clinical trials 临床试验方案.ppt

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1、UnderstandingClinicalTrialsDevelopedbySaraBack,NPBronx-LebanonHospitalCenterNY/VIAETCOverviewPurposeofResearchStudiesClassificationsofEpidemiologicalResearchBasicResearchTerminologyFeaturesofClinicalTrialsDesign/ProtocolPhasesofaStudyEthicsProtectionofPartic

2、ipantsContributionsofClinicalTrialsParticipatinginaTrialConclusion&TakeHomeMessageNY/VIAETCOverviewtoResearchStudiesWhyDoResearchStudies?Tocollectdataonusualandunusualevents,conditions,&populationgroupsTotesthypothesesformulatedfromobservationsand/orintuition

3、Ultimately,tounderstandbetterone’sworldandmake“senseofit”NY/VIAETCOverviewtoResearchStudiesVarioustypesofresearchstudiesManyclassifiedas“EpidemiologicalStudies”Epidemiologyoftenisdefinedas:Thestudyofthedistributionofadiseaseorconditioninapopulationandthefacto

4、rsthatinfluencethatdistribution.NY/VIAETCClassificationsofResearchStudies:ThreeMainTypesObservationalStudies:Groupsarestudied&contrastsmadebetweengroupsTheobserveddatacollectedareanalyzedAnalyticStudies:AlsocalledExperimentalStudytheimpactofacertaintherapyUlt

5、imatelytheinvestigatorcontrolsfactorbeingstudiedClinicalTrial:Consideredthe“true”experimentalstudy“GoldStandard”ofclinicalresearchOftenaprospectivestudythatcomparestheeffectandvalueofaninterventionagainstacontrolinhumansubjectsNY/VIAETCAnotherClassificationSy

6、stemNon-directedDataCaptureEx:VitalStatisticsDirectedDataCapture&HypothesisTestingEx:CohortStudies,CaseControlStudiesClinicalTrialsEx:InvestigationofTreatment/ConditionEx:DrugTrialsNY/VIAETCTheDifferentStudyDesignsCase-control•CohortCaseReports•CaseSeriesOutc

7、omesBased:•SurveyResearch:QualityofLifeQuestionnairesDecisionanalysisPollsEconomicAnalysisSurveysMetaAnalysesSurvivalAnalysisRandomizedClinicalTrialNY/VIAETCBasicResearchTerminologyRetrospective:ReferstotimeofdatacollectionProspective:Referstotimeofdatacollec

8、tionCaseControlStudy:Personsw/disease&thosew/outarecomparedCohortStudy:Personsw/and/orw/outdiseasearefollowedovertimeNY/VIAETCTerminology(Cont.)Cross-sectionalStudy:Presenceorabsenceofexp