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Understanding
ClinicalTrialsDevelopedbySaraBack,NPBronx-LebanonHospitalCenterOverview
Purposeof
ResearchStudiesClassificationsofEpidemiologicalResearchBasicResearchTerminologyFeaturesofClinicalTrialsDesign/ProtocolPhasesofaStudyEthicsProtectionofParticipantsContributionsofClinicalTrialsParticipatinginaTrialConclusion&TakeHomeMessageOverviewtoResearchStudiesWhyDoResearchStudies?Tocollectdataonusualandunusualevents,conditions,&populationgroupsTotesthypothesesformulatedfromobservationsand/orintuitionUltimately,tounderstandbetterone’sworldandmake“senseofit”O(jiān)verviewtoResearchStudiesVarioustypesofresearchstudiesManyclassifiedas“EpidemiologicalStudies”Epidemiologyoftenisdefinedas:Thestudyofthedistributionofadiseaseorconditioninapopulationandthefactorsthatinfluencethatdistribution.ClassificationsofResearchStudies:ThreeMainTypesObservationalStudies:Groupsarestudied&contrastsmadebetweengroupsTheobserveddatacollectedareanalyzedAnalyticStudies:
AlsocalledExperimentalStudytheimpactofacertaintherapyUltimatelytheinvestigatorcontrolsfactorbeingstudiedClinicalTrial:Consideredthe“true”experimentalstudy“GoldStandard”ofclinicalresearchOftenaprospectivestudythatcomparestheeffectandvalueofaninterventionagainstacontrolinhumansubjects AnotherClassificationSystem
Non-directedDataCapture
Ex:VitalStatisticsDirectedDataCapture&HypothesisTesting
Ex:CohortStudies,CaseControlStudiesClinicalTrials
Ex:InvestigationofTreatment/ConditionEx:DrugTrialsTheDifferentStudyDesignsCase-control ?CohortCaseReports ?CaseSeriesOutcomesBased: ?SurveyResearch:QualityofLife QuestionnairesDecisionanalysis PollsEconomicAnalysis SurveysMetaAnalysesSurvivalAnalysisRandomizedClinicalTrialBasicResearchTerminologyRetrospective:
ReferstotimeofdatacollectionProspective:
ReferstotimeofdatacollectionCaseControlStudy:
Personsw/disease&thosew/outarecomparedCohortStudy:
Personsw/and/orw/outdiseasearefollowedovertimeTerminology(Cont.)Cross-sectionalStudy:Presenceorabsenceofexposuretopossibleriskfactormeasuredatonepointintime.Prevalenceobtained.Prevalence:The#ofnewcasesandexistingcasesduringspecifiedtimeperiod.Incidence:The#ofNEWcasesperunitofapopulationatriskfordiseaseoccurringduringstatedtimeperiod.HistoricalMinute
First“ClinicalTrials”ClinicalTrialshavealonghistory–evenifnotacknowledgedasClinicaltrialsFormalrecordofclinicaltrialsdatesbacktothetimeofthe“Trialists”:Dr.VanHelmont’sproposalforatherapeutictrialofbloodlettingforfevers[1628]Dr.Lind’s,ashipsurgeon,trialoforanges&limesforscurvy[1747]HistoricalMinute
First“ClinicalTrials”HistoricalHighlightsofDrugTrials1909:
PaulEhrlich-Arsphenamine1929:
AlexanderFleming-Penicillin1935:GerhardDomagk-Sulfonamide1944:Schatz/Bugie/Waksman–StreptomycinBy1950,theBritishMedicalRes.Councildevelopedasystematicmethodologyforstudying&evaluatingtherapeuticinterventionsCoreComponentsofClinicalTrialsInvolvehumansubjectsMoveforwardintimeMosthaveacomparisonCONTROLgroupMusthavemethodtomeasureinterventionFocusonunknowns:effectofmedicationMustbedonebeforemedicationispartofstandardofcareConductedearlyinthedevelopmentoftherapiesCoreComponentsofClinicalTrialsMustreviewexistingscientificdata&buildonthatknowledgeTestacertainhypothesisStudyprotocolmustbebuiltonsoundðicalscienceControlforanypotentialbiasesMoststudymedications,procedures,and/orotherinterventionsThePossibleWorldofClinicalTrialDesignsRandomized/blindedtrialRandomized/doubleblindedtrialNon-randomizedconcurrentcontrolledtrialPlacebotrialHistoricalcontrolledtrialCrossoverTrialWithdrawaltrialSimplifiedRandomized:SchemesusedtoassignparticipanttoonegroupEx:Every3getshigherdoseNonrandomized:AllwithHep.C=cases;others=controlsProtocol:Studydesign-instructionsBlinded:ParticipantsdonotknowifinexperimentalorcontrolgroupDoubleBlinded:ParticipantsANDstaffdonotknowgroupassignmentPlacebo:Inactivepillw/notherapeuticvalueComponentsofClinicalTrialProtocolsInvestigatingtwoormoreconditionssohavetwo(+)groupsEx:drugvs.placebo;medicinevs.surgery;lowdosevs.highdoseSpecificinclusion/exclusioncriteriaSamplesize&powercalculationsPlanre:potentialbiasesPlanre:handlingofattrition/losstofollowupStudyParticipantRecruitmentIdentifyeligibleparticipantsExplainstudyProvideinformedconsentReassesseligibilityAssigntoonegroupParticipantsshouldbetold:Mayhavesideeffects(adverseeffects)TimecommitmentBenefits&risksMaywithdrawatanytimeEnrollment100%voluntaryPhasesofClinicalTrialsMosttrialsthatinvolvenewdrugsgothroughaseriesofsteps:#1:Experimentsinthelaboratory#2:Oncedeemedsafe,gothrough1-4phasesPhasesofClinicalTrialsPhaseI:Smallgroup[20-80]for1sttimetoevaluatesafety,determinesafedosagerange&identifySEPhaseII:
Rx/txgiventolargergroup[100-300]toconfirmeffectiveness,monitorSE,&furtherevaluatesafetyPhasesofClinicalTrials(cont.)PhaseIII:
Rx/txgiventoevenlargergroup[1,000-3,000]tofulfillallofPhaseIIobjectives&compareittoothercommonlyusedtxs&collectdatathatwillallowittobeusedsafelyPhaseIV:
Doneafterrx/txhasbeenmarketed-studiescontinuetotestrx/txtocollectdataabouteffectsinvariouspopulations&SEfromlongtermuse.SummaryofPhasesI-III#Subs.LengthPurpose%DrugsSuccessfullyTestedPhaseI20–100SeveralmonthsMainlySafety70%PhaseIIUptoseveral100Severalmonths-2yrs.Shorttermsafety;mainlyeffectiveness33%PhaseIII100s–several10001-4yrs.Safety,dosage&effectiveness25-30%EthicsofClinicalTrials:
ProtectionofParticipants3ethicalprinciplesguideclinicalresearch:RespectforPersons:TreatmentofpersonasautonomousBeneficence:Issuere:potentialconflictbetweengoodofsocietyvs.individualJustice:Treatmentofallfairly&allequallysharebenefits&risksEthicalNormsofClinicalTrialsSoundstudydesignstakeintoaccount:RandomizationorsharingofrisksProperuseofplaceboProcessestomonitorsafetyofrx/txCompetentinvestigatorsInformedconsentEquitableselectionofparticipantsCompensationforstudyrelatedinjuriesEthicalIssues:
ProtectionofHumanSubjectsRelyonintegrityofInvestigatorbutoutsidegroupsalsohaveoversightParticipants’rightsprotectedbyInstitutionalReviewBoards[IRBs]AnIRBisdefinedas:"anyboard,committeeorothergroupformallydesignatedbyaninstitutiontoreview,toapprovetheinitiationof,andtoconductperiodicreviewofbiomedicalresearchinvolvinghumansubjects"HumanSubjects’ProtectionIRBresponsibleforsuchtasks:ReviewresearchtoensurethatpotentialbenefitsoutweighrisksDevelopandissuewrittenproceduresReviewresearchforrisk/benefitanalysis&properprotectionofsubjectsIssuewrittennoticeofapproval/disapprovaltotheInvestigatorReviewandrespondtoproposedprotocolchangessubmittedbytheInvestigatorHumanSubjects’ProtectionReviewreportsofdeaths,andseriousandunexpectedadverseeventsreceivedfromtheInvestigatorConductperiodiccontinuingreviewofthestudy,studyrisks,selectionofsubjects,privacyofsubjects,confidentialityofdata,andtheconsentprocessIRBResponsibilities(continued):HistoricalMinute:
