deliverable 1.3 evaluation of protocol feasibility, requirements for clinical … · 2016-03-16 ·...

EHR4CR

ElectronicHealthRecordsforClinicalResearch

Deliverable1.3Evaluationofprotocolfeasibility,requirementsforclinicaltrialexecutionandseriousadverseeventreporting

Version2.0

12thAugust2014

Projectacronym:EHR4CRProjectfulltitle:ElectronicHealthRecordsforClinicalResearchGrantagreementno.:115189Budget:16millionEUROStart:01.03.2011-End:28.02.2015Website:www.ehr4cr.eu

TheEHR4CRprojectispartiallyfundedbytheIMIJUprogramme

Coordinator:

ManagingEntity:

EHR4CR

D1.3Evaluationofthepilots,initialcritiqueoftheplatform 2

Document description

Deliverable no: 1.3Deliverable title: Evaluationofprotocolfeasibility,requirementsforclinicaltrialexecutionand

seriousadverseeventreportingDescription: ThisdeliverablereportsprogressonalltaskswithinWorkpackage1,including:

• pilotsiteevaluationsoffirstscenario:protocolfeasibility;• theformaldefinitionofthefinalscenarioanditssoftwarerequirements;• progressondevelopingappropriategovernanceinstrumentsforthe

platform,servicesandusers;• indepthinterviewsurveysofseniorleveldecisionmakersonthe

acceptabilityandbenefitsoftheEHR4CRplatform.

Status: Final, Revised Version: 2.0 Date: 12thAugust2014Deadline: February2014Editors: AndreasSchmidt,DipakKalra Outputs: Type Description CommunicationVehicle

Report xx xx

xx xx xx

xx xx xx

Other xx xx

Document history Date Revision Author(s) Changes 11/3/2014 0.1 Dipak Kalra Integrating initial contributions

from all task leads 12/8/2014 2.0 Dipak Kalra Updated deliverable with revised

title, clearer relationship to the DoW

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TableofContents

1 ExecutiveSummary..........................................................................................................................5

1.1 RelationshiptotheDescriptionofWork...................................................................................5

2 Pilotevaluationcriteria.....................................................................................................................7

2.1 WorkdoneforPFS.....................................................................................................................7

2.2 Challenges..................................................................................................................................8

2.3 WorkdoneforPatientRecruitment&identificationScenario(PRS)........................................9

3 ScenariosandrequirementsspecificationforClinicalTrialdataExchangeandSeriousAdverseEventReporting.....................................................................................................................................10

3.1 Introduction.............................................................................................................................10

3.2 Objectives................................................................................................................................10

3.3 Problemsbeingaddressed.......................................................................................................10

3.4 Approachandactivitiesundertaken........................................................................................11

3.5 Resultsandoutputs.................................................................................................................12

3.6 Relationshiptotherestoftheproject.....................................................................................12

3.7 Nextsteps................................................................................................................................13

4 InformationGovernance................................................................................................................14

4.1 Scopeoftheworkoninformationgovernance.......................................................................14

4.2 Objectives................................................................................................................................14

4.3 Activitiesundertaken...............................................................................................................15

4.4 Resultsandoutputs.................................................................................................................15

4.5 Relationshiptotherestoftheproject.....................................................................................15

4.6 Nextsteps................................................................................................................................15

5 Stakeholderengagementsurveyresults........................................................................................16

5.1 Background..............................................................................................................................16

5.2 Methods...................................................................................................................................16

5.3 Results.....................................................................................................................................16

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5.4 ConclusionsandimplicationsforEHR4CR...............................................................................18

5.5 KeyObjectivesfor2014...........................................................................................................18

6 ListofAnnexes................................................................................................................................19

6.1 Annex1-EvaluationoftheEHR4CRProtocolFeasibilityScenario..........................................19

6.2 Annex2-EHR4CRProtocolFeasibilityQuestionnairev1........................................................19

6.3 Annex3-PFSFinalEvaluationPoster......................................................................................19

6.4 Annex4-ScenariosfortheEHR4CRPlatformandBusinessModel........................................19

6.5 Annex5-ClinicalTrialExecution&AdverseEventReportingSoftwareRequirementsSpecificationv1.0..............................................................................................................................19

6.6 Annex6-ResearchDataReuseCodeVersion1......................................................................19

6.7 Annex7-StandardOperatingRules(advanceddraft)............................................................19

6.8 Annex8-InitialrecommendationsforIGproducts................................................................19

6.9 Annex9–Stakeholdersurveyresults......................................................................................19

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1 Executive Summary

ThisdeliverablereportsonprogressmadeacrossalltasksinWorkpackage1.Theoriginallyintendedfocusatthisstageoftheproject,asenvisagedintheDescriptionofWork,isevaluationoftheusemadeoftheEHR4CRplatformbythepilotsites,andthisisprovidedhereforthefirstimplementedscenario:protocolfeasibility.Theequivalentevaluationforthesecondscenario,patientidentificationandrecruitment,isinprogressandwillbereportedlater.

