论文标题
在临床试验分析中使用历史个人数据
Use of Historical Individual Patient Data in Analysis of Clinical Trials
论文作者
论文摘要
来自先前临床试验的历史数据,观察性研究和健康记录可能用于分析临床试验数据以加强推理。根据贝叶斯框架的合并,从当前数据以外的任何来源获得的信息都可以通过构建提供信息的先验来促进。根据历史数据定义信息的现有方法依赖于在研究级别衡量与当前数据的相似性,并且不利用个别患者数据(IPD)。本文提出了一个利用IPD来加强统计推断的先验家族。已经证明,所提出的先前施工方法优于现有方法,其中历史数据可以与当前数据部分交换。该方法从非小细胞肺癌的一组试验中应用于IPD。
Historical data from previous clinical trials, observational studies and health records may be utilized in analysis of clinical trials data to strengthen inference. Under the Bayesian framework incorporation of information obtained from any source other than the current data is facilitated through construction of an informative prior. The existing methodology for defining an informative prior based on historical data relies on measuring similarity to the current data at the study level and does not take advantage of individual patient data (IPD). This paper proposes a family of priors that utilize IPD to strengthen statistical inference. It is demonstrated that the proposed prior construction approach outperforms the existing methods where the historical data are partially exchangeable with the present data. The proposed method is applied to IPD from a set of trials in non-small cell lung cancer.