Datasharingandtransparency:theroleofdatastandards

BarbaraE.Bierer,MDbbierer@partners.org

September28,2016CDISCInternationalConference

Disclaimer:

• TheopinionscontainedhereinarethoseoftheauthorsandarenotintendedtorepresentthepositionofBrighamandWomen'sHospitalorHarvardUniversity.

• TheMRCTCenterissupportedbyvoluntarycontributionsfromfoundations,corporations, internationalorganizations,academicinstitutionsandgovernmententities(seewww.MRCTCenter.org)andwellasbygrants.

• Wearecommittedtoautonomy inourresearchandtotransparency inourrelationships.TheMRCTCenter—and itsdirectors—retainresponsibilityandfinalcontrolofthecontentofanyproducts,resultsanddeliverables.

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Engagediversestakeholderstodefineemergingissuesinglobalclinicaltrialsandtocreateandimplementethical,actionable,andpracticalsolutions.

OurMission

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Nonprofits

Industry

Patientsand

PatientOrg

Academia

Gov’t

Journaleditors

DataSharingandTransparency

• Individualparticipant-leveldata(IPD)sharing

Purpose-drivenDataSharingWillEnhanceScientificDiscoveryAndPublicTrust

Benefits:• Eliminateduplicativetrials• Enablenewsciencediscovery• Enhancecorrelativeand

explanatoryscience• EvaluatecommonAEsby

compoundclassorsubpopulation• Identifysurrogateendpoints• Enhancepublictrust

Benefitsonlyrealizedif• Risksareminimized,withattentionto

participantprivacy– informedconsent/respectforconsent– Dataanonymization

• Wideparticipation:includingacademia,biotech,government,etc

• Dataareinteroperableanddatasetscanbepooled– Datastandardsareavailable,or

alternativemethodology– Metadataisshared– Real-timeanalyticsareavailable

• State-of-the-art securityisinplace

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ClinicalTrialDataSharing:MajorPlatforms

• CSDRPlatform- leadingindustrymulti-sponsorrequestsite• J&J- YODA project- YalepartnerswithJ&J/Medtronic• Duke ClinicalResearchInstitute– BristolMyersSquibbStrategic

Initiative(SOAR)• ProjectDatasphere – cancercomparatordata,andmore• NIHdatarepositoriesand(BIOLINCCand60+others)• FDA Oncology’sdataaggregationeffort- InformationExchangeand

DataTransformation (INFORMED),andothers• CancerMoonshot, andothers

CurrentlynotinteroperablenoraremostofthesesystemsintegratedFewvoluntaryacademicorbiotechdatageneratorparticipants

ClinicalTrialDataSharing:MajorPolicyInitiatives

• EMAPolicy70• BMJ andothers• ProposedICMJEpolicy (notaslamdunk)• NIHandFDAdatasharing(CT.gov reporting)andotherNIH

initiatives• BMGFdatasharingrequirements• Otherfundersandfoundations

Thetimeisnow.

CenterandBackground

TheMRCTCenterhaschampionedeffortstoenhancesharingof,andaccessto,clinicaltrialsdataaroundtheworld.

Vivliisbeingformedtoprovidegovernanceandmanagement ofaplatform—agnostictodisease,country,sponsorandfunder—to

reducebarrierstoclinicaltrialsdatasharing.

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1) Enablinginteroperabilityofdatafrommultiplesources;

2) Hostingdataforstakeholders thatdonothavetheabilitytodoso;

3) Coordinatingandpartneringwithexistingdata-sharinginitiatives,policies,andprocessesasappropriate;

4) Promotingreasonedsolutionstochallengesofdatasharing.

