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