目标值法在医疗器械非随机对照临床试验中的应用

Objective Performance Criteria (OPC) in the Medical Devices Non-randomized Controlled Clinical Trials

目的探讨目标值法在医疗器械非随机对照临床试验中的应用。方法系统探讨目标值法的应用过程。由于样本含量在试验设计阶段的重要性,根据其统计思想演绎和推导出部分与其对应的样本量估计公式。结果应用目标值法完成的临床试验符合相关的统计学临床试验要求。结论目标值法可以用于医疗器械临床性能的评价研究,尤其适用于医疗器械的非随机对照临床试验。

Objective To explore the application of objective performance criteria （OPC or performance goals） in the medical devices non-randomized controlled chnical trials. Methods This paper discussed the OPC in details. Since sample size calculation is an important part of the design of the clinical trials, this paper highlighted and deduced some formulas of sample size calculation in OPC-based study. Results The clinical trial was successfully preformed by using objective performance criteria methodology. Condusion The objective performance criteria methodology can be used to evaluate the clinical performance of medical devices. It has turned out to be an adequate study design in some medical devices clinical trials, especially in the medical devices non-randomized controlled clinical trials.