确证性试验 Confirmatory Trial

确证性试验是一种预先提出假设并进行评价的具有充分对照的试验。原则上，确证性试验需要提供有效性或安全性的确凿证据。¹⁾ 确证性试验要求提供主要指标的分析原则及预期分析方法。

A confirmatory trial is an adequately controlled trial in which the hypotheses are stated in advance and evaluated. As a rule, confirmatory trials are necessary to provide firm evidence of efficacy or safety. ²⁾