clinicaltrials臨床試驗方案PPT學(xué)習(xí)教案

1、會計學(xué)1clinicaltrials臨床試驗方案臨床試驗方案NY/VI AETC第1頁/共41頁NY/VI AETC“sense of it”第2頁/共41頁NY/VI AETC第3頁/共41頁NY/VI AETC第4頁/共41頁NY/VI AETC Ex: Drug Trials第5頁/共41頁NY/VI AETCnSurvival AnalysisnRandomized Clinical Trial第6頁/共41頁NY/VI AETCfollowed over time第7頁/共41頁NY/VI AETCrisk for disease occurring during stated ti

2、me period.第8頁/共41頁NY/VI AETCof oranges & limes for scurvy 1747 第9頁/共41頁NY/VI AETC第10頁/共41頁NY/VI AETC第11頁/共41頁NY/VI AETCprocedures, and/or other interventions 第12頁/共41頁NY/VI AETC第13頁/共41頁NY/VI AETCHep. C = cases; others = controlsnProtocol:Study design - instructionsnot know group assignmentnPlac

3、ebo:Inactive pill w/ no therapeutic value第14頁/共41頁NY/VI AETCnPlan re: potential biasesnPlan re: handling of attrition/loss to follow up 第15頁/共41頁NY/VI AETCnAssign to one groupany timenEnrollment 100% voluntary 第16頁/共41頁NY/VI AETC第17頁/共41頁NY/VI AETC第18頁/共41頁NY/VI AETC第19頁/共41頁NY/VI AETC20 100Several

4、monthsMainly Safety70%Up to several 100Several months- 2 yrs.Short term safety; mainly effectiveness33%100s several 10001-4 yrs.Safety, dosage & effectiveness25-30%第20頁/共41頁NY/VI AETCrisks第21頁/共41頁NY/VI AETCnEquitable selection of participantsnCompensation for study related injuries第22頁/共41頁NY/V

5、I AETC第23頁/共41頁NY/VI AETC第24頁/共41頁NY/VI AETC第25頁/共41頁NY/VI AETC第26頁/共41頁NY/VI AETC第27頁/共41頁NY/VI AETCconflict of interest civil monetary penaltiesimproved monitoring of Phase I & II trials第28頁/共41頁NY/VI AETC第29頁/共41頁NY/VI AETC第30頁/共41頁NY/VI AETC第31頁/共41頁NY/VI AETC第32頁/共41頁NY/VI AETCooOutreach ac

6、tivities must take place to include & follow these groups第33頁/共41頁NY/VI AETC第34頁/共41頁NY/VI AETC第35頁/共41頁NY/VI AETCincentivesnSupportnOthers?time for study visitsnBarriers: lang., distance第36頁/共41頁NY/VI AETCcriteria?nBenefits & risksafter study is over?nHow results will be disseminated?第37頁/共41頁NY/VI AETC第38頁/共41頁NY/VI