探讨药物国际多中心临床试验设计的一种新方法SGDDP

发布时间：2018-03-25 22:46

本文选题：国际多中心临床试验　切入点：药物研发　出处：《中国新药杂志》2015年07期

【摘要】：在新药上市申请中,常常运用多地区开展的国际多中心临床试验(MRCT)数据和总体结果作为获准注册的主要证据。然而,对考察所涉及某个国家或地区的目标人群的药物效应时,却需要考虑种族因素和当地的医疗实践的影响,因此给评价和决策带来极大挑战。2012年,我们提出一种基于加权Z-检验的思路来设计MRCT的新方法,简称SGDDP。该方法结合来自目标种族人群和非目标种族人群(NTE)的信息,通过降低非目标种族人群在加权检验统计量中的信息权重,并严格控制统计假设的I类错误,从而检验评估在目标种族人群(TE)的有效性。本文对该方法进行简要介绍,并以最常用的连续型变量指标为例对研究所需的目标种族(TE)人群样本量进行了相应估算。
[Abstract]:In new drug marketing applications, data and overall results of international multi-center clinical trials conducted in multiple regions are often used as the main evidence for registration. However, when looking at the drug effects of a target population in a country or region, But we need to consider the impact of race and local medical practices, so it's a huge challenge to evaluate and make decisions. In 2012, we proposed a new way to design MRCT based on weighted Z- test. This method combines information from both target and non-target ethnic groups, reduces the information weight of non-target ethnic groups in weighted test statistics, and strictly controls class I errors in statistical assumptions. In this paper, the method is briefly introduced, and the most commonly used continuous variable index is taken as an example to estimate the sample size of the target race population.
【作者单位】：国家食品药品监督管理总局药品审评中心;北京师范大学数学科学学院;美国强生制药公司;
【分类号】：R95

【共引文献】