临床试验设计的类型(1).ppt

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1、LeaDrye,PhDJohnsHopkinsUniversityTypesofTrialDesignCopyright©2013JohnsHopkinsUniversityandLeaDrye.AllRightsReserved.PhaseI:FirststageintestinganewinterventioninhumansUsually10-30peopleIdentifytolerabledose,provideinformationondrugmetabolism,excretion,andtoxici

2、tyOftennotcontrolledPhaseII:Usually30-100peoplePreliminaryinformationonefficacy,additionalinformationonsafetyandsideeffectsPhaseIII:Usually100+peopleAssessefficacyandsafetyControlled,usuallyrandomized2PhasesoftrialsLectureOutlineDiscussvarioustrialdesignty

3、pesParallelCrossoverGroupallocationFactorialLargesimpleEquivalencyNon-inferiorityAdaptive3ComparisonStructure:Parallel,Crossover,andGroupAllocationDesignsSectionAThematerialinthisvideoissubjecttothecopyrightoftheownersofthematerialandisbeingprovidedforeducationa

4、lpurposesunderrulesoffairuseforregisteredstudentsinthiscourseonly.Noadditionalcopiesofthecopyrightedworkmaybemadeordistributed.ParallelDesign5SimultaneoustreatmentandcontrolgroupsEachpersonisrandomlyassignedtoonetreatmentgroupRandomizationremovestreatments

5、electionbiasandpromotescomparabilityoftreatmentgroupsStatisticalcomparisonsmadebetweentreatmentgroups

6、P叫ωeG巾Randomized「占v1，白6iJHSPHParallelDesignExample:NETTSource:NETTResearchGroup(1999).Chest1999;116:1750-61;NETTResearchGroup(1999).JThoracCardiovascSurg,118:

7、518-528;Fishman,A.,&Martinez,F.,etal.(2003).NEnglJMed348:2059-73.7NationalEmphysemaTreatmentTrial(NETT)-PhaseIIItrial,unmaskedPopulationPeoplewithsevereemphysemaSamplesize1,200AllocationtotreatmentRandomizedTreatments—Lungvolumereductionsurgeryplusmedicalthera

8、py—Medicaltherapy(standardtherapycontrol)ParallelDesignExample:NETTSource:NETTResearchGroup(1999).Chest1999;116:1750-61;NETTResearchGroup(1999).JThoracCardiovascSurg,118:518-528;Fishman,A.,&Martinez,F.,etal.(2003).NEnglJMed348:2059-73.8HypothesistestingSuperiori

9、tyOutcomes—Primary:mortality,exercisecapacity—Secondary:qualityoflife,symptoms,lungfunctionandmechanics,functionalcapacityFollow-upUpto7.5yearsNumberofrecruitingcente