Abstract

In addition to extensive preclinical testing, commercialization of medical devices in the United States under some circumstances may be supported with clinical data derived from single arm studies where the clinical endpoint is compared with a performance goal (PG). Since the performance is expected to be different between two clinically defined mutually exclusive patient subpopulations, the use of weighted PG is often adopted. In this article, we discuss the limitations of the current practice where weights need to be prespecified and fixed, and we propose an alternative approach that relaxes the fixed weight requirements.

中文翻译：

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在旨在评估医疗器械安全性和有效性的前瞻性单臂临床研究中使用加权性能目标

摘要

除了广泛的临床前测试外，在某些情况下，医疗器械在美国的商业化可能得到来自单臂研究的临床数据的支持，其中临床终点与性能目标 (PG) 进行比较。由于预计两个临床定义的相互排斥的患者亚群之间的性能不同，因此通常采用加权 PG。在本文中，我们讨论了当前需要预先指定和固定权重的做法的局限性，并提出了一种放宽固定权重要求的替代方法。