The effect of variability and carryover on average bioequivalence assessment: a simulation study [0.03%]
变异性及残留效应对平均生物等效性评价的影响：基于模拟试验的分析
María Pilar O Sánchez,Jordi Ocaña,Josep L Carrasco
María Pilar O Sánchez
The purpose of this study was to evaluate the effect of residual variability and carryover on average bioequivalence (ABE) studies performed under a 22 crossover design. ABE is usually assessed by means of the confidence interval inclusion ...
Adaptive blinded sample size adjustment for comparing two normal means--a mostly Bayesian approach [0.03%]
一种比较两个正态均值的自适应盲样本量调整方法：主要基于贝叶斯的方法
Andrew M Hartley
Andrew M Hartley
Adaptive sample size redetermination (SSR) for clinical trials consists of examining early subsets of on-trial data to adjust prior estimates of statistical parameters and sample size requirements. Blinded SSR, in particular, while in use a...
Stability criteria for the outcomes of statistical tests to assess drug effectiveness with a single study [0.03%]
单一研究评价药物疗效的统计检验结果稳定性的评判标准
Daniele De Martini
Daniele De Martini
At least two adequate and well-controlled clinical studies are usually required to support effectiveness of a certain treatment. In some circumstances, however, a single study providing strong results may be sufficient. Some statistical sta...
A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints [0.03%]
多重主要终点的临床试验样本量计算的一个简便公式
Tomoyuki Sugimoto,Takashi Sozu,Toshimitsu Hamasaki
Tomoyuki Sugimoto
The clinical efficacy of a new treatment may often be better evaluated by two or more co-primary endpoints. Recently, in pharmaceutical drug development, there has been increasing discussion regarding establishing statistically significant ...
Stefan Englert,Meinhard Kieser
Stefan Englert
Clinical phase II trials in oncology are conducted to determine whether the activity of a new anticancer treatment is promising enough to merit further investigation. Two-stage designs are commonly used for this situation to allow for early...
Propensity score applied to survival data analysis through proportional hazards models: a Monte Carlo study [0.03%]
倾向值在生存数据分析中通过比例风险模型的应用：一个蒙特卡罗研究
Etienne Gayat,Matthieu Resche-Rigon,Jean-Yves Mary et al.
Etienne Gayat et al.
Propensity score methods are increasingly used in medical literature to estimate treatment effect using data from observational studies. Despite many papers on propensity score analysis, few have focused on the analysis of survival data. Ev...
Kimberly S Crimin,Joseph W McKean,Thomas J Vidmar
Kimberly S Crimin
During drug development, the calculation of inhibitory concentration that results in a response of 50% (IC50) is performed thousands of times every day. The nonlinear model most often used to perform this calculation is a four-parameter log...
A general method to determine sampling windows for nonlinear mixed effects models with an application to population pharmacokinetic studies [0.03%]
非线性混合效应模型确定取样窗口的通用方法及其在人群药代动力学研究中的应用
Lee Kien Foo,James McGree,Stephen Duffull
Lee Kien Foo
Optimal design methods have been proposed to determine the best sampling times when sparse blood sampling is required in clinical pharmacokinetic studies. However, the optimal blood sampling time points may not be feasible in clinical pract...
Prediction of accrual closure date in multi-center clinical trials with discrete-time Poisson process models [0.03%]
基于离散时间泊松过程模型的多中心临床试验结算截止日期预测
Gong Tang,Yuan Kong,Chung-Chou Ho Chang et al.
Gong Tang et al.
In a phase III multi-center cancer clinical trial or a large public health study, sample size is predetermined to achieve desired power, and study participants are enrolled from tens or hundreds of participating institutions. As the accrual...
Michael J Sweeting,Adrian P Mander
Michael J Sweeting
Phase I clinical trials aim to identify a maximum tolerated dose (MTD), the highest possible dose that does not cause an unacceptable amount of toxicity in the patients. In trials of combination therapies, however, many different dose combi...