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Scope

5EssentialDomainsforPlatform

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PlatformTopicsIPDIntakeandCuration Mustbeabletointakeandcuratedatawith

flexibilitytoscaletonewtypesofdata

CatalogMetadataandDatasetIdentifiers

Musthaveaccuratestructuredmetadataanduniqueidentifiersforeachdataset,toenableprecisegranularsearching

ReviewProcessforRequests Mustbeabletoaccommodatedifferentreviewrequirementsandprocesses

AnonymizationandDUAs CriticaltomaintainparticipantprivacyAnalysisToolsandWorkspace Musthaveasecureanalysisspace,enabling

asmuchcross-datasetaggregationaspossible,withtheflexibilitytodevelopaccommodationofmanytypesoftools

TheUniqueRemitofVivli– EnhancingDiscovery

Advancedmetadatasearchanddiscovery capability

Simplified access request systemtodataresidingonotherplatforms

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Searchingmultipledatabasesina

fragmentedlandscape

Discovery ofdatacanbechallenging

Morecommunities andpartners=morediscoverabledata

Astheenhancedmetadatacatalogmatures,moredata,includingexternallyhosteddata,willbediscoverablethroughVivli

Vivli:ProvidingVisibilityandCombiningDatainaCentralizedPlatform

CombinedIndustry,Academic,andBiotechdatadiscoverable throughonesearchengine

Anonymized IndividualParticipant-LevelData(IPD)availableforrequest

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Anonymization

Data Generator

Anonymizationsimplified bystandardization

VivliSolutionsOfferings

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VivliSearchandRequestTool

VivliYodaCSDR

GSK Lilly Takeda RocheEtc. JnJ Medtronic Vivli

More

Other

IRP IRP IRP IRP

OpenSearch UserRequest ApprovedRequest

Secureanalytic

Environment

Dr.XData

Vivli

Yoda

GSK

Centralizedsearchandrequestportalfordatahostedonmultipleplatforms

EnhancedMetadataformoreprecisesearchresults

SecurespacetocombineIPDdatafrom

multiplesources,includinguploadofacademicdata

Hostingforclinicaltrialdata,includingmintingDOI forpublicationpurposes

Respectingothercontributorreview

processesanddatausetermswhileprovidinguserwithcentralizedmechanismforrequest

Examplesofexistingplatforms

EconomiesofScale

Policy• DataContributorandDataUseAgreements• DataPackagedefinitions• Harmonizationofreviewprocess• Policiesoncitationandpublicationofsecondaryanalyses

Technical• Standardizedandcomputablecatalogmetadata• StandardizedIPDdataformat(e.g.,SDTM,mappingintoSDTM)

• Uniformanonymizationstandardsandapproaches• Datasetidentifiersandlinkagemanagement

DataandmetadatacurationpipelinesbenefitfromscaleEasiertoapplystandardstoonedatahostingprocessformajorityofIPDdatasets

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Overcomingresistance

• Academicambivalence– Norequirement tochange

• FewFDA- orEMA-regulated,investigator-initiatedstudies

– Lackoffamiliarityandunderstanding– Somestandardsnotyetdevelopedornotwelldisseminated– Challengesofchange(e.g.training,IT,legacydata)– Costsoftransition(human,financial,systems)

• Approaches– Carrotsnotsticks(thenmandatorycarrots,andlastlysticks)– Fundingopportunitiesfordevelopmentofstandardsandforcollaboration– Regulatoryandadministrativeconvergence(e.g.US:NIH,FDA,OHRP,etc.)– Sciencedrivenbyacademia

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OpportunitiesOfferedbyVivli

• Hostingandcurationofdata• IncreasedDataDiscoverability

– Collaborationwithacademicsandothersnotcurrentlyparticipatingindatasharing

• EconomiesofScale

• HarmonizationofProcessesandPolicies– MRCTandVivliwillcontinuetopursueharmonizationeffortsanddata

authorstatusforacademiccredit– Alignmentofregulation,guidance,andrequirements forfunding

