医疗器械临床试验数据的统计分析方法建议

摘要

This paper provides an overview on data analysis of medical devices undergoing clinical trials during medical device evaluation. It reports some common questions occurred in study design phase and data analysis phase. Then the paper proposes some advice on data analysis methods for different types of products, which may provide technical references for reviewers and clinical data analysts.%该文概述了目前医疗器械技术审评过程中开展临床试验的产品的数据分析情况，提出了企业提交资料中临床试验数据统计分析存在的主要问题，从统计学的角度给出了不同类型产品的试验数据统计分析方法建议，为技术审评人员和临床试验数据统计分析人员提供技术参考。