====== 确证性试验 Confirmatory Trial ======

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　　**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。(([[法规:临床试验的统计学原则#试验背景|E9：临床试验的统计学原则]], [[概念:ICH]], 1998)) 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. (([[https://database.ich.org/sites/default/files/E9_Guideline.pdf|E9: Statistical Principles for Clinical Trials]], [[概念:ICH]], 1998))

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