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)
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E9:临床试验的统计学原则, ICH, 1998