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e after drug is approved – Used to further evaluate longterm safety and effectiveness of new treatment Department of Epidemiology Public Health College of Harbin Medical University 18 應該注意的問題 Issues should be paid attention to ? 臨床依從性 cliccal pliance ? 臨床不一致性 clinical disagreement ? 安慰劑效應 placebo effect ? 向均數(shù)回歸 regression to the mean Department of Epidemiology Public Health College of Harbin Medical University 19 現(xiàn)場試驗與臨床試驗比較 注意 ! Difference Between Filed Trial and Clinical Trial Department of Epidemiology Public Health College of Harbin Medical University 20 現(xiàn)場試驗與臨床試驗比較 Difference Between Filed Trial and Clinical Trial Department of Epidemiology Public Health College of Harbin Medical University 21 真實驗 true experiment 按所具備設計的基本特征 ( basic features) 真實驗 (true experiment) 對照 前瞻 干預 隨機 randomization prospective control intervention Department of Epidemiology Public Health College of Harbin Medical University 22 類實驗 quasiexperiment 按所具備設計的基本特征 ( basic features) 類實驗 (quasiexperiment) 真實驗 (true experiment) 對照 前瞻 干預 隨機 ? 不設對照組 ( without control group) ? 自身前后比較 ? 與已知干預措施比較 ? 設對照組 ( with control group) ? 不能隨機分組 Department of Epidemiology Public Health College of Harbin Medical University 23 第二節(jié) 研究設計與實施 Design and Execution Department of Epidemiology Public Health College of Harbin Medical University 24 ? 一 明確研究目的 ? 二 研究對象的選擇 ? 三 確定實驗現(xiàn)場 ? 四 樣本大小的確定 ? Purpose ? Object ? Experimental spot ? Sample Department of Epidemiology Public Health College of Harbin Medical University 25 四、樣本量估計 ( estimate the quantity of the samples) ? 非連續(xù)變量 Noncontinuous variable ? 連續(xù)變量 Continuous variable 22122211)pp(])p1(p)p1(pZ)p1(p2Z[N??????? ??222)(2dZZN a????Department of Epidemiology Public Health College of Harbin Medical University 26 五、隨機化分組 ( randomization) ? 簡單隨機分組 Simple Randomization ? 分層隨機分組 Stratified Randomization ? 整群隨機分組 Cluster Randomization Department of Epidemiology Public Health College of Harbin Medical University 27 簡單隨機分組 (simple Randomization) Department of Epidemiology Public Health College of Harbin Medical University 28 ? Simple Randomization Department of Epidemiology Public Health College of Harbin Medical University 29 分層隨機分組 (stratified randomization) 總體 層 層 層 可按年齡、性別、種族、教育水平