临床试验设计的类型(1).ppt

LeaDrye,PhD,JohnsHopkinsUniversity,TypesofTrialDesign,Copyright2013JohnsHopkinsUniversityandLeaDrye.AllRightsReserved.,PhaseI:FirststageintestinganewinterventioninhumansUsually10-30peopleIdentifytolerabledose,provideinformationondrugmetabolism,excretion,andtoxicityOftennotcontrolledPhaseII:Usually30-100peoplePreliminaryinformationonefficacy,additionalinformationonsafetyandsideeffectsPhaseIII:Usually100+peopleAssessefficacyandsafetyControlled,usuallyrandomized2,Phasesoftrials,LectureOutline,DiscussvarioustrialdesigntypesParallelCrossoverGroupallocationFactorialLargesimpleEquivalencyNon-inferiorityAdaptive,3,ComparisonStructure:Parallel,Crossover,andGroup,AllocationDesigns,SectionA,Thematerialinthisvideoissubjecttothecopyrightoftheownersofthematerialandisbeingprovidedforeducationalpurposesunderrulesoffairuseforregisteredstudentsinthiscourseonly.Noadditionalcopiesofthecopyrightedworkmaybemadeordistributed.,ParallelDesign,5,SimultaneoustreatmentandcontrolgroupsEachpersonisrandomlyassignedtoonetreatmentgroupRandomizationremovestreatmentselectionbiasandpromotescomparabilityoftreatmentgroupsStatisticalcomparisonsmadebetweentreatmentgroups,|,P,叫,eG,巾,Randomized,占v,1，白,6,iJHSPH,ParallelDesignExample:NETT,Source:NETTResearchGroup(1999).Chest1999;116:1750-61;NETTResearchGroup(1999).JThoracCardiovascSurg,118:518-528;Fishman,A.,116:1750-61;NETTResearchGroup(1999).JThoracCardiovascSurg,118:518-528;Fishman,A.,1(8491):1169-73,PopulationPreschoolchildreninnorthernSumatrain1982-83TreatmentsVitaminAsupplementationduringstudyVitaminAsupplementationafterstudyClusters