艾昆玮-利用真实世界的证据支持肿瘤靶向治疗（英）.pdf

WhitePaperLeveragingRealWorldEvidencetoSupportOncologyTargetedTherapiesTableofcontentsExecutivesummary3Introduction:RealWorldEvidence(RWE)forprecisiononcology4Challenge:RWEwithnovelbiomarkers5Solution1:Accesstolinkedbiomarker&clinicaldata6Solution2:Retrospectivetestingofarchivaltissues7Solution3:EnablingAI-Poweredprecisiononcology8Conclusion9Abouttheauthor9References10iqvia.com|3OurwhitepaperprovidesanoverviewofacomprehensivesolutionforgeneratingRealWorldEvidence(RWE)inthefieldofprecisiononcology.OncologytargetedtherapiescansignificantlybenefitfromRWEprograms,speedingupclinicaldevelopment,supportingmarketaccess,anddrivingmarketpenetration.However,theadoptionofnovelbiomarkersinclinicalpracticeisslow.This,combinedwiththevariabilityintestingpracticesandthelowprevalenceofsomenovelbiomarkers,makesRWEprogramsunpredictable,costlyandevenunfeasibleincertaincases.OurteamhasdevelopedacomprehensivesolutiontoincreasethefeasibilityandmaximizethevalueofRWEprogramsfortargetedcancertherapies,including:•Accesstolinkedbiomarker&clinicaldata:BypartneringwithleadingoncologycentersinEurope,thissolutioncombinesrichbiomarkerdatawithclinicalElectronicMedicalRecord(EMR)data.ItenablesvarioustypesofRWEstudiesandenhancesefficientsiteselection,expeditingevidencegenerationandmarketaccess.•Retrospectivetestingofarchivaltissues:Collaborationwithbiobanksandpathologylabsallowsforretrospectivetestingofarchivaltissuesamples,broadeningourunderstandingofnovelandunder-testedbiomarkers.Thisefficientandcost-effectiveapproachspeedsupprecisiononcologystudies.•EnablingAI-Poweredprecisiononcology:Thissolutionstreamlinesaccesstoimagingandpathologydataforpharmaceuticalpartners.Whetherfordetectingoncologybiomarkersfrompathologyimagesordiscoveringradiomics-basedbiomarkers,thesedatamodalitiesarekeyforleveragingmachine-learningtechnologies.OurdedicatedsolutionenablesustoruneffectiveRWEprogramsfortargetedcancertherapies,evenfornovelandunder-testedbiomarkers,andhelpsourpharmaceuticalpartnersgetthemostvaluefromtheseprograms.ExecutivesummaryIQVIA"sOncologyEvidenceNetwork(OEN)collaborateswithacademichospitalsandcancercenterstoproducesignificantreal-worldevidencestudiesinoncology.Withmorethan30partners,OENhasenabledmanyRWEstudiesacrossabroadrangeofoncologyindications,includingnaturalhistory,comparativeeffectiveness,externalcomparator,andprecisiononcologystudies.4|LeveragingRealWorldEvidencetoSupportOncologyTargetedTherapiesIntroduction:RealWorldEvidence(RWE)forprecisiononcologyTargetedtherapiesareinstrumentalinrevolutionizingcancertreatment,astheyprovidepersonalizedcaretoeachpatient.Productsthatnecessitatebiomarkertestingaccountforapproximately60%oftheoncologymarketshare1.Remarkably,thissegmentisexperiencingthehighestgrowthratewithinoncology,boastingarobustcompoundannualgrowthrate(CAGR)of21%1.Anexaminationoftheoncologypipelinesuggeststhatthistrendisexpectedtopersistinthefuture.Thesetargetedtherapiesinherentlyfaceauniquesetofchallengeswhenitcomestogeneratingclinicalevidenceandmarketentry.ThisiswhereRealW