PhUSE Annual Conference, Barcelona 11. October 2016 Jean … · 2016-11-04 · Jean-Marc Ferran...
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PhUSE Annual Conference, Barcelona 11. October 2016 Jean-Marc Ferran Consultant & Owner
Transcript of PhUSE Annual Conference, Barcelona 11. October 2016 Jean … · 2016-11-04 · Jean-Marc Ferran...
PhUSEAnnualConference,Barcelona11.October2016Jean-MarcFerran
Consultant&Owner
Source:EMAUpdate,Sweeney&Alteri,CDISCEuropeanInterchange,Vienna,27April2016
• StudyResultsPublicDisclosureOverview
• EudraCTandClinicalTrials.govProcesses
• Policy0070AnonymizaRonGuidanceOverview
• Conclusions
USPublicDisclosureDatabase
EUPublicDisclosureDatabase
Policy0070PartAPartB
StudyResultsEffecRveSEP2008
StudyResultsEffecRve20JUL14
CSREffecRve01JAN15
IPDEffecRve???
AnyStudypartofanapprovedINDapplicaRon
AnyStudywithsitesinEurope(EEA)&StudiesinChildren
conductedoutsideEUbutpartofaPIP
AnyStudypartofaCentralizedMarkeRng
AuthorizaRonapplicaRon
???
InformpublicandtrialparRcipantsoncore
Results
InformpublicandtrialparRcipantson
coreResults
Understandconclusions
Conductsecondary-
purposeanalyses,reviewdataorverifyresults
5
LPLV
Approval
Approval+30daysLPLV+6/12months
INDnotapprovedatstudycomple>on
LPLV+6months LPLV+12months
LPLV
INDapprovedatstudycomple>on,Pediatricstudy
LPLV+12months
LPLV
INDapprovedatstudycomple>on,Adultstudy
Source:haps://www.clinicaltrialsregister.eu/ctr-search/trial/2012-003699-37/results
TrialInformaRon
Purpose
SubjectDisposiRon
SubjectDisposiRon
PaRentFlow
BaselineCharacterisRcs
BaselineCharacterisRcs
MoreInformaRon
MoreInformaRon
Non-SeriousAE
SeriousAE
SeriousAE OtherEvents
EndPoints
OutcomeMeasures
PresentaRonRtle Date 8
Input
SASCode
Output
ADSLADAE
EUTCTSOC
CODES
AEStatistics
AgeCategoryStatistics
CountryStatistics
AESummaryReport
AEXMLAge
CategoryReport
CountryReport
CSR
EudraCTReport
• TrialInformation• SubjectDisposition• BaselineCharacteristics• Endpoints• MoreInformation
• AdverseEvents
• TrialInformation
• TrialInformation
10
11
12
?Input
SASCode
Output
ADaM
PublicDisclosureXML
TrialInfo.Reports
PublicDisclosure
ManagementSystem
CSR
AnalysisResults
Metadata
SummaryResults
BaselineCharact.Reports
SubjectDispositionReports
EndPointsReports
AESummaryReport
CSR
• TrialInformation• SubjectDisposition• BaselineCharacteristics• Endpoints• AdverseEvents
• MoreInformation• Verifyotheruploaded
sections
StudyMetadata
Source:EMAUpdate,Sweeney&Alteri,CDISCEuropeanInterchange,Vienna,27April2016
• CDISCCTR-XMLSpecifica>on,version1.0releasedon28MAR2016• ClinicalTrialregistrysubmissionstoWHO,EudraCTregistryandClinicalTrials.GOV
• ProtocolschemathatcanbeimplementedinSofware• HarmonizaRonwithTransCelerateprotocolwork
• Summaryresultsdataelements• CollaboraRonwiththePhUSERDFWorkingGroup
Source:CTRUpdate,PaulHouston,CDISCEuropeanInterchange,Vienna,28April2016
SponsorsPublica>ons
SponsorsDataTransparency
Ini>a>ves
Policy0070PartAPartB
BasedonPseudomizedIPD
Forever…
AnonymizedIPDStartedin2013withGSK
AnonymizedCSRPortalgo-liveSEP2016
AnonymizedIPDEffec%ve???
Sponsors’choice AnyStudyrelatedtoanapprovedapplicaRon
inEU&US
AnyStudypartofaCentralizedMarkeRng
AuthorizaRonapplicaRon
???
NoAnonymizaRon Safe-HarbororAverageRiskMetrics
QualitaRveorMaximumRiskMetrics
AverageorMaximumRisk
Metrics?
PublicDomain MayresultinPublicaRonsavailableinPublic
Domain
Semi-PublicDomain PublicDomainorControlled?
PublicaRonsavailableinPublicDomain
Guidance2.March2016
NarraRvesmustbeanonymized
LisRngsnotinscopeofPartA
RecommendsusingthePhUSEDeIDstandard
FocusonDataURlitymustbedemonstrated
AnonymizaRonReportismade
public
SponsorremainsDataController
AvailablePublicDataand
Technologymayevolve
Conclusionsmustbesimilar
Pseudomized&Derived
Pseudomized Pseudomized
ADaM
SDTM+Raw
SDTM
Pseudomized&Aggregated
ScientificCSR
Pseudomized
SafetyDatabase
Listings
TFLs
Narratives
Anonymized&Derived
Pseudomized Pseudomized
ADaM
SDTM+Raw
SDTM
Anonymized&Aggregated
AnonymizedCSR
Anonymized
SafetyDatabase
Listings
TFLs
Narratives
SelectedTFLs
AnonymizedCSR
(Anonymized)SDTM/ADaM
Risk!(Anonymized)PublicaRon2
Risk?
(Anonymized)CSR
(Anonymized)PublicaRon1
Risk?
PublicDomainRestricted
• CanweexpectRegulatoryAgenciestoalignorevenintegratesuchrequirements?– Probablynotfully…buttosomeextentyes…
• Differentlegalenvironments• Largedifferenceinresources
• Globaldatamodelsforprotocolandresultssummarywillberequiredtoensureinteroperabilityandreuse
• EMACSRAnonymizaRonGuidanceissRllbeinginterpretedbyanumberofindustrygroupsandcompaniesandanumberofsoluRonsshouldemergeinthecomingyear…
Jean-MarcFerranConsultant&Owner,QualianceApSdk.linkedin.com/in/jeanmarcferran/@QualianceTwiaa
