Imputation of missing variance data using non-linear mixed effects modelling to enable an inverse variance weighted meta-analysis of summary-level longitudinal data: a case study [0.03%]
使用非线性混合效应模型填补缺失的方差数据以进行总结水平纵向数据的逆方差加权meta分析：一个案例研究
Martin Boucher
Martin Boucher
Missing variances, on the basis of the summary-level data, can be a problem when an inverse variance weighted meta-analysis is undertaken. A wide range of approaches in dealing with this issue exist, such as excluding data without a varianc...
Meta-Analysis
Pharmaceutical statistics. 2012 Jul-Aug;11(4):318-24. DOI:10.1002/pst.1515 2012
Rhiannon Maudsley,Ann Cleverly,Julia Harris
Rhiannon Maudsley
Establishing consistency across all regions in a multi-regional clinical trial [0.03%]
跨国临床试验各地区之间的一致性问题探究
Hsiao-Hui Tsou,H M James Hung,Yue-Ming Chen et al.
Hsiao-Hui Tsou et al.
In recent years, global collaboration has become a conventional strategy for new drug development. To accelerate the development process and shorten approval time, the design of multi-regional clinical trials (MRCTs) incorporates subjects f...
Comments on 'Application of an adaptive design to a randomized phase II selection trial in gastric cancer: a report of the study design' by Satoshi Morita and Junichi Sakamoto. Pharmaceutical Statistics [0.03%]
论著之评论作者:Satoshi Morita和Junichi Sakamoto药物流行病学
Md Monir Hossain,Zhongxue Chen
Md Monir Hossain
In this commentary, we show that the treatment selection probabilities in Morita and Sakamoto [1] could be different if safety information is considered. ...
Simon Kirby,Phil Brain,Byron Jones
Simon Kirby
We consider fitting Emax models to the primary endpoint for a parallel group dose–response clinical trial. Such models can be difficult to fit using Maximum Likelihood if the data give little information about the maximum possible response...
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...