[新版]循证医学与药物风行病学绳尺在美国fda药物风险评价中的应用.ppt

sdsds Drug Risk Assessment in US FDA – Applying the Principles of Evidence-Based Medicine and Pharmacoepidemiology循证医学与药物流行病学原则在美国FDA药物风险评估中的应用 Pharmacovigilence and Rational Drug Use 全国药物警戒与临床合理用药学术会议，中国 武汉 November 26, 2006 (2006年11月26日) Disclosure and Disclaimer (告知) Employment (工作单位): Merck Co, Inc 美国默克制药 (2005 - ) US FDA 美国FDA (1998 - 2005) The opinions included herein are those of the presenter (讲演者对讲演内容负责) Focus of the Presentation (报告的重点) It is NOT an introduction of US FDA risk assessment system (这不是关于美国FDA危险评估组织结构的报告) It is about fundamental thinking and basic concepts behind the risk assessment activities (这是一个关于理念的探讨) Drug Risk Assessment – A New Focus in China药物风险评估 - 中国的一个的新趋势 US FDA Risk Assessment/Management Guidance美国FDA风险评估及管理方面的指导原则 What is Drug Risk Assessment ？何为风险评估 ？ Drug Risk Assessment - Three Key Questions药物风险评估的三个中心问题 Is a medical event of interest drug-related? (因果关系) What is the magnitude of risk? (风险的大小程度) How can the risk be modified? (如何减少风险) What is Key Concern Here ?关注点何在 ？ Did vaccine cause SIDS in those child ? 该疫苗是否导致了这些孩子的新生儿悴死症？ A clinician’s perspective that leads to AE reporting, and a real question should be……. (这只是从临床学家的角度看问题) Can Vaccine Cause SIDS ? 该疫苗能否导致新生儿悴死症？ Which addresses causality from a public health perspective (这是从公共卫生的角度看问题) This is NOT an Easy Question Because…….这不是一个容易的问题， 因为…… Some medical events will occur coincidentally after medication use (background) 背景病例 - 病例的发生同用药偶合 The human brain excels at finding patterns and relationships, but tends to over-generalize 人的智慧使其善于发现规律和关联，但是也很容易使其轻易下结论 SIDS and Vaccination疫苗注射与新生儿悴死症 Four million births in the U.S. every year Sudden Infant Death Syndrome (SIDS) occurs (during the first year of life) at a rate of about 1/1500 in the U.S. Each year, 50-100 children can be expected to die by chance in any two-day period 美国每年有4百万新生儿，新生儿悴死症的发病1/1500。因此，每两天就会有50-100新生儿悴死症病例 Here Comes Phamacoepidemiology由此引进了药物流行病学 Take Home Message #1要点一： Pharm