Theevaluationworkhasbeeninitiatedandsupportedthroughadedicated“Task1.5team”.TheteamprimaryfocuswastodevelopevaluationprotocolsfortheProtocolFeasibilityScenario(PFS)andthePRS(PatientRecruitmentScenario),andtocoordinatetheexecutionofactivitiesrequiredtogeneratethedataneededaspertheevaluationprotocols.Unanticipatedissues,mainlyduetoresourcesavailability,havesurfacedduringtheplanningandtheexecutionphases.Technicalissueshavebeenencounteredaswell.Sofarthedeviationfromplanisminimal.

TheiterativeandstepwisedevelopmentoftheplatformmeansthatduringthisyearWP1hasalsooverseentheformalisationofthefinalcombinedscenarioforclinicaltrialdataexchange(withEHRs)andseriousadverseeventreporting.D1.3thereforecontainsthescenariodescriptionandtheSoftwareRequirementsSpecification,thelatterbeingtheformalhandoverdocumenttoWorkpackageGroup2whichimplementsthespecifiedplatformfeaturesandservices.

Theconsortiumisnowpreparingforthesustainabilityoftheseservices,whichisdescribedinmoredetailinDeliverable2.3.Animportantaspectofscalingupandwide-scaleacceptanceisgovernance.Thisdeliverablealsooutlinestheapproachthathasbeentakenforwardthisyearondevelopinginstruments(codesofpractice,standardoperatingrules)thatcanbeevaluatedbyourexistingpilotsitesandwillbeusedtoassuretheprocessforsigningupadditionalhospitalsasdataproviders,andresearchsponsorsasusersofEHR4CR,duringthefourthandproposedfifthprojectyear.Theworkingversionsofsomekeyinstrumentsareincludedinthisdeliverable.

Finally,andimportantly,thisdeliverablereportstheresultsofaninterviewsurveyofseniorleveldecisionmakersinhospitals,publicbodies,patientassociationsandministries.ThissurveyhasexaminedtheattitudestoEHR4CR,perceivedbenefitsandacceptanceofourapproachtopatientprivacy(tocomplementandextendtheresultsofoure-surveyundertakeninyear1).

Thisdeliverableprovidesshortprogresssummariesonalloftheaboveareas,andprovidestheactualresultsasAnnexes:thesearetheactualdocumentsthathavebeenusedbytheprojectduringtheyearasformalisedresultsoradvanceddrafts.

1.1 Relationship to the Description of Work

IntheoriginalDoWamorewaterfallplatformdevelopmentmethodologywasforeseen,andatthisstageoftheprojectitwasexpectedthatWorkpackage1wouldbefocusingontheevaluationoftheplatforminthepilotsites.Inpractice,thedesignandimplementationofeachofthescenarioshasbeenprogressedasindependentcycles:thishasbeenhelpfulinenablingtheprojecttoexperiencethefullcycleforProtocolFeasibilityandusingthelessonslearnedfordownstreamscenarios.Itshouldalsobeennotedthattherequirementsanalysesandthesubsequentplatformimplementationforthisfirstscenariohastakenlongerthanexpected,duringyears1and2oftheproject.Asa

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consequence,Workpackage1,andthisdeliverable,isreportingtheevaluationundertakenoftheProtocolFeasibilitydeployment(Section2ofthisreport)andalsoreportingprogressindevelopingtheSoftwareRequirementsSpecificationforClinicalTrialdataExchangeandSeriousAdverseEventReporting.Progressondevelopinginstrumentstosupportinformationgovernance,andananalysisofkeystakeholderopinionsoftheEHR4CRapproach,arealsoreportedhere.TheseareasofprogressareinlinewiththetasksofWorkpackage1,althoughwerenotspecificallycontractedtobeprovidedinthisdeliverable.

ThecontributionstothisdeliverablefromeachoftheWP1tasksareshowninthetablebelow.

Workpackage1Tasks SpecificactivityinYear3,reportedinD1.3Task1.2StakeholderNeeds,Opportunities,&Challenges

InterviewsurveysofseniorleveldecisionmakersontheacceptabilityandbenefitsoftheEHR4CRplatform

Task1.2SpecificScenariosfortheEHR4CRPlatformandBusinessModel

ThesetwotaskshaveworkedtogetherontheformaldefinitionofthefinalscenarioanditssoftwarerequirementsTask1.3Requirements

Task1.4GovernanceSuccessFactors Developingappropriategovernanceinstrumentsfortheplatform,servicesandusers

Task1.5EvaluationofthePilots Pilotsiteevaluationsoffirstscenario:protocolfeasibility

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2 Pilot evaluation criteria

AdedicatedteamwasformedtoconductactivitiesrelatedtoTask1.5-EvaluationoftheDemonstrationPilots.

