1. PUMC Epidemiology Network Meeting Beijing China December 16, 2006
From The Challenges of Drug Risk Assessment In US FDA to See the Needs of Promoting Pharmacoepidemiology Development In China
Zili Li, MD, MPH, Director,
Clinical Research Operations – Asia Pacific,
Merck & Co, Inc.

2. Disclosure and Disclaimer
Employment:
Merck & Co, Inc ( )
US FDA ( )
The opinions included herein are those of the presenter

3. Recent Drug Safety Events In the US

4. Appropriate Use of Epidemiology and Evidence-Based Medicine in Drug Risk Assessment
Meta-Analysis 荟萃分析
RCT
随机对照试验
Case Series
病例观察
Cohort Study
队列研究
Expert Opinion
专家意见
Case-Control Study
病例对照研究

5. Issue #1: Is Expert Opinion Important ?
专家意见
Case-Control Study
病例对照研究
Cohort Study
队列研究
RCT
随机对照试验
Case Series
病例观察
Meta-Analysis 荟萃分析

6. Issue #2: Is Evidence-Based Medicine a Criteria ?

7. Issue #3: What is the Focus of Causality Assessment ?
Question
Did vaccine cause SIDS in those child ?
Can vaccine cause SIDS ?

8. Issues #4: Is Risk Assessment Free of Risk
1. Picking the right risk
What can we associate
3. The Significance of significance
4. “Data” collection
5. Mining for statistical associations
6. The Mixmaster technique
7. Instant risk
8. The big risk number
9. Cooking up biological plausibility
10. Peer “review”
11. The final document
12. Where to publish
13. Dealing with criticism

9. Is Epidemiology Dangerous ?
Epidemiology Faces Its Limits
- Gary Taubes - Science July 14, 1995
Seven curable “Sins of Epidemiology”
- Lewis Kuller Presidential address in Society for Epidemiology Research Meeting

10. US FDA Risk Assessment/Management Guidance
The slide shows the titles of three US FDA’s risk assessment & management guidance

11. Drug Risk Assessment – A New Focus and Opportunity For Epidemiologists in China

12. More Information