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DataSharingLeadershipTeam

MarkBarnes,FacultyCo-Director,MRCT

BarbaraBierer,FacultyCo-Director,MRCT

RebeccaLi,ExecutiveDirector,MRCT

KristenBolt,ProgramManager,MRCT

MarlaBrickman,SeniorDirector,Pfizer

StuartBuck,LauraandJohnArnoldFoundation

AnneClaiborne,SeniorProgramOfficer,IOM(nowNAM)

PatrickCullinan,Director,GlobalClinicalTrialTransparencyTakeda

JuergenKlenk,ManagementConsultant,Deloitte

MichelleMancher,ProgramOfficer,NAS

SandraMorris,VPStrategyRealization,JohnsonandJohnson

JenniferO'Callaghan,ClinicalDataSharingManager,WellcomeTrust

NicolaPerrin,HeadofPolicyforStrategyDivision,WellcomeTrust

Rohin Rajan,ManagementConsultant,Deloitte

FrankRockhold,DukeUniversity

JessicaScott,Director,NAMedAdvocacyandPolicy,GlaxoSmithKline

IdaSim,Co-DirectorofBiomedicalInformatics,UCSF

KenjiTakeda,SolutionsArchitect,Microsoft

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TheMRCTCenter’sDataSharingWorkgroupMembers

GovernanceWorkStream ITWorkStream BusinessModelsWorkStream

Co-Chairs:MRCTCenterWellcomeTrustArnoldFoundation

Co-Chairs:IdaSim(UCSF)BarbaraBierer(MRCT)

Co-Chairs:WellcomeTrustMRCTCenter

TeamMembers:MarkBarnes(MRCTCenter)BarbaraBierer(MRCTCenter)StuartBuck(ArnoldFoundation)MarlaJoBrickman(Pfizer)NinaHill (Pfizer)RebeccaLi(MRCTCenter)NickLingler (DeloitteConsulting)JustinMcCarthy(Pfizer)KrisBolt(MRCTCenter)SandraMorris(Johnson&Johnson)JenniferO’Callaghan(WellcomeTrust)NicolaPerrin(WellcomeTrust)PaulSeligman(Amgen)IdaSim(UCSF)JessicaScott(GlaxoSmithKlein)Catrin Tudur Smith(UniversityofLiverpool)NatalieZaidman (Pfizer)

TeamMembers:GeorgeAlter(UofMichigan)Munther Baara (Pfizer)BarbaraBierer(MRCTCenter)KrisBolt(MRCTCenter)BrianBot(SageBionetworks)AnneClaiborne(IOM)KhaledElEmam (UofOttawa)Ghassan Karam (WHO)SeanKhozin (FDA)RebeccaKush(CDISC)RebeccaLi(MRCTCenter)GeneLichtman (HCRI)MichelleMancher (IOM)ChrisMavergames (Cochrane)EricPerakslis (Takeda)FrankRockhold (Duke=)

TeamMembers:BarbaraBierer(MRCTCenter)PatrickCullinan(Takeda)RebeccaLi(MRCTCenter)PeterLyons(Deloitte)KrisBolt(MRCTCenter)NicolaPerrin(WellcomeTrust)Rohin Rajan (Deloitte)

VivliProjectExternalAdvisoryCommittee

• JoeRoss(Yale)

• MartinMurphy(CEORoundtableonCancer)

• MarthaBrumfield(CriticalPathInstitute)

• JanePerlmutter (GeminiGroup)

• SharonTerry(GeneticAlliance)

• JacquesDemotes(ECRIN)

• ScottMcGoohan (BIO)

• JocelynUlrich(PhRMA)

• BenRotz (CSDR)

• Vasee Moorthy (WHO)

• HowardBauchner (JAMA)

• EricPeterson(DCRI)

• MonicaBertagnolli (Dana-Farber)

• MarkWilson(Cochrane)

• BenGoldacre (CentreforEvidence-BasedMedicine)

• Purvish Parikh(AsianInstituteofOncology)

• DavidVulcano (HCA)

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Discussion&

Thankyou

ExampleofNewSearchFunctionality

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