TheteamprimaryfocuswastodevelopevaluationprotocolsfortheProtocolFeasibilityScenario(PFS)andthePRS(PatientRecruitmentScenario),andtocoordinatetheexecutionofactivitiesrequiredtogeneratethedataneededaspertheevaluationprotocols.

Unanticipatedissues,mainlyduetoresourcesavailability,havesurfacedduringtheplanningandtheexecutionphases.Technicalissueshavebeenencounteredaswell.Sofarthedeviationfromplanisminimal.

Someproblemshavebeensuccessfullyaddressedwhileothershavepreventedthetimelycompletionoftheprotocols.Theactivitiesareon-goingandareexpectedtobecompletedduring2014.

Thenumberofparticipatingsiteswasdefinedbythelistofstudyprotocolsqualifiedfortheevaluation.ProtocolsinclusionsandexclusionscriteriawerenormalizedandprogrammedonthelocalsiteEHRsdatawarehouses.

ThelistofprotocolswasprovidedbyWP7(Pilots).

Adedicatedevaluationprotocolhasbeendevelopedtodocumenttheevaluationcriteria.Aninvestigatorquestionnairewasdevelopedtocollectestimatedenrolmentthroughlegacypractices.

AnadditionalpilotisconsideredforPFSandPRStofullyexploreotherareasleftunaddressed.

2.1 Work done for PFS

Anacceptableandrobustmethodforconductingevaluationworkhasbeendeveloped.

Anevaluationprotocolhasbeendeveloped,withaprimaryfocusondemonstratingtheaccuracyofthenumbersproducedusingEHR4CRplatform.ThesecondaryobjectivewastoevaluatethetimesavedusingEHR4CRplatform.

Anevaluationprotocolentitled“EvaluationoftheEHR4CRProtocolFeasibilityScenario”hasbeenproducedandisattachedtothisdocumentasAnnex1.

Theactualexecutionoftheplannedprocedureswasconductedincoordinationwiththeworkpackage7(WP7).

Thefollowingachievementshavebeendeliveredduringtheyear2013.

- InitiationofTask1.5,includingteamformation.- ProductionoftheevaluationprotocolforthePFS- Productionoftheinvestigatorquestionnairetosupporttheexecutionoftheevaluation

protocolAnnex2.

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- ApostersummarizingtheevaluationofthePFSwasdemonstratedattheannualmeetinginBerlin–Annex3.

2.2 Challenges

Somechallengeswerefacedduringthedevelopmentandtheexecutionoftheplan.

Someoverlapsofactivitiesandresponsibilitiesbetweenthetask1.5teamandtheWP7team,havebeenaddressedandresolved.IthasbeenagreedtofocusTask1.5effortonthedevelopmentoftheevaluationprotocolsandsupportivedocuments.TheactualexecutionoftheactivitiesrequirestoconducttheevaluationshavebeendefinedasbeingoftheresponsibilityoftheWP7.

TheneedforaclosecoordinationwithWP2,tomanagetheexpectationsintermofplatformavailabilityandaccessibilitywasidentifiedascritical.Actionshavebeentakentoimproveandsecureadequatecoordinationandcirculationofthestatusupdateacrossimpactedteams.TheneedsfromTask1.5teamandfromWP7havebeenincorporatedintotheWP2workingplan.

Finally,anunanticipatedissuerequiresbecorrectlyassessingandaddressed.Theexecutionoftheevaluationproceduresattheclinicalsitesgeneratesasignificantworkload.AsaresultthecompletionoftheevaluationprocedureshastakenmoretimethaninitiallyanticipatedandisnowexpectedtobefullycompleteduringQ12014.TheworkloadandstaffavailabilityatthesitewillbeassessedforupcomingPilotevaluationactivities.

BelowisasummaryofspecificchallengesspecifictothePFSevaluationproceduresthatwereaddressed.

- Selectionoftrials:10studiesusedfortheProofOfConcept(POC)oftheEHR4CRProtocol

FeasibilityScenariowereincludedintheevaluation.

- Goldstandard:abaselinevaluewasdefinedasthevalueproducedusingamanualcheckof

patientrecord–thisvaluehasbeendefinedasthe“GoldStandard”.Togetthisvalueimplies

themanualcheckofpatientrecords,100randomsubjectspertrial(withthepossibilitytouse

thesame100recordsfortrialswiththesamescope/disease).Thistaskwillbeperformedby

thePrincipalInvestigators(PIs)ormedicalexpertsatthesite.

