PUMC Epidemiology Network Meeting Beijing China December 16, 2006

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Presentation transcript:

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.

Disclosure and Disclaimer Employment: Merck & Co, Inc (2005 - ) US FDA (1998 - 2005) The opinions included herein are those of the presenter

Recent Drug Safety Events In the US

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

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

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

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

Issues #4: Is Risk Assessment Free of Risk 1. Picking the right risk 2. 2-4-6-8 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

Is Epidemiology Dangerous ? Epidemiology Faces Its Limits - Gary Taubes - Science July 14, 1995 Seven curable “Sins of Epidemiology” - Lewis Kuller - 1996 Presidential address in Society for Epidemiology Research Meeting

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

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

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