文档介绍：NY/VIAETCUnderstanding ClinicalTrialsDevelopedbySaraBack,NPBronx-LebanonHospitalCenterNY/VIAETCOverviewPurposeofResearchStudiesClassificationsofEpidemiologicalResearchBasicResearchTerminologyFeaturesofClinicalTrialsDesign/ProtocolPhasesofaStudyEthicsProtectionofParticipantsContributionsofClinicalTrialsParticipatinginaTrialConclusion&TakeHomeMessageNY/VIAETCOverviewtoResearchStudiesWhyDoResearchStudies?Tocollectdataonusualandunusualevents,conditions,&populationgroupsTotesthypothesesformulatedfromobservationsand/orintuitionUltimately,tounderstandbetterone’sworldandmake“senseofit”NY/VIAETCOverviewtoResearchStudiesVarioustypesofresearchstudiesManyclassifiedas“EpidemiologicalStudies”Epidemiologyoftenisdefinedas::ThreeMainTypesObservationalStudies:Groupsarestudied&contrastsmadebetweengroupsTheobserveddatacollectedareanalyzedAnalyticStudies:AlsocalledExperimentalStudytheimpactofacertaintherapyUltimatelytheinvestigatorcontrolsfactorbeingstudiedClinicalTrial:Consideredthe“true”experimentalstudy“GoldStandard”parestheeffectandvalueofaninterventionagainstacontrolinhumansubjectsNY/VIAETCAnotherClassificationSystemNon-directedDataCaptureEx:VitalStatisticsDirectedDataCapture&HypothesisTestingEx:CohortStudies,CaseControlStudiesClinicalTrialsEx:InvestigationofTreatment/ConditionEx:DrugTrialsNY/VIAETCTheDifferentStudyDesignsCase-control •CohortCaseReports •esBased: •SurveyResearch:QualityofLife QuestionnairesDecisionanalysis PollsEconomicAnalysis SurveysMetaAnalysesSurvivalAnalysisRandomizedClinicalTrialNY/VIAETCBasicResearchTerminologyRetrospective:ReferstotimeofdatacollectionProspective:ReferstotimeofdatacollectionCaseControlStudy:Personsw/disease&thosew/paredCohortStudy:Personsw/and/orw/outdiseasearefollowedovertimeNY/VIAETCTerminology(Cont.)Cross-sectionalStudy: