Ring Arne, Schall Robert, Loke Yoon K, Day Simon
University of the Free State, Bloemfontein, South Africa.
medac GmbH, Wedel, Germany.
Br J Clin Pharmacol. 2017 Jun;83(6):1159-1162. doi: 10.1111/bcp.13254. Epub 2017 Mar 21.
Research in clinical pharmacology covers a wide range of experiments, trials and investigations: clinical trials, systematic reviews and meta-analyses of drug usage after market approval, the investigation of pharmacokinetic-pharmacodynamic relationships, the search for mechanisms of action or for potential signals for efficacy and safety using biomarkers. Often these investigations are exploratory in nature, which has implications for the way the data should be analysed and presented. Here we summarize some of the statistical issues that are of particular importance in clinical pharmacology research.
临床药理学研究涵盖广泛的实验、试验和调查：临床试验、药品上市后使用情况的系统评价和荟萃分析、药代动力学-药效学关系的研究、利用生物标志物寻找作用机制或疗效及安全性的潜在信号。这些研究往往具有探索性，这对数据的分析和呈现方式具有影响。在此，我们总结一些在临床药理学研究中特别重要的统计学问题。
