課程內容包括臨床試驗之研究問題(study question)、研究母群體(study population)、研究設計與隨機分配(basic study design and randomization process)、雙盲設計(blindness)、樣本數估算(sample size estimation)、研究起始點的評估(baseline assessment)、研究對象的網羅與醫學倫理(recruitment of study subjects & ethical issues)、資料收集與資料品質控制(data collection and quality control)、評估與報導副作用(assessment and reporting adverse effect)、生活品質之評估(assessment of quality of life)、遵醫性(subject compliance)、存活分析(survival analysis)、反應變項之監測(monitoring response variables)、資料分析之相關議題(issues in data analysis)、臨床試驗之結束(closeout)和臨床試驗結果的報導與解釋(reporting and interpretation of results)。
教學目標Course Objectives
介紹常用臨床試驗研究設計之原理與應用，以增進學生對臨床試驗研究設計之認識與應用，內容包括臨床試驗之組成及架構(如研究目的、重要性、對象、測量與統計方法)，與各組成應注意之項目與方法，以增進學生設計臨床試驗的能力。
The objective of this course is to provide an introduction to the theoretical consideration of clinical trial and its applications. The course is to help students how to design clinical trial and its applications. Course topics include compositions of research (objective, importance, population, measurement, and statistical analysis) and special consideration for these topics. It will help students to promote the ability of research design.