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1、JOHNKooBypesoriPs园0JohnsHopkinsUniversityCoprigteiolJoweltskisieriyandlespoe川cheveredE东0巳FagL:一Firststageintestinganewinterventioninhumans一Usually10-30people一ldentifytolerabledose,provideinformationondrugmetabolismexcretion,andtoxicity一Oftennotcontrolled巳Fasl|:一Usualy30-100pbeople一Preliminaryinforma
2、tiononefficacy,additionalinformationonSafetyandsideeffects巳el一Usually100+people一Assessefficacyandsafety一ControlledusuallyrandomizedLectureOutline马icussvarioustrialdesigntypes一Parallet一Crossover一Groupallocation一Factorial一Largesimple一Equivalency一Non-inferioricy一AdaptiveJOHNSHOPKINSDEiuuousectonAJCompa
3、risonStructure:Parallelb,CrossoverandGroupAllocationDesignsEeL巳Snitaneoustreatmentandcontrolgroups巳Eachpersonisrandomlyassignedtoonetreatmentgroup巳Rtbmizationremovestreatmentselectionbiasandpromotescomparabitityoftreatmentgroups马86ticalcomparisonsmadebetweentreatmentgroupsEeuoeue(FRandomizedDDParall
4、elDesignExample:N巳bnalEmphysemaTeatmentTrial(NETT)一PhaselltriabunmaskedPopulationPeoplewithsevereemphysemaSamplesize1,200AllocationtotreatmentRandomizedTieatments-Luiigyotumeieductionsuigeryplusmedicaltherapy一Medicaltherapy(standardtherapycontrol)SourcesMETTfesearchGroup89J.Chest1999:116.175061iMEIT
5、fesearchGroup(1999)JThorcardioxeSrg118:518508;fehmanA,&Marinez.日吴弓003|.NEngIJMedH8:505873ParallelDesignExamplHypothesistestingSuperiorityOutcomes一Primary:mortality,exercisecapacity一Secondary:qualtityoftife,symptomstungfunctionandmechanics,functionalcapacityFollow-upUpto7.5yearsNumberoffzoruitigrcsit
6、cF7centersSourcesMETTfesearchGroup(99J.Chest1999;116.175061iMEITfesearchGroup(1999JThorcardioseg118:518.508;fehmanA,&Marinez.日吴人003|.HEngIJMedH8:2088738CrossoverDesign马Rrtbmizationoforderinwhichtreatmentsarereceived一ABorBA一Randomizationpromotesbalancebetweentreatmentgroupsitimingofexposure巳Testingofbothtreatmentsineachpatient一Eachpatientservyesashis/herowncontrol一Variabitityreducedbecauselessvariabilitywithinpatientthanbetweenbatienits巳FewerpatientsneededCrossoverDesignGraphGroup1,TXAGroup2,TXALECHLYMJL-C:yEHRA-Group2,TXBGroup1,TXB、_、_Washout
