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性研究 ?干預(yù) 施加一種或多種人為干預(yù)處理 ?隨機 研究對象隨機分配到比較組 ?對照 有平行的或可比的實驗組和對照組 ? Prospective ? Intervention or treatment ? Random allocation ? Paralleled control group Department of Epidemiology Public Health College of Harbin Medical University 9 四、實驗流行病學(xué)的類型 (types of experimental epidemiology) ? Clinical trial ? Field trial or field experiment ? Community trial. ?臨床試驗 ?現(xiàn)場試驗 ?社區(qū)試驗 Department of Epidemiology Public Health College of Harbin Medical University 10 (一 )個體試驗 (individual trial) 研究對象 (未患病者) 實驗組 (干預(yù)組) 對照組 有效 無效 有效 無效 Department of Epidemiology Public Health College of Harbin Medical University 11 (二)社區(qū)試驗 (munity trial) Department of Epidemiology Public Health College of Harbin Medical University 12 Field Trial or Field Experiment Effect of Hepatitis B Vaccine Against Hepatitis B infections of hepatitis B Children experiment group ( vaccine) control group (placebo) follow up 10 year (randomly) Department of Epidemiology Public Health College of Harbin Medical University 13 Community Trial (munity intervention trial) Fluoridation of Drinking Water to Prevent Saprodontia (randomly) munities Prevalence of saprodontia fluoridation of drinking water No fluoridation of drinking water Community A Community B Department of Epidemiology Public Health College of Harbin Medical University 14 (三)臨床試驗 (clinical trial) 研究對象 (病人) 實驗組 (干預(yù)組) 對照組 有效 無效 有效 無效 Department of Epidemiology Public Health College of Harbin Medical University 15 Clinical Trial Therapeutic Efficacy of Drug A effects of Drug A patients experiment group (Drug A) control group (placebo) follow up (randomly) Department of Epidemiology Public Health College of Harbin Medical University 16 Phases of Clinical Trials (FDA) ? Phase 1: Safety, Clinical pharmacology and toxicology 1530 people – What dosage is safe? – How should treatment be given? – How does treatment affect the body? ? Phase 2: Efficacy,Initial investigation for treatment effect Less than 100 people – Does treatment do what it is supposed to? – How does treatment affect the body? Department of Epidemiology Public Health College of Harbin Medical University 17 ? Phase 3: Effectiveness, Full scale evaluation of treatmen