Advice on Data Analysis Methods for Clinical Trials of Medical Devices
10.3969/j.issn.1671-7104.2017.01.017
- VernacularTitle:医疗器械临床试验数据的统计分析方法建议
- Author:
Xiaohe YANG
1
;
Conghua JI
;
Qiong HE
;
Hui ZHEN
Author Information
1. 浙江省医疗器械审评中心
- Keywords:
medical devices;
clinical trials;
statistics
- From:
Chinese Journal of Medical Instrumentation
2017;41(1):63-65
- CountryChina
- Language:Chinese
-
Abstract:
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.
