临床试验设计的类型.ppt

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LeaDrye,PhDJohnsHopkinsUniversityTypesofTrialDesignCopyright?2013JohnsHopkinsUniversityandLeaDrye.AllRightsReserved.

?? PhaseI:FirststageintestinganewinterventioninhumansUsually10-30peopleIdentifytolerabledose,provideinformationondrugmetabolism,excretion,andtoxicityOftennotcontrolled?? PhaseII:Usually30-100peoplePreliminaryinformationonefficacy,additionalinformationonsafetyandsideeffects?? PhaseIII:Usually100+peopleAssessefficacyandsafetyControlled,usuallyrandomized2Phasesoftrials

LectureOutline?? DiscussvarioustrialdesigntypesParallelCrossoverGroupallocationFactorialLargesimpleEquivalencyNon-inferiorityAdaptive3

ComparisonStructure:Parallel,Crossover,andGroupAllocationDesignsSectionAThematerialinthisvideoissubjecttothecopyrightoftheownersofthematerialandisbeingprovidedforeducationalpurposesunderrulesoffairuseforregisteredstudentsinthiscourseonly.Noadditionalcopiesofthecopyrightedworkmaybemadeordistributed.

ParallelDesign6?? Simultaneoustreatmentandcontrolgroups?? Eachpersonisrandomlyassignedtoonetreatmentgroup?? Randomizationremovestreatmentselectionbiasandpromotescomparabilityoftreatmentgroups?? Statisticalcomparisonsmadebetweentreatmentgroups

|P叫ωe G巾Randomized「占v1，白7iJHSPH

ParallelDesignExample:NETTSource:NETTResearchGroup(1999).Chest1999;116:1750-61;NETTResearchGroup(1999).JThoracCardiovascSurg,118:518-528;Fishman,A.,Martinez,F.,etal.(2003).NEnglJMed348:2059-73.8?? NationalEmphysemaTreatmentTrial(NETT)- PhaseIIItrial,unmasked

ParallelDesignExample:NETTSource:NETTResearchGroup(1999).Chest1999;116:1750-61;NETTResearchGroup(1999).JThoracCardiovascSurg,118:518-528;Fishman,A.,Martinez,F.,etal.(2003).NEnglJMed348:2059-73.9

CrossoverDesign10?? RandomizationoforderinwhichtreatmentsarereceivedABorBARandomizationpromotesbalancebet