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clinicaltrials临床试验方案
Overview
PurposeofResearchStudies
ClassificationsofEpidemiologicalResearch
BasicResearchTerminology
FeaturesofClinicalTrials
Design/Protocol
PhasesofaStudy
Ethics
ProtectionofParticipants
ContributionsofClinicalTrials
ParticipatinginaTrial
Conclusion&TakeHomeMessage
clinicaltrials临床试验方案
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OverviewPurposeofResearch
OverviewtoResearchStudies
WhyDoResearchStudies?
Tocollectdataonusualandunusualevents,conditions,&populationgroups
Totesthypothesesformulatedfromobservationsand/orintuition
Ultimately,tounderstandbetterone’sworldandmake“senseofit”
clinicaltrials临床试验方案
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OverviewtoResearchStudiesWh
OverviewtoResearchStudies
Varioustypesofresearchstudies
Manyclassifiedas“EpidemiologicalStudies”
Epidemiologyoftenisdefinedas:
Thestudyofthedistributionofadiseaseor
conditioninapopulationandthefactorsthat
influencethatdistribution.
clinicaltrials临床试验方案
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OverviewtoResearchStudiesVa
ClassificationsofResearchStudies:ThreeMainTypes
ObservationalStudies:
Groupsarestudied&contrastsmadebetweengroups
Theobserveddatacollectedareanalyzed
AnalyticStudies:
AlsocalledExperimental
Studytheimpactofacertaintherapy
Ultimatelytheinvestigatorcontrolsfactorbeingstudied
ClinicalTrial:
Consideredthe“true”experimentalstudy
“GoldStandard”ofclinicalresearch
Oftenaprospectivestudythatcomparestheeffectandvalueofaninterventionagainstacontrolinhumansubjects
clinicaltrials临床试验方案
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ClassificationsofResearchSt
AnotherClassificationSystem
Non-directedDataCapture
Ex:VitalStatistics
DirectedDataCapture&HypothesisTesting
Ex:CohortStudies,CaseControlStudies
ClinicalTrials
Ex:InvestigationofTreatment/Condition
Ex:DrugTrials
clinicaltrials临床试验方案
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AnotherClassificationSystem
TheDifferentStudyDesigns
Case-control •Cohort
CaseReports •CaseSeries
OutcomesBased: •SurveyResearch:
QualityofLife Questionnaires
Decisionanalysis Polls
EconomicAnalysis Surveys
MetaAnalyses
SurvivalAnalysis
RandomizedClinicalTrial
clinicaltrials临床试验方案
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TheDifferentStudyDesignsCas
BasicResearchTerminology
Retrospective:Referstotimeofdatacollection
Prospective:Referstotimeofdatacollection
CaseControlStudy:Personsw/disease&thosew/outarecompared
CohortStudy:Personsw/and/orw/outdiseasearefollowedovertime
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BasicResearchTerminologyRetr
Terminology(Cont.)
Cross-sectionalStudy:.
Prevalence:The#ofnewcasesandexistingcasesduringspecifiedtimeperiod.
Incidence:The#ofNEWcasesperunitofapopulationatriskfordiseaseoccurringduringstatedtimeperiod.
clinicaltrials临床试验方案
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Terminology(Cont.)Cross-secti
HistoricalMinute First“ClinicalTrials”
ClinicalTrialshavealonghistory–evenifnotacknowledgedasClinicaltrials
Formalrecordofclinicaltrialsdatesbacktothetimeofthe“Trialists”:
’sproposalforatherapeutictrialofbloodlettingforfevers[1628]
’s,ashipsurgeon,trialoforanges&limesforscurvy[1747]
clinicaltrials临床试验方案
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HistoricalMinute First“Clini