H-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 20070823.docVIP

精品资料 精品资料 PAGE / NUMPAGES 精品资料 指导原则编号：【 H 】G C L 4 - 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