clinicaltrials临床试验方案PPT学习教案

1、会计学1clinicaltrials临床试验方案临床试验方案NY/VI AETC第1页/共41页NY/VI AETC“sense of it”第2页/共41页NY/VI AETC第3页/共41页NY/VI AETC第4页/共41页NY/VI AETC Ex: Drug Trials第5页/共41页NY/VI AETCnSurvival AnalysisnRandomized Clinical Trial第6页/共41页NY/VI AETCfollowed over time第7页/共41页NY/VI AETCrisk for disease occurring during stated ti

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

3、ebo:Inactive pill w/ no therapeutic value第14页/共41页NY/VI AETCnPlan re: potential biasesnPlan re: handling of attrition/loss to follow up 第15页/共41页NY/VI AETCnAssign to one groupany timenEnrollment 100% voluntary 第16页/共41页NY/VI AETC第17页/共41页NY/VI AETC第18页/共41页NY/VI AETC第19页/共41页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页/共41页NY/VI AETCrisks第21页/共41页NY/VI AETCnEquitable selection of participantsnCompensation for study related injuries第22页/共41页NY/V

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

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