上市后藥品再評(píng)價(jià)杜文民11精選文檔

1、what we see is “tip of the unreported iceberg”causal associationexposureeventexposureestimateeventestimatestatistical associationrealityconfounding factorsbiasesevaluation: double challenge ?evaluation: double challenge sensitivity analyses modeling bayesian approach bayesian approach sick populatio

2、nresultstreatment target populationtreatment dissemination population= treated population?physician target populationeligible population study popintent to treatper protocol?drug-related populationsdrug-related questionssick populationphysician target populationeligible populationstudy population tr

3、eatment target populationtreatment distribution populationimpact on patients subgroupswished impact from treatmentpotential impact of treatmentreal impact of treatmentproportion of pop. available for treatment?generalizability?generalizability?recommendations?compliance?issuesperspectivesadr報(bào)告表報(bào)告表王x

4、x，男，69歲母親孕期服用己烯雌酚與女兒陰道腺癌的相關(guān)關(guān)系a+b+c+d（40）b+d（32）a+c（8）合計(jì)c+d（33）d（32）c（1）-a+b（7）b（0）a（7）+合計(jì)對(duì)照病例藥物dsru決定是否監(jiān)測新藥獲準(zhǔn)上市通知ppa挑出此藥的全部處方用藥的病人及處方醫(yī)生的詳細(xì)資料被送到dsru郵寄綠卡給醫(yī)生資料輸入到計(jì)算機(jī)綠卡返回到dsru資料分析資料分析，形成形成 pem 報(bào)告報(bào)告隨訪感興趣的，如：孕婦、死亡原因嚴(yán)重的、懷疑為adr的病人藥物流行病學(xué)研究方法藥物流行病學(xué)研究方法 描述性研究描述性研究 分析性研究分析性研究 實(shí)驗(yàn)性研究實(shí)驗(yàn)性研究 （干預(yù)實(shí)驗(yàn)）（干預(yù)實(shí)驗(yàn)） 現(xiàn)況調(diào)查現(xiàn)況調(diào)查 篩選

5、篩選 疾病監(jiān)測疾病監(jiān)測 病例對(duì)照研究病例對(duì)照研究 隊(duì)列研究隊(duì)列研究 社區(qū)實(shí)驗(yàn)社區(qū)實(shí)驗(yàn) 臨床實(shí)驗(yàn)臨床實(shí)驗(yàn) （縱向研究）（縱向研究） 群組病例對(duì)照研究群組病例對(duì)照研究 匹配病例對(duì)照研究匹配病例對(duì)照研究 前瞻性隊(duì)列前瞻性隊(duì)列 回顧性隊(duì)列回顧性隊(duì)列 雙向隊(duì)列雙向隊(duì)列 manufacturerssales or distributorshospitals or healthcare workersnew or serious in 15 daysdeath timely 15daysothers in each quarterregion centerscdr & national centernew /ser