課程資訊
課程名稱
藥物流行病學
Pharmacoepidemiology 
開課學期
112-1 
授課對象
公共衛生學院  流行病學與預防醫學研究所  
授課教師
張家勳 
課號
EPM7166 
課程識別碼
849 M0610 
班次
 
學分
2.0 
全/半年
半年 
必/選修
選修 
上課時間
星期五3,4(10:20~12:10) 
上課地點
公衛211 
備註
與賴美淑合授
總人數上限:30人 
 
課程簡介影片
 
核心能力關聯
核心能力與課程規劃關聯圖
課程大綱
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課程概述

本課程將以近二十年來藥物安全與療效的重大事件,從當初發表於頂級期刊的經典研究,介紹藥物流行病學研究的實驗設計、分析、判讀、以及可能的干擾與偏誤,並由助教展示大型健康資料分析過程。希望能帶給同學研究上的啟發。
This is an introductory course on pharmacoepidemiology. How the principles of modern epidemiology methods are applied to evaluate safety, effectiveness, and utilization patterns of medical products (drugs, vaccines, and medical devices) will be discussed. Classic examples of descriptive epidemiology studies, cohort studies, case control studies, intervention studies, and meta-analysis will be drawn from famous papers from top medical journals to illustrate the application of relevant methods and the challenges in post-marketing medical product assessment. Perspectives from research institutions, medical product manufacturers, and regulatory agencies will be presented. Advanced methodology, such as propensity score, case-crossover and self-controlled case series design, target trial emulation, and time-series analysis will be briefly introduced. An TA session will demonstrate how to conduct a pharmacoepidemiological research by analyzing data from a healthcare claims database.
 

課程目標
C能利用流行病學資料作適當的推論。Draw appropriate inference from epidemiologic data
F能夠針對研究議題進行研究設計、適當地進行統計分析、做口頭報告,並有能力與其他領域的專家溝通的分析結果。Accomplish research design regarding a research topic, to appropriately conduct statistical analyses, to do oral presentation, and to communicate the analysis results with experts in other fields and general public.
了解FDA 如何批准藥物上市、監管藥物的安全性和有效性Understand how FDA approves drugs and regulates their safety and effectiveness
 
課程要求
Attend lectures, homework reading, class participation, and a term paper 
預期每週課後學習時數
 
Office Hours
另約時間 
指定閱讀
上課前宣佈 To be announced 
參考書目
ENCePP Guide on Methodological Standards in Pharmacoepidemiology
http://encepp.eu/standards_and_guidances/methodologicalGuide.shtml

Guidance for Industry and FDA Staff -- Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data
https://www.fda.gov/media/79922/download

EMA Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies, VIII Appendix 1. Methods for post-authorisation safety studies
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/20
12/06/WC500129137.pdf

Guidelines for Good Pharmacoepidemiology Practices (GPP)
https://www.pharmacoepi.org/resources/policies/guidelines-08027/
 
評量方式
(僅供參考)
 
No.
項目
百分比
說明
1. 
Attendance and participation 
80% 
 
2. 
Term paper 
20% 
 
 
課程進度
週次
日期
單元主題
第1週
9/08  Introduction
Overview of epidemiologic research methodology
Directed acyclic graphs (DAGs)
賴美淑 張家勳
 
第2週
9/15  Randomized controlled trials 張家勳 
第3週
9/22  Non-inferiority trial 張家勳 
第4週
9/29  中秋節 
第5週
10/06  What we have learned from the lesson of rosiglitazone? 張家勳 
第6週
10/13  The mystery of hormone replacement therapy:
Cohort study 張家勳 
第7週
10/20  The mystery of hormone replacement therapy:
Case-control study 張家勳 
第8週
10/27  Prevalent user bias 張家勳 
第9週
11/03  Immortal time bias 張家勳 
第10週
11/10  Selection bias (collider-stratification bias) 張家勳 
第11週
11/17  Propensity score methodology and inverse probability weighing 東雅惠 
第12週
11/24  Target trial emulation 賴嘉鎮 (webex 線上) 
第13週
12/01  Utilization study and interrupted time-series analysis:
ezetimibe and estrogen replacement therapy 張家勳 
第14週
12/08  How to critique a pharmacoepidemiologic study
How to design a pharmacoepidemiologic study 張家勳 
第15週
12/15  Real world evidence (在藥業的研究與使用概況) 邵文逸、葉怡君、 陳舒亭 、周煦文
 
第16週
12/22  Budget impact analysis ang cost-effectiveness analysis 黃莉茵