艾昆緯-eCOA技術(shù)指南 eCOA Technology Guide Seven recommendations to consider when vetting eCOA technology solutions

WHITEPAPERSevenrecommendationstoconsiderwhenvettingAtechnologysolutionsJ.C.WILSON,SeniorDirector,PatientCenteredTechnologiesProduct&Engineering,IQVIAPlanningyourplatformWhensponsorsandsitesinitiallyembracedecentralizedclinicaltrial(DCT)models,electronicclinicaloutcomeassessments(eCOAs)areamongthefirsttoolstheyadopt.Theseplatformsintelligentlyautomatecollectionofthepatient’sexperiencesthroughrobustandreliableelectronicmeasures,providingreal-timequantitativeandqualitativeinsightsthatinformtrialprogressanddemonstrateresults.eCOAsalsomakeiteasierforpatientsandcaregiverstoshareinformationinreal-timeaboutthetreatmentexperiencewithouttheaddedburdenofconstantsitevisits.But,aswithanytechnologyusedinclinicalresearch,choosingtherightvendor,solutionanddeploymentmodelarecriticalforsuccess.eCOAsmayseemlikesimpleenoughtoolstodeployinatrialsetting,butthisisn’taonesizefitsallsolutionthatcanberolledoutthedayatrialgoeslive.Everyapplicationmustbecustomizedtotheneedsofthesponsors,thesitestaffandthepatients,withfeaturesandoptionsdesignedtoensuredatacanbesecurelycollectedandreviewedwithminimaldisruptiontousers.omizedtotheneedsofthesponsors,thesitestaffandthepatients,featuresandoptionsdesignedtoensuredatacanbesecurelycollectedmaldisruptiontousers.Becausethistechnologyisstillrelativelynovel,manysponsorsaren’tcertainwhattheyneedtolookforinaneCOAplatform,howtoalignfeatureswiththeneedsofthestudy,andwhattraining,supportandreviewstepsarerequiredtocreateaseamlessuserexperience.Withoutproperplanningandtherightvendor,it’seasytomakechoicesthatleadtounexpectedstart-updelays,disgruntledpatients,frustratedstaffandalotofhiddencoststhatcouldhavebeen/ecoa1SIMPLIFYWORKFORSITESTAFFSitestaffneedsalsoneedtobeconsideredwhenvettingeCOAtechnology.Sitestaffwillbeexpectedtoconstantlyreviewassessmentresults,verifycompletionrates,andtransferdatatostudydatabases.Thisistimetheyspendawayfrompatients,sothetechnologyhastobesimpleandeasytoaccesswithfewbarriers.Ideally,aninvestigatorwillbeabletodropintotheplatform,lookatthedata,makedecisionsandgetoutwithinminutes.ThebesteCOAplatformsaredefinedbyhowlittlesitestaffmustinteractwiththem.So,whenvettingwhetheraneCOAplatformisrightforsitestaff,decision-makersshouldfocusonthespeedandsimplicityofworkflows.Howmuchtimedoesittaketocreateanewpatientprofile?Howeasyisittomonitorthestatusofindividualsorgroupsofpatientsinthestudy?Caninvestigatorsseecomplianceratesataglance,ordotheyneedtodig10layersdeeptofindthatinformation?Thegoalshouldbefortheinvestigatorandsiteteamtospendaslittletimeaspossiblelearningtousetheplatformandinteractingwithitintheirday-to-daywork.Remember,theirjobisnottospendtimeinyourdataecosystem.Theirjobistotreatpatientsandworktheirwaythroughtheprotocol.PROTECTTHEDATADatadoesnotspenditsentirelifeonaneCOAplatform.Ratheritisastartingpointforthedataiscapturedandsenttoanotherdatabasewhereitcanbeanalyzedandpreparedforregulatoryreview.WhenchoosingeCOAtechnology,sponsorsneedtoverifythattheycangetthedataoutoftheplatformquickly,securelyandwithlittleeffort.Thatmeansvettinghowdatasecurityandprivacyismaintainedateverytouchpoint,andwhatstepsarerequiredtomovethedatathroughthesystem.Ideally,thedatatransferprocesswilloccurthroughAPIsthatpulldatafromoneapplicationandsenditdownstreamtoanotherwithoutanyhumansinvolved.OncetheseAPIsaresetup,thedatashouldshowupinthedestinationsystemwithoutanyadditionalloginsorinteractionswiththeplatform.Suchseamlessintegrationsfreesitestafffromhavingtodealwithtechnicaldatataskstheyarelikelynottrainedforandensurefastandconsistentdeliveryofdatawhileadheringtodataprivacy/ecoa3BestPracticesforvettingeCOAtechFactoringtheneedsofpatients,sitestaffanddataintotheeCOAtechnologyvettingprocessisthekeytochoosingthebesteCOAplatformforanytrial.Thoughthatisn’tallthatsponsorsneedtoconsider.Timing,testingandvendorsupportwillallimpactsuccessfuldeployment.testingandvendorsupportwillallimpactsuccessfuldeployment.Dependingonthetechnology,theassessmentandtheneedforcustomizationandtraining,rollingoutaneCOAplatformcanaddweekstothetrialtimeline.Planningaheadandtalkingtovendorsabouthowtheycanacceleratethosetimelineswillhelpsponsorsspeeddeploymentandensureaseamlessuserexperiencefromdayone.Theweeksleadinguptothetriallaunchcanfeeloverwhelming,especiallyforsmallersponsorswithlimitedresources.HavinganeCOAsystemalreadyinplaceandworkingwithatrustedtechnologyvendorfreesstudyteamstofocusonothertaskscriticaltostudystart-upandensurespatients’firstinteractionswithtrialtechnologywillsetthestageforanexcellenttrialexperience.4eCOATechnologyGuideHereare7bestpracticestohelpsponsorsmakethebesteCOAtechnologydecision:1.Determinewhethertheplatformmeetsallregulatoryrequirementsfordataprivacyandsecurity.Thisisespeciallyimportantifthetrialwillbeglobal,aseverycountryhasuniquerulesgoverninghowdataiscollected,transmitted,sharedandstored.2.Chooseaplatformthatintegrateswithyourexistingtrialsystems.Ideally,theeCOAwillworkseamlesslywithintheclinicaltrialtechnologynetwork.Thisreducesthenumberofsystemssitestaffneedtouseandacceleratessponsors’accesstodata.3.Asksitestaffwhattolookfor.IftheyhaveusedeCOAsinthepast,theywillhavealistofthingstheyloveandhateabouttheseplatforms.Usethatlistwhenvettingyourvendors.4.Buildintimeforvalidationuseracceptancetesting(UAT).AnyassessmentusedinaneCOAhastobeproventoperformasexpectedonallpotentialoperatingsystemsandshowthattheintentoftheassessmentismetthrougheveryinteraction.Somevendorshavepre-builtAPIsandlibrariesofpre-validatedassessmentsthatcanbedeployedovernightwhileothersbuildandtesteachmodelseparately,whichcanaddmanyweekstothedeploymentprocess.5.Makesuresponsorsmaintaincompletecontroloverthedata.Sponsorsneedcontrolovertheirdatainordertopullitwhenevertheywantorneeditfortheirstudy.6.Meetyourpointofcontact.AdedicatedprojectmanageristhemostimportantpersonontheeCOAteam.Yourvendorshouldassignapointofcontactwhowillbeavailabletosolveproblems,answerquestionsandmakesurethetechnologyworksasexpected.7.Reviewtrainingmaterials.Sitestaffandpatientshavelittlepatienceforextensiveusertrainingoraplatformthatrequiresfrequenttrainingupdates.Whenreviewingtrainingmaterials,con