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指导原则编号 【H】GCL4-1
化学药物和生物制品临床试验的生物统计学
技术指导原则
二 五年三月
目录
一、概述······················································································································1
二、整个临床试验的基本考虑··················································································1
(一)探索性试验和确证性试验····················································································1
(二)观察指标················································································································2
(三)偏倚的控制············································································································4
三、试验设计中的基本考虑······················································································8
(一)试验设计的类型····································································································8
(二)多中心试验··········································································································10
(三)比较的类型··········································································································10
(四)样本量··················································································································11
(五)资料的收集··········································································································12
四、试验进行中的基本考虑····················································································12
(一)期中分析··············································································································12
(二)试验方案的修改··································································································13
五、数据管理············································································································13
六、统计分析······································································
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