University of the Free State, Bloemfontein, South Africa.
medac GmbH, Wedel, Germany.
Br J Clin Pharmacol. 2020 Jul;86(7):1240-1247. doi: 10.1111/bcp.14233. Epub 2020 Mar 3.
The recently finalised and published guideline ICH E9 (R1) introduced a new framework for the statistical analysis of clinical trials, namely that of "estimands". While the framework was originally developed for the analysis of late-phase trials, it could also provide a rigorous basis for the analysis of clinical pharmacology trials. We illustrate potential applications on two examples: a multiple dose pharmacology trial and the interpretation of confirmatory bioequivalence (BE) trials according to the current FDA and EMA BE guidelines.
最近定稿并发布的 ICH E9（R1）指南为临床试验的统计分析引入了一个新框架，即“目标”。虽然该框架最初是为后期试验的分析而开发的，但它也可以为临床药理学试验的分析提供严格的基础。我们通过两个例子来说明潜在的应用：一个多剂量药理学试验和根据当前 FDA 和 EMA BE 指南解释确证生物等效性（BE）试验。
