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诊断试验样本含量估计需要考虑哪些参数

2025-04-01 23:40:33

推荐回答（1个）

回答1：

明确主要疗效指标并以此指标进行样本量估算，根据对照药、试验目的及相关注册要求确定是非劣效性检验还是等效、优效，由临床专家及统计专家根据既往结果、临床药效共同确定界值，至少在完成以上工作完成之后，才能由相应的公式计算出样本量。

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