艾昆玮-在以患者为中心的时代赋予临床研究机构和赞助商权力（英）.pdf

WhitePaperEmpoweringClinicalResearchSitesandSponsorsinthePatient-centricEraKERRYGORMAN,SeniorDirector,StrategicSiteSolutionsCOLLEENGOSA,RNPSSolutionsDirector,DecentralizedTrialsKYLIESCHEIDELER,HeadofOptimizationStrategies,AvacareKATYPRECIADO,DirectorofDCTStrategyREBECCASAYERS,HeadofSiteSupportTableofcontentsIntroduction2Patient-centricmustfirstbesite-centric2Solvingsitedecentralizedchallenges3Solvingsitestaffingandretention5Casestudy:Clinicaltrialcomplexity7Decentralizationandmoredata7Retainingtalentandstaffing7Technologyandtraining7Patientrecruitment&enrollment8Attractingpatients&improvingdiversity9Conclusion:sitesmatter10AboutIQVIA11References12iqvia.com|2Initstransformativerole,strategicsitecollaborationcanfosterpatient-centricitybyrecognizingchallengesfacedbyclinicaltrialsitesandredefiningthesiteasthehubofpatient-centrictrials.Withcollaborationinsteadofdelegation,sponsorscandecreasesitechallengesandmaintainpatientengagementastheindustrycontinuestoshifttowardamorepatient-centricmodel.Clinicaltrialsareneeded,butdobiopharmaceuticalsponsors,researchsitesandpatientsallwantthesamething?Yes,todeliverbetterhumanhealthbybringingnewmedicinestomarket—butthat’stheshortanswer.Sometimes,clinicaltrialsitessay“no”toparticipatinginastudyforreasonsbeyondenrollmentorrecruitment.Forsites,technologyandtrainingcanbeburdensome.Trialadministrationiscomplicated.Staffinglevelsaren’tadequate.Timelinesdon’talign.Endpointsarecomplex.Diseasesarerare.Patientsaregeographicallyisolated.Therearesomanychallengesitisn’teasytodecidewhichtofocuson.TherapidadoptionofDecentralizedClinicalTrialapproaches(DCTs)hashelpedtowidenpatientaccess,increaseparticipantdiversityandreduceoverallpatientburden.Yet,mostclinicaltrialstaffarenowgivenmultiplenewactivitiesinadditiontotheirstandardpractices—alongwitheverysponsor’snewtechnology,newtrainingandnewprocesses.Thus,sitepersonnelfeelburdenedtokeepupandDCTapproachesmayonlybecomplicatingthings.Asbothpatientsandsitestaffreportapreferenceforhybrid-designedclinicaltrials1,theroleofthesitebecomesevenmorecritical.Today’sclinicaltrialrealitiesdictatethatresearchsitesmustfindtherightnumberandrightmixofpatientsattherighttime,continuetosupportthemthroughout—anddosoontime,onbudgetandinawaythatenhancesthepatientexperienceandproduceshigh-qualitydata.It’sacomplexprocessandmanysitesareconcerneditwillbecomeevenmoreburdensomewithoutaseatatthetable.Thekeytakeawayisthattrialsitesdon’twanttoperformpoorlybecauseitimpactstheirbottomline.Nevertheless,sites,sponsors,andpatientscanovercomeobstaclestosuccessfulperformancebymakingtrialsitesthecornerstoneofpatientcentricity.Throughempoweredrelationships,insights,data,andtechnology,sponsorsandsitescanprovidethebestexperienceforthepatient,on-siteorremote.Patient-centricmustfirstbesite-centricSponsorsmustbemindfulthatresearchcannotbepatient-centricwithoutfirstbecomingsite-centric.Supportalongthejourneytosuccessfulpatient-centricitymustreducetheadministrativeburdenofsites’day-to-daytrialmanagementandpatientserviceexecutionaswe