- EstimationofthePrincipalInvestigators:Astandardquestionnaireformhasbeenproduced

(Annex2)andcustomizedbyeachindividualEFPIAmemberstomatchtheirprotocolsand

weresenttothePrincipalInvestigatorsinvolvedattheparticipatingsite.Thisprovidedthe

figuresresponsesusingthetraditionalfeasibilityprocess.

- SiteEthicalCommittee’sApproval,eachparticipatingsitehasmanagedtheprocesstoobtain

thenecessaryinternalapprovals.TheHôpitalUniversitairedeGeneve(HUG)hasrequested

tobeprovidedwithasubmissionpackagetogaintheirlocalapprovaltoproceed.Thisis

underdevelopmentandwillbeavailableforthenextiterationorevaluationprotocol.

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2.3 Work done for Patient Recruitment & identification Scenario (PRS)

AfirstdraftoftheevaluationprotocolhasbeendevelopedduringQ42013.ItisexpectedtohavethefinalprotocolduringQ12014.ThedevelopmentoftheplatformforthePRS,hastakenmoretimethaninitiallyplanned. It isnowscheduledtobeavailableduringQ12014.Theevaluationprotocolisbeingdevelopedtomeetthesiteethicscommitteerequirementsandwillserve toobtain thenecessary internalapproval toconduct theevaluationprocedures.Thiswork isbeingdoneinveryclosecollaborationwithWP7.AdetailedstatusreportonthisevaluationwillbeprovidedinDeliverable1.4.

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3 Scenarios and requirements specification for Clinical Trial data Exchange and Serious Adverse Event Reporting

3.1 Introduction A well conducted requirements gathering and analysis process is an important first step in thedevelopment of a usable and efficient application. This process consolidates all needs, constraintsandrequirementsinastructuredwaywithinscenarioandsoftwarerequirementsspecification(SRS)documents.

FourclinicalresearchscenarioshavebeendefinedwithinthescopeofthisprojectandprioritizedbytheExecutiveCommittee:

1. Clinicalprotocolfeasibility2. Patientidentificationandrecruitment3. Clinicaltrialexecution4. Adverseeventreporting

During Year 3we have completed the scenario and requirements definition for Clinical Trial DataExchangeandforAdverseEventReportingandthisformsthefocusofDeliverable1.2

3.2 Objectives • DefineoperationalscenariosforthedomainofClinicalTrialdataExchangeandAdverseEvent

Reporting• Definesystem(platform)requirementsbasedonoperationalscenarios,stakeholderinputs,and

inputsfromstaffatthepilotsites• Developusecasesandworkflowstoelaboratetherequirementsandsteerthedevelopmentof

toolsandservices• Finalisationoftheclinicaltrialexecutionsoftwarerequirementsspecification• Finalisationofsubjectidentificationandrecruitmentsoftwarerequirementsspecification

3.3 Problems being addressed Theinefficienciesoftoday’sseparatedprocessforcaptureofpatientcareandclinicaltrialdataareobviousattheclinicaltrialinterface.Itisestimatedthatasmuchas40%ofclinicaltrialdataareenteredintoboththepatient’shealthrecord,theclinicaltrialEDCsystem(and,possibly,athirdpapercopy)1,butthereisevenaperceptionbyclinicalstaffthatthisismorethan70%2.

Thisdividedenvironmentresultsin:

• Cumbersomeandslowprocesses

1IntegratingElectronicHealthRecordsandClinicalTrials:AnExaminationofPragmaticIssues,MichaelKahn,UniversityofColorado2EDCSiteSurvey:InvestigationalSitePerspectivesonClinicalTrialInformationSystems,eClinicalForum2009.Availableat:www.eclinicalforum.org(accessedDecember1,2011).

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• Redundantdataentry• Transcriptioninconsistencies• Sourceissues

Theabilitytoexchangedatabetweenhealthcareandresearchdatabaseswould…

• Reduceredundantdataentrybypre-populatingeCRFswithdataalreadyheldwithinthelocalEHR

• Avoiddatatranscriptionerrorsrelatedtomanualtranscriptionerrorsthatcostsiteandsponsorstafftimeandefforttodetectandresolve

• Clarifythe‘source’issuebyknowingthereliabilityofsourcedata• IncreaseClinicalTrialefficiencyleadingtohigherinvolvementoftreatingphysiciansin

ClinicalTrialssastheirdailyworkislessnegativelyimpacted

AdrugadverseeventoccurringinaclinicaltrialtodayfrequentlytriggersaseparatemanualprocessfromdatacaptureintoresearchEDCsystems.AlthoughseveralcompaniesandEDCvendorshavemadeinroadsintostreamliningtheprocessbyenteringadverseeventdatawithintheEDCtoolratherthanviaaseparatepaperform,amoreefficientprocesswouldcapturedatabydirectlyconnectingtothelocalEHRsystem.Suchanapproachwillenhancecompleteness,qualityofdata,timelinessandregulatorycompliance.

