中国临床药理学杂志2016，Vol.32Issue(5)：469-472,4.DOI:10.13699/j.cnki.1001-6821.2016.05.027
临床试验缺失数据的统计学考量
Statistical considerations on missing data in clinical trials
王骏 1韩景静 1黄钦1
作者信息
- 1. 国家食品药品监督管理总局 药品审评中心，北京 100038
- 折叠
摘要
Abstract
Missing data is a common and important issue in clinical tri-als.It could make the results difficult to be explained , even influence the inference and conclusion of the trial.Currently , not enough emphasis has been given to the problem in China.In the real world of statistical opera-tion in dealing with clinical trial missing data , sponsors often applied va-rious methods without any rational , which introduced many difficulties for evaluating and confirming the safety and efficacy of new drugs.In this paper , three real cases were specifically brought out for illustration and analysis , meanwhile , the prevention of missing data , the choice of esti-mator , statistical analysis methods and sensitivity analysis were also discussed.The aim is to attract the sponsors to focus attention on prevention and treatment of missing data in clinical trials.关键词
临床试验/缺失数据/统计学Key words
clinical trial/missing data/statistics分类
药学引用本文复制引用
王骏,韩景静,黄钦..临床试验缺失数据的统计学考量[J].中国临床药理学杂志,2016,32(5):469-472,4.