OriginofIRBs&HumanSubjectCodeAttentiontoprotectingparticipantsbeganafterWWIIw/theNurembergTrials(1947)Outofthosetrials,keypointswerecodifiedHistoricalMinute:
10KeyPointsVoluntaryinformedconsentExperimentmustbeforthegoodofsociety,&resultsnotobtainablebyothermeansExperimentshouldbebaseduponprioranimalstudiesPhysical&mentalsuffering&injuryshouldbeavoidedNoexpectationthatdeath/disablinginjurywilloccurfromtheexperimentRiskvs.benefitProtectsubjectsagainstinjury,disability,ordeathOnlyscientificallyqualifiedpersonstobeinvolvedSubjectcanterminateher/hisinvolvementHistoricalMinute:
OriginofIRBs&HumanSubjectCodesSince1947,additionalsubjectprotectionrequirementsdeveloped&implementedLatestadditions:Year2023-PresidentClinton&DHHSSecretaryShalalaannouncedadditionalstudyrequirementsrelatedto:informedconsent trainingreq. adverseeventsconflictofinterest civilmonetarypenaltiesimprovedmonitoringofPhaseI&IItrialsInformedConsent:
APartofHumanSubjectProtectionObjectivesofInformedConsentToEnsure:VoluntarinessComprehensionInformationToDemonstrateThat:PersonfreelygaveconsenttoparticipateConsentgivenbyacompetentpersonPersonhasbeengivenallinformationPersonknowsthisisresearch–nottreatmentComponentsofInformedConsentMustIncludetheFollowingInformation:Whyresearchbeingdone?WhatresearcherswanttoaccomplishWhatwillbedoneandforhowlongRisks&benefitsoftrialOthertreatmentsavailableCanwithdrawfromtrialwheneverdesireCompensationforunexpectedinjuriesVulnerablePopulationsGroupsthoughtnottohaveautonomytogiveinformedconsent:childrenmentallyimpaired,individualswithdementiaPrisonersORWhomaybeundulyinfluencedtoparticipate:studentssubordinatespregnantwomen(actually,thefetuses)patients(care-givervs.researcher)VulnerablePopulationsTosafeguardthesegroups,specialrequirementssuchas:OnlyparentcanconsentforminorConsentsmustbeinsubject’snativelang.Prisoners:onlysometypesofresearchallowedInclusioninClinicalTrialsNIHRevitalizationActof1993:Guidelinesthatrequireinclusionofwomen&minoritiesinclinicalstudiesNewguidelinesstipulatethat:Women&minoritiesaretobeincludedinallhumansubjectresearchTheyaretobeincludedinPhaseIIItrialstoallowsufficientpowertonotedifferencesCostcannotbeabarrierOutreachactivitiesmusttakeplacetoinclude&followthesegroupsInclusioninClinicalTrialsHistoricallywomenwereexcludedifofreproductiveage(ages18-45)FearofharmtopotentialunbornchildInessence,excludedMAJORITYofwomenNewguidelineseliminatesthisstipulationIssuesinClinicalTrials:
UseofPlaceboTrialsOninternationalrealm,1999“DeclarationofHelsinki”revisedtoaddressuseofplacebos:PlacebosnotethicalinvirtuallyallstudiesthatinvolvediseaseswithPROVENtxRemainethicalintrialswherenoproventxRevisionsduetocontroversyoveruseofplacebosinattemptingtofindeasy/cheapwaytoreduceHIVperinataltransmission
1998studyinIvoryCoast,Uganda,&Thailand:HIV+pregnantwomengiveneitherplaceboorshortercourseofAZT
ParticipationinClinicalTrialsWhySomeParticipate:GivebacktosocietyExhaustedallothertxsHealthcareservicesPayment&incentivesSupportOthers??WhySomeDoNot?MistrustofstudiesDonotwanttobe“guineapig”
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