3.4 Approach and activities undertaken TherequirementsengineeringprocessadoptedwithinEHR4CRprovidesamethodologyforthethoroughexaminationoftheenvisagedoperationalenvironmentandspecificationofapplicationfunctionalitiesandbehaviours.Thefollowingactivitieshavebeenundertaken:

• Interviewswithexpertsfrompharma,healthcare,academia,EHRvendorsandResearchEDCvendorstodevelopacomprehensiveunderstandingofthecurrentprocessforclinicaltrialdataexchange,userissuesandneeds

• CompilationofRequirementsScenariosfortheClinicalTrialDataExchangedomain• ConceptualmodellingoftheClinicalTrialDataExchangedomainscenarios(UMLusecase

diagramsanddescriptions)• BrainstormingandRequirementsElicitationWorkshopsinBasel(18.03.2013-19.03.2013)and

Leverkusen(27.05.2013-29.05.2013)withprojectmembersrepresentingusergroups• CompilationoftheSoftwareRequirementsSpecification(SRS)andtheirreviewand

improvementwithinWP1o iterativeandincrementalrequirementsengineeringapproacho amendmentofclinicaltrialexecutionspecificationo identificationofworkshopparticipantsbasedonskillsetso identificationofend-usersandactorsinvolvedinclinicaltrialexecution

• Releaseoftheinformalcapabilitiesdescriptionatthe08/05/13

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• RequirementselicitationandanalysisworkshopforclinicaltrialexecutioninLeverkusenfrom27/05/13until29/05/13

• EDCdataintegrationworkshopinLeverkusenfrom11/06/13until13/06/13• Reviewcyclesforclinicaltrialexecution

o 1streviewcyclefrom08/07/13until22/08/13o 2ndreviewcyclefrom22/08/13until13/09/13

• Releaseoftheclinicaltrialexecutionsoftwarerequirementsspecificationat08/10/13o preparationofStageGateandStakeholderAwarenessSession(18/11/13)inBerlin

• StageGateProcess:RequirementsFreeze

3.5 Results and outputs ThemainoutputsofTasks1.2and1.3comprise:

1. ScenariosfortheEHR4CRPlatformandBusinessModel(Annex4)containingrelevantdomainandusagescenariodescriptions.

2. ClinicalTrialExecution&AdverseEventReportingSoftwareRequirementsSpecificationv1.0(Annex5)containingthefollowinginformation:

• Tools,methodsandapproach• Adescriptionandresponsibilitiesofthekeyactors/roles• Usecasesthatspecifytheenvisagedinteractionofactorswithcomponentsofthe

envisagedsystemo Identified28practicalusecasesandrequirementsforsubjectidentificationand

recruitmento GUIMock-upstodemonstrateenvisagedfunctionalityofthesoftware

• Clinicaltrialreportingfunctionalitybasedonastate-diagramonpatientstatesinaclinicalstudy(patientidentificationandrecruitmentphase),basedonsurveywithEFPIApartners

• Functionalrequirements• Non-functionalrequirements(processandqualityfactors)• DataRequirements

3.6 Relationship to the rest of the project Therequirementsscenariosandspecificationsprovideinputfor:

• Technicalworkpackagemembers,whowilltranslatetheusecasesandrequirementsintoasoftwaresystem.

• Pilotworkpackagemembers,whowillusetheSRSfortheuseandevaluationofthedevelopedsoftware.

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3.7 Next steps Plannednextsteps:

• Publicationoftherequirementsengineeringprocess• Changecontrol• Nextiterationphaseforrefinementofrequirementsduringthepilotstestphaseforall

scenarios• Consolidationandupdateofscenariosintoafinaldeliverable,baseduponfeedbackduring

developmentandpiloting.• Publicationofallrequirements

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4 Information Governance

4.1 Scope of the work on information governance ThroughouttheIMIaneedforacoordinatedapproachtoaddressdataprotectionconcernsbecamemoreandmoreevidentduring2013.ThereforeuponinitiativeoftheEHR4CRmanagingentity(the“convergence initiative”) a number of projects from DG Connect and IMI widely agreed to tacklesome common challenges together. One of the key questions regarding “secondary use of healthdata” was taken up by Anne Bahr (Sanofi) and integrated in the work of EHR4CR, where it waspursuedwith the contributionof TMF (Germany). A “code for secondaryuseofhealthdata”wasinitiated.FollowingcontactswiththeEuropeanDataProtectionSupervisorofficeitwasdeterminedthattheycouldprovideaformaladvicetoanEUbodyoragencysuchasIMI.ActionforIMI:supportthereviewbyhighlevelexpertsandsubmittotheEuropeanDataProtectionofficeforformalreview.

