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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