Investigator Responsibilities in Clinical Research.ppt

investigatorresponsibilitiesinclinicalresearch,melissaaddedirector,clinicaltrialsoffice,inctr,,topicstobediscussed,overviewofclinicaltrialsgoodclinicalpracticethe“researchteam”theroleandresponsibilitiesoftheprincipalinvestigator,overviewofclinicaltrials,definitionresearchstudiesinvolvingpatientsorpopulationsatriskfordiseasemaybedirectedatquestionsofcausation,prevention,earlydetectionortreatmentdesignedinascientificmannerandconformtoethicalstandards,importanceofclinicaltrials,toincreaseknowledgetoprovide“evidence-based”patientcareorpreventionofdiseasetoimprovethequalityofcarepatientsparticipatinginatrialtendtoreceivebettercarequalityofcareforotherpatientswhoarenotparticipatinginatrialcanalsobeimproved(i.e.,supportivecare),whytheemphasisonevidence?,toreversethefollowingproblems:assumptionsthatarenotbaseduponfactscontinuetobemadedoctorsworklargelyindependentlywithoutincentivestoupdatetheirknowledgeoften“behindthetimes”traditionalorprofessorsapproachesgenerallyusedmaybeineffective“eminencebased”medicine,whoconductsclinicaltrials?,academiccentersgroupsofacademiccenterscooperativegroupsgovernmentagenciesorinstitutionscorporations(pharmaceuticalcompanies,biotechnologycompanies)usuallydoneviaacademicorprivateinstitutions,theconductofclinicaltrials,frameahypothesisbaseduponpresentknowledgeisthestudyquestionimportantandrelevant?designastudytotestthehypothesiswriteadetailedplanofthestudy(protocol)obtainethicalreviewandapprovalconductstudy,adheringcloselytotheprotocolcollectrelevant,pre-determineddataelementsensurethatthedataisofthehighestqualitypossibleanalyzethedataanddrawconclusions,theprotocoldocument,detailedplanandinstructionsfortheconductofthetrialguidebookforthoseinvolvedintheday-to-daycareofthepatientenrolledonthetrial,elementsoftheprotocoldocument,titlepageobjectives(primaryandsecondary)backgroundandrationaleeligibilitycriteria(inclusionandexclusioncriteria)evaluationparametersbaselineandthosethatsupportandconfirmeligibilitytreatmentplanmodificationssupportivecareconcurrenttherapies(includingcontraindications),elementsoftheprotocoldocument,treatmentplan(cont)surgicalguidelinesradiationtherapyguidelinesoff-studycriteriapost-studyevaluation(whattestsshouldbedoneandhowoften)datacollectionandreportingproceduresstatisticalsectionsamplesize,studyduration,relevantendpoints,elementsoftheprotocoldocument,statisticalsectionhowendpointswillbeevaluated(e.g.,response,adverseevents)multi-institutionalguidelines(ifapplicable),elementsoftheprotocoldocument,ethicalconsiderationsdiscussionofrationaleforrisksarerisksreasonableinrelationtotheanticipatedbenefits?arerisksreasonableinrelationtotheimportanceoftheknowledgetobegained?,elementsoftheprotocoldocument,ethicalconsiderations(cont)informedconsentproceduresconflictsofinterestpharmaceuticalsectioninformationaboutthestudydrug(s)publicationpolicywhowillbeinvolved,registrationofthetrialreferences,goodclinicalpractice(gcp),internationalandscientificqualitystandardfor:designingconductingrecordingreportingtrialsthatinvolvetheparticipationofhumansubjects,compliancewithgcp,providespublicassurancethatthe:rights,safetyandwell-beingareprotectedandconsistentwiththedeclarationofhelsinkiensuresthatclinicaltrialdataandreportedresultsare:accuratecredible,dowereallyneedgcp?,whyweneedgcp,internationalconcernfortheprotectionofhumansubjectsinvolvedinresearchhasincreasedhistoricalinfluences(wwii,vulnerablepopulations)needforresearchtoadvancemedicalknowledgeunifiedtofacilitatemutualacceptanceofclinicaldatabyregulatoryauthorities,theresearchteam,definitionagroupofpeopleworkingtogetherinasystematicandscientificmannertoestablishfactscommittedtoapplyingtheprinciplesofgcpintheconductofclinicalresearchthatmayhaveanimpactonthesafetyandwell-beingofhumansubjects,membersoftheresearchteam,principalinvestigatorco-investigatorsorassociateinvestigatorsclinicalresearchcoordinatordatamanagerclinicalpharmaciststatistician,membersoftheresearchteam,patient(s)institutionalreviewboard(irb)regulatorybodies,theprincipalinvestigator,theindividualwhoactuallyconductstheclinicaltrialorresearchstudy(usuallyreferredtoasthepi)theleaderoftheresearchteamatthesite,qualificationsofthepi,anappropriatelyqualifiedpersonintherelevantfieldofhealthcare(md,phd,pharmd,nurse)trainedandexperiencedinclinicalresearchfamiliarwiththestudybackgroundandrequirements,responsibilitiesofthepi,familiarwiththebackgroundofthestudy(e.g.,disease,managementofthedisease,sideeffectsoftreatment)familiarwiththestudytheprotocoldocumentandstudyproceduresrememberreadingisfundamentalifyouwanttobeaneffectivepi,somethingstothinkabout,howmanyerrorscouldbeavoidedbytakingthetimetoreadtheprotocol?ifshort-cutsinreadingtheprotocol(schemaonly)aretakenareyoupreparedtoconducttheprotocol?willyoubeeffectiveasaleader?dontsetabadexample!whatifyouoryourinstitutionisunabletocarryoutsomeprotocolrelatedproceduresortests?shouldyouagreetoparticipate?,responsibilitiesofthepi,obtainirbapprovaloftheprotocolandinformedconsentpriortotheinitiationofthestudy(i.e.,patientenrollment)befamiliarwithanynationallawsthatmayimpactthestudydesignorparticipationdrugapprovalimportationofdrugs(where,how,costs)humantissues(storage,use,transfertoanotherinstitutionorothercountry)fundingpoliciesorrules,responsibilitiesofthepi,obtaininformedconsentfrompatientsorparentsofminorpatientspriortostartingprotocoltreatmentpriortorandomizingpatientsifthestudyisarandomizedtrial,informedconsent,informedconsentisa“process”itdoesnotendwiththesignatureofthepatientonapieceofpaperon-goingandinteractiveprocessbetweentheresearchteamandthepatienttoensurepatientunderstandsthestudytoensurepatientunderstandswhatisrequiredtoparticipateinthestudy,informedconsentpiresponsibilities,providethenecessaryinformationtothepatientorparentofaminorchildaboutthestudyobtaintheinformedconsent(documentationthattheprocesstookplace)may“delegate”toothermembersoftheresearchteamiftheyareknowledgeableabouttheinformedconsentprocess,informedconsentinformationtobeconveyed,participationisvoluntaryinformationaboutthepatientsdiseaserationaleforspecifictherapyplannedinthetrialdescriptionofthe“research”objectivesdifferentiationbetween“research”elementsand“standardcare”,informedconsentinformationtobeconveyed,patients“requiredinvolvement”durationofparticipationfrequencyofhospitalizations,outpatientvisitsduringtreatmentfrequencyofvisitsaftertreatmentalternativeapproachestotreatmentstandardtreatmentnotreatmentifnoalternativesexistrisksordiscomforts(sideeffectsoftreatmentandprocedures),informedconsentinformationtobeconveyed,statehowpatientsconfidentialitywillbemaintainedprovisionsforresearch-relatedinjuriesandcompensationfordisabilityordeathcoststothepatientasaresultofparticipationcontactdetailsforproblemsorquestionspipatientadvocate,responsibilitiesofthepi,enrollonlyeligiblepatientsobserve,evaluate,manageanddocumentalleffectsoftreatmentresponseotherstudyend-pointsadverseeventsdeathsreportadverseeventsanddeathsasspecifiedwithintheprotocolirbsponsor(ifstudysponsored),responsibilitiesofthepi,notifyirband/orsponsorofanyissuesthatposeathreattothesafetyandwell-beingofthepatientsinthestudysubmitanychanges(amendments)madetotheprotocoltotheirbforapprovalprovideinformationaboutprotocolprogresstotheirbonanannualbasis(annualcontinuingreviews),responsibilitiesofthepi,recordalldatapertinenttothestudymaintainallstudydocumentationperformdataverificationmatchcasereportformswithsourcedatamakedataavailableforexternalmonitors(ifapplicable),responsibilitiesofthepi,complywithallproceduresspecifiedintheprotocolinaccordancewithgcp,responsibilitiesofthepi,maydelegateresponsibilitiestoothermemberso