During the preparation of the pilotswithin EHR4CR, it has also become evident, that the EHR4CRProjectneedsarangeofpolicydocumentswhichlaydownhowtheEHR4CRPlatformwilloperateinpractice,coveringbothwhatisexpectedfromtheparticipatingsponsorsandhospitalsaswellastheProjectitselfandhowthiswillbecontrolledorenforced.

TheExecutiveCommitteeofEHR4CRhasthenrecognised,thatitisappropriatetobringtogethervariousstrandsofwork[noterelevantWPsanddeliverables]underan‘InformationGovernanceTaskForce’whichwillreviewlegalandsystemrequirementsandhowtheseneedtooperatewithorganisationalpoliciesandproceduresunderaframeworkofcontractsoragreementstoensuresafeandeffectiveuseofsensitivepersonalinformation,ensuringlegalandethicalconformancebytheEHR4CRInstituteandallparticipatingentities.

TheIG-TFisledbyPeterSingleton,AnneBahrandIreneSchlünderandchairedbyProf.DipakKalra,whowillalsoactastheSeniorInformationRiskOfficer(SIRO)onbehalfoftheEHR4CRproject.Thefirstproductfromthetaskforcewillbeadocument,‘EHR4CRStandardOperatingRules’whichwilllayoutpreciserulesfortheoveralloperationintermsofsystemrequirementsandorganisationaloperations.Oncecompletethensubsidiarypolicyandproceduredocumentscanbeidentified.Theproceduraldocumentsmaybeproducedastemplatesforcustomisationtothepreciseneedsofparticularorganisations,reflectingtheirrelationshipswithotherparticipatingentities.Similarly,templates(orheadsofagreement)maybeproducedtoidentifykeyaspectsthatneedtobeincorporatedinformalcontractsoragreementsbetweenparticipatingpartnersintheirdifferingroles.

4.2 Objectives • Thedocuments–andcontractsderivedfromthem-willserveasabasisformutualtrustduring

thepilotphase.• Fromthesedocuments,appropriateprocessesandprocedurescanbedeveloped,eitherwithin

thePlatform,asexemplartemplatesbytheprojectforotherstouse,orbyotherstofitwiththeirownparticularcircumstances,butinaccordancewithestablishedpolicies.

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• ThedocumentswillthenalsoserveasaninformationgovernanceframeworkofthefutureEHR4CRInstituteandsupportseveralservicesoftheInstitutee.g.accreditationandcertificationservices.

4.3 Activities undertaken Themainactivitiesundertakenduring2013havebeentoworkontheCodeforReuseandtheStandardOperatingRules,andtoprovidesupporttoWP7onthedevelopmentofagenericprotocolthatmaybeusedbyhospitalswhenrequestingconnectiontotheEHR4CRplatform.Thefollowingworkshopshavealsobeenheld:

• TheConvergenceworkshop–Brussels20thand21stMarch2013• Audit&Monitoringworkshop–London11thFebruary2014• StandardOperatingRulesReviewWorkshop–London12thFebruary2014

4.4 Results and outputs Themainoutputscomprise:

1. TheResearchDataReuseCodeVersion1(firstversionsharedwithinIMIforrevision,Annex6)

2. TheStandardOperatingRulesversion0.9(advanceddraft,Annex7)3. InitialrecommendationsforIGproducts(Annex8)4. InformationGovernance(Framework)–advisorypapertoExCo(internaldocument)

4.5 Relationship to the rest of the project Thedocumentsprovideinputfor:

• Technicalworkpackagemembers,whowillreassurethatthedevelopedsoftwaresystemisinaccordancewiththerulesandpolicies.

• Pilotworkpackagemembers,whowillusethedocumentsasbasisformutualtrustduringthepilotphase.

4.6 Next steps Plannednextsteps:

• AdoptingtheCodeofConductthroughoutIMIProjects• InternalrevisionandimprovementoftheSORs• Developingcontractualobligationforparticipantsofpilotsasneeded• DevelopmentofStandardOperatingProcedures

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5 Stakeholder engagement survey results

5.1 Background Theobjectiveofthistaskactivityistodetermineanddocumenttheconcerns,needs,opportunitiesandperceivedchallengesofthecomplexnetworkofstakeholdersimpactedbyEHR4CR.Therealitiesandcomplexitiesoflocal,nationalandinternationalcontextswillbeanalysedtoidentifykeyopportunitiesandbarrierstoprogress.IncentivesanddisincentivesforparticipationbyeachstakeholderinboththeEHR4CRdevelopmentstageandthelong-termsustainabilityplatformwillbeidentifiedanddocumented.

