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LeaDrye,PhDJohnsHopkinsUniversityTypesofTrialDesignCopyright?2013JohnsHopkinsUniversityandLeaDrye.AllRightsReserved.2021/3/29星期一1
?? PhaseI:FirststageintestinganewinterventioninhumansUsually10-30peopleIdentifytolerabledose,provideinformationondrugmetabolism,excretion,andtoxicityOftennotcontrolled?? PhaseII:Usually30-100peoplePreliminaryinformationonefficacy,additionalinformationonsafetyandsideeffects?? PhaseIII:Usually100+peopleAssessefficacyandsafetyControlled,usuallyrandomized2Phasesoftrials2021/3/29星期一2
LectureOutline?? DiscussvarioustrialdesigntypesParallelCrossoverGroupallocationFactorialLargesimpleEquivalencyNon-inferiorityAdaptive32021/3/29星期一3
ComparisonStructure:Parallel,Crossover,andGroupAllocationDesignsSectionAThematerialinthisvideoissubjecttothecopyrightoftheownersofthematerialandisbeingprovidedforeducationalpurposesunderrulesoffairuseforregisteredstudentsinthiscourseonly.Noadditionalcopiesofthecopyrightedworkmaybemadeordistributed.2021/3/29星期一4
ParallelDesign?? Simultaneoustreatmentandcontrolgroups?? Eachpersonisrandomlyassignedtoonetreatmentgroup?? Randomizationremovestreatmentselectionbiasandpromotescomparabilityoftreatmentgroups?? Statisticalcomparisonsmadebetweentreatmentgroups2021/3/29星期一5
|P叫ωe G巾Randomized「占v1，白iJHSPH2021/3/29星期一6
ParallelDesignExample:NETTSource:NETTResearchGroup(1999).Chest1999;116:1750-61;NETTResearchGroup(1999).JThoracCardiovascSurg,118:518-528;Fishman,A.,Martinez,F.,etal.(2003).NEnglJMed348:2059-73.?? NationalEmphysemaTreatmentTrial(NETT)- PhaseIIItrial,unmaskedPopulationPeoplewithsevereemphysemaSamplesize1,200AllocationtotreatmentRandomizedTreatments—Lungvolumereductionsurgeryplusmedicaltherapy—Medicaltherapy(standardtherapycontrol)2021/3/29星期一7
ParallelDesignExample:NETTSource:NETTResearchGroup(1999).C
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