Barbara E. Bierer, MD [email protected] September 28, 2016 · 2016. 9. 28. · GSK Lilly Takeda...
Transcript of Barbara E. Bierer, MD [email protected] September 28, 2016 · 2016. 9. 28. · GSK Lilly Takeda...
Datasharingandtransparency:theroleofdatastandards
BarbaraE.Bierer,[email protected]
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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