MaterialsfortheconductofstructuredinterviewswithseniorfiguresinhealthcareorganisationsacrossEurope(includingmanagersandinformationgovernancestaff,academics,clinicalopinionleaders,ethicistsandresearchfunders)weredevelopedbasedondetailedinterviewsconductedinapilotstudyinScotland.InterviewsfortheStakeholderEngagementsurveywereconductedbyseniormembersofWPG7staffwiththeaimofinterviewingkeypeopleintheirowngeographicarea.Theinterviewswereconductedinthesecondhalfof2012andthefirsthalfof2013.

5.2 Methods Atotalof37structuredinterviewswereconductedinGermany,theUK,SwitzerlandandFrance(Tables1and2).Theintervieweeswereprovidedwithadescriptionoftheprojectandstructuredinterviewswereconducted,initiallyfocussingonthefourprojectobjectives(trialfeasibility,facilitatingrecruitment,facilitatingclinicaltrialdeliveryandreportingofadverseofevents).Withineachobjectiveaseriesofscenarioswerepresentedandspecificquestionsposed.Inaddition,aseriesofquestionswereposedrelatingtoa)motivatingfactorsforahospital/academictoparticipateintrialsusingtheproposedEHR4CRplatformandb)threatsandchallengestothesuccessofanEHR4CRplatformtosupporttrials.Finally,intervieweeswereaskedtogivetheiroverallimpressionoftheEHR4CRproject.

5.3 Results PleaserefertothedetailedresultsinAnnex9ofthisdeliverable.

Clinicaltrialfeasibility:AclearmajorityofintervieweesdidnotfeeltherewasarequirementforpriorpatientconsentforuseofanEHR4CRplatformthatpermittedqueriestoberunonlocalhospitaldatawarehouses,returningcountsofpotentiallyeligiblepatientforaspecifictrial.However,asignificantnumberofrespondersthoughtthatpriorconsentwouldberequiredforthereturnofde-identifiedindividualpatientlevelinformationtothepartyinitiatingthequeryortoatrustedthirdparty.(Figures1-4)

Similarresponseswereobtainedwhentheintervieweeswereaskedabouthealthcareinstitutionalapprovalconcernsinrelationtotheproposedscenarios(Figures5-8)andtoinformationgovernanceconcerns(Figures9-12)withparticularlystrongconcernsaboutanytransferofindividualpatientdatatothirdparties.IntervieweeswereunanimousthatAnEHR4CRplatformapproachtoassessing

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feasibilitywouldenhancetheconductofclinicaltrials(Figure13)andaclearmajorityofrespondersindicatedthatthisapproachwouldreduceworkloadsintheassessmentofclinicaltrialfeasibility(Figure14).

FacilitatingRecruitmenttoTrials:Thisscenarioassumes,onceatrialhadbeeninitiatedandaclinicaltrialcontractexistedwiththehealthcareorganisationsinvolved,thattheEHR4CRplatformwouldbeusedtoprovidethelocalclinicaltrialinvestigatorwithalistofpotentiallyeligiblepatientsforthetrial.Approximately50%ofrespondersthoughtthatthisapproachmightneedpriorpatientconsenttousetheirdatainthisway(Figure15).Similarnumbersthoughtthatspecificdataprotectionorregulatorybodyapprovalwouldberequired(Figure16).Approximately70%thoughtthatthisapproachwouldbeapprovedbyhealthcareorganisationsintheircountryandaclearmajoritythoughtthatthisapproachtofacilitatingrecruitmentwouldenhancetheconductoftrials(Figures18(ethicscommitteeresponders),20(non-ethicsresponders)).However,approximately50%ofrespondersthoughtthatthisapproachwouldcreateeitherethicsorinformationgovernanceconcernsintheircountry.

FacilitatingClinicalTrialDelivery:Thisscenarioassumesthatatrialhasbeeninitiatedataclinicalsiteandthatpatientshavebeenrecruitedandhavegiveninformedconsenttoallstudyproceduresanduseoftheirelectronicpatientrecordswithinthetrial.ThescenarioproposedwasthattheEHR4CRplatformwouldbeusedtoextractpre-specifieddatafromthepatients’electronichealthrecordsandpotentiallyreturnadditionaldatacollectedinthecontextofthetrialtothepatients’records.Approximately70%ofrespondersthoughtthatthisapproachtodataextractionwouldreceivehealthcareinstitutionalapprovalandsimilarnumbersthoughtthatthiswouldnotraiseinformationgovernance/ethicalconcerns(Figures21,23).Aclearmajorityofrespondersthoughtthatthisapproachwouldenhancetheconductoftrials(Figures22,24).

