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 ····································································...
