基于药代动力学指标的I/II期临床试验两阶段设计：Bayesian optimal interval (BOIn)设计的拓展及应用
Hao Sun,Jieqi Tu
Hao Sun
Immunotherapies and targeted therapies have gained popularity due to their promising therapeutic effects across multiple treatment areas. The focus of early phase dose-finding clinical trials has shifted from finding the maximum tolerated d...