Indirect comparisons in the comparative efficacy and non-inferiority settings [0.03%]
效用和非劣性试验中的间接比较方法
Steven Snapinn,Qi Jiang
Steven Snapinn
International Conference on Harmonization E10 concerns non-inferiority trials and the assessment of comparative efficacy, both of which often involve indirect comparisons. In the non-inferiority setting, there are clinical trial results dir...
Comparative Study
Pharmaceutical statistics. 2011 Sep-Oct;10(5):420-6. DOI:10.1002/pst.509 2011
Modeling data with structural and temporal correlation using lower level and higher level multilevel models [0.03%]
使用多层次模型的低层和高层建模具有结构和时间相关性的数据
Gareth James,Yinghui Zhou,Sam Miller
Gareth James
Novel imaging techniques are playing an increasingly important role in drug development, providing insight into the mechanism of action of new chemical entities. The data sets obtained by these methods can be large with complex inter-relati...
Randomized Controlled Trial
Pharmaceutical statistics. 2011 Sep-Oct;10(5):395-406. DOI:10.1002/pst.479 2011
Issues in the assessment of non-inferiority: perspectives drawn from case studies [0.03%]
非劣效性判断中的问题：从案例研究中得出的视角
H Ulrich Burger,Ulrich Beyer,Markus Abt
H Ulrich Burger
Superiority claims for improved efficacy are the backbone of clinical development of new therapies. However, not every new therapy in development allows for such a claim. Some therapies per se do not try to improve efficacy further but conc...
Christoph Gerlinger,Thomas Schmelter
Christoph Gerlinger
One of the cornerstones of any non-inferiority trial is the choice of the non-inferiority margin delta. This threshold of clinical relevance is very difficult to determine, and in practice, delta is often "negotiated" between the sponsor of...
The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians [0.03%]
美国食品药品监督管理局关于非劣效临床试验的草案指南——来自欧洲制药工业统计学者的评论
Bernhard Huitfeldt,Jürgen Hummel;European Federation of Statisticians in the Pharmaceutical Industry (EFSPI)
Bernhard Huitfeldt
The European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) engages more than 2000 statisticians through its ten national organizations. Amongst other things, EFSPI is involved in reviewing regulatory guidelines under de...
Steven A Julious
Steven A Julious
Steven A Julious
Steven A Julious
In a non-inferiority trial to assess a new investigative treatment, there may need to be consideration of an indirect comparison with placebo using the active control in the current trial. We can, therefore, use the fact that there is a com...
Frank W Rockhold,Gregory G Enas
Frank W Rockhold
Designing a non-inferiority study in kidney transplantation: a case study [0.03%]
一种肾脏移植的非劣性研究设计案例分析
Steffen Witte,Heinz Schmidli,Anthony O&#x;Hagan et al.
Steffen Witte et al.
In organ transplantation, placebo-controlled clinical trials are not possible for ethical reasons, and hence non-inferiority trials are used to evaluate new drugs. Patients with a transplanted kidney typically receive three to four immunosu...
Sue-Jane Wang,Jeffrey D Blume
Sue-Jane Wang
We present likelihood methods for defining the non-inferiority margin and measuring the strength of evidence in non-inferiority trials using the 'fixed-margin' framework. Likelihood methods are used to (1) evaluate and combine the evidence ...