本課程旨在建立學生對臨床試驗設計與統計分析的基礎認識，協助學生掌握進行臨床研究時所需之關鍵概念與方法。課程內容涵蓋臨床試驗的基本結構與流程，包含實驗設計（如平行組設計、交叉設計、分期試驗等）、隨機化程序、樣本數計算與統計推論方法。課程同時介紹衛福部食品藥物管理署（CDE）與美國食品藥物管理局（FDA）所公布的重要法規與指引，並透過實例講解其在試驗設計與審查流程中的應用。此外，課程亦將輔以實作練習，讓學生熟悉常用之統計分析工具與程式語法，以強化理論與實務的結合能力。This course aims to establish students' basic understanding of clinical trial design and statistical analysis, and help students master the key concepts and methods required for conducting clinical research. The course content covers the basic structure and process of clinical trials, including experiment design (such as parallel organization design, cross-design, installment trials, etc.), randomized procedures, sample calculations and statistical recommendation methods. The course also introduces important regulations and guidelines published by the Food and Drug Administration (CDE) and the U.S. Food and Drug Administration (FDA), and explains its application in the trial design and review process through examples. In addition, the course will also be practiced in practice, allowing students to familiarize themselves with commonly used statistical analysis tools and syntax to enhance the ability to combine theory and practice.
臨床統計是將臨床試驗中所需的統計方法加以介紹並說明如何應用。臨床試驗包含四個階段(Phase I~ Phase IV)，各階段所需的樣本數及有效性和安全性的衡量皆有對應的設計和統計方法來評估。介紹如何估計Phase I 及Phase II中最大安全劑量及Phase II-Phase III中最大安全劑量及最低有效劑量，並利用多重比較方法加以鑑別。針對試驗所收集的不同屬性資料，利用適當的統計方法加以分析。尤其當資料為存活時間資料，利用母數方法及無母數方法估計病人的存活情形及風險。當資料伴隨其他共變數時，利用半參數方法進行分析，探討共變數對病人存活時間的影響。
Clinical statistics are the introduction of the statistical methods required in the clinical trial and how to apply. The clinical trial consists of four stages (Phase I~ Phase IV). The number of samples required for each stage and the measurement of effectiveness and safety are evaluated according to the corresponding design and statistical methods. Introduce how to estimate the maximum safety dose in Phase I and Phase II, the maximum safety dose and the minimum effective dose in Phase II-Phase III, and distinguish it using multiple comparison methods. The different attribute data collected by the experiment were analyzed using appropriate statistical methods. Especially when the data is survival time data, the maternal method and the maternal method are used to estimate the patient's survival situation and risk. When data are accompanied by other covariates, the semi-parameter method is used for analysis to explore the impact of covariates on the patient's survival time.
1. 上課投影片
2. Yin G. Clinical Trial Design- Bayesian and Frequentist Adaptive Methods, Wiley, 2012.
1. Pre-class projection video
2. Yin G. Clinical Trial Design- Bayesian and Frequentist Adaptive Methods, Wiley, 2012.
| 評分項目 Grading Method | 配分比例 Grading percentage | 說明 Description |
|---|---|---|
| 期中考期中考 Midterm exam |
30 | |
| 期末考期末考 Final exam |
30 | |
| 作業作業 Action |
20 | |
| 小考小考 Small exam |
20 |
