摘要
目的:为科学设计医疗器械的临床试验,合理选择试验样本含量。方法:利用统计方法对医疗器械临床试验的样本含量计算进行探讨,并结合一些案例进行分析。结果:提供了常用统计参数的样本含量查询表,所提出的计算方法经验证方便可行。结论:医疗器械临床试验样本含量可通过查询表方式快捷获取。
Objective To plan clinical trials of medical instruments reasonably and select suitable sample size of the trial. Methods The calculation methods of sample size were studied with statistical methods. Moreover, some cases were enumerated and analyzed. Results Some kinds of consulted tables were designed and offered with common statistical parameters. The proposed methods proved to be feasible. Conclusion The sample size of medical instruments in clinical trials can be rapidly gotten by the consultation tables.
出处
《医疗卫生装备》
CAS
2012年第7期18-20,34,共4页
Chinese Medical Equipment Journal
关键词
样本量
临床试验
医疗器械
sample size
clinical trial
medical instruments
