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随着国内外临床试验适应性设计指导原则的发布，在临床试验中设计期中分析，对临床试验的成功与否，具有很大的指导意义，它不但有助于提高研发效率，而且，对一些临床试验选择了不正确的统计方法，从而导致I类错误膨胀、引入偏倚等严重问题，可能引起临床试验失败有重要防范意义。本文结合目前临床试验中出现的3个案例，对确证性临床试验期中分析相关统计学问题进行了分析与总结，促进了对期中分析的深入理解，为确证性临床试验进行高质量地设计、实施、分析和结果解释提供参考。

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