Whenaskedaboutthereturnofclinicaltrialdatatothepatientrecord,50%(70%)respondedthatthiswouldreceiveethics(institutional)approval(Figures25,26).Morethan65%ofrespondersthoughtthattherewasadangerthatdatafromtrialthathadbeenaddedtothepatientrecordcouldleadtomisunderstandings.However,mostthoughtthatconcernswouldbereducediftheadditionaldatawerekeptseparatefromtheusualpatientrecord(Figures27,28).

FacilitatingAdverseEventReporting:ThiscontextconsideredtwoscenariosthatwouldpotentiallyinvolvetheuseoftheEHR4CRplatform,firstlytheautomaticreportingofadverseeventswithinthecontextofaclinicaltrialwithassociatedinformedconsentandsecondlythereportingofadversedrugreactionsinapost-marketingcontext.

Inthefirstscenario,only50%wereconfidentthatthiswouldreceiveethicalapprovalwithsimilarnumbersindicatingthatthisapproachwouldraiseinformationgovernanceconcerns.However,themajorityofrespondersthoughtthatthisapproachcouldenhanceadverseeventreportingandevaluationofthesafetyofmedicines(Figures29-31).

Forthescenarioofpostmarketingsurveillance,although60%ofrespondersthoughtthiswouldreceiveinstitutionalapproval,similarnumbersthoughtthatpriorpatientconsentwouldberequiredandthattherewouldbesignificantethical/informationgovernanceconcerns.Mostrespondersindicatedthatdataprotectionorotherexternalapprovalswouldberequiredfortheadoptionofthisapproach(Figures32,33).

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FactorsmotivatingfutureparticipationinanEHR4CRplatform:ThestrongestmotivatingfactorsforfutureparticipationinanEHR4CRplatformwereincomegenerationfromindustrytrials,providingpatientswithfasteraccesstonovelmedicines,stimulusforthedevelopmentoflocalhealthinformationsystemsandimprovedqualityofhealthcaredata,potentialtousetheplatformforacademicstudies,improvementinthequalityandefficiencyoftrials(Figures34-37).

PotentialthreattothesuccessofEHR4CR:ThebiggestthreatsraisedtothesuccessofEHR4CRwere,theinadequacyoflocalhealthinformationsystemsandormissingkeydataitems,thecostofupgradingsystemsandethical,dataprotectionandinformationgovernanceconcerns.Respondersweresplitontheimportanceofhospitalmanagementconcernsandtheconcernsofpatientsandclinicians(Figures38-42).

OverallsupportfortheobjectivesofEHR4CR:ThevastmajorityofrespondersagreedorstronglyagreedwiththeoverallobjectivesofEHR4CR(Figure44).

5.4 Conclusions and implications for EHR4CR TherewasclearsupportfortheoverallobjectivesofEHR4CRandabeliefthatawelldevelopedEHR4CRplatformwouldreduceworkloadsandimprovetheconductandqualityoftrials.However,theintervieweesdidraisesomeethicalandinformationgovernanceconcernsandthreatstothepotentialsuccessofanEHR4CRplatformthatwillhelpguidethefinaldevelopmentoftheplatformandalsopointtoareaswherethereisaneedtoclarifyandemphasisedatasecurity,privacyandinformationgovernanceissuesintheroll-outoftheplatform.

5.5 Key Objectives for 2014 i) PublicationoftheresultsoftheinitialStakeholderEngagementSurveyii) DesignanddeliveryofaRegulatoryStakeholderSurvey

EHR4CR


6 List of Annexes

6.1 Annex 1 - Evaluation of the EHR4CR Protocol Feasibility Scenario

12pages

6.2 Annex 2 - EHR4CR Protocol Feasibility Questionnaire v1

2pages

6.3 Annex 3 - PFS Final Evaluation Poster

1page

6.4 Annex 4 - Scenarios for the EHR4CR Platform and Business Model

40pages

6.5 Annex 5 - Clinical Trial Execution & Adverse Event Reporting Software Requirements Specification v1.0

45pages

6.6 Annex 6 - Research Data Reuse Code Version 1

22pages

6.7 Annex 7 - Standard Operating Rules (advanced draft)

37pages

6.8 Annex 8 - Initial recommendations for IG products

3pages

6.9 Annex 9 – Stakeholder survey results

31pages

deliverable 1.3 evaluation of protocol feasibility, requirements for clinical … · 2016-03-16 ·...

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