CORE Reference Clarity and Openness in Repor4ng: E3-based

3yearson-aresourceforCPD

Vienna 7 – 11 May 2019

DrSamHamilton–ChairDrArtGertel–Strategist

10May2019

RECAP: What Is CORE Reference? 1.COREReference(PDF)•  Preface(21pages,references+assumpKons)

•  Mainbodytext(103pages)•  ICH(E3and2012Q&A)guidancetext•  EUandUSregionalguidances•  COREReferencetext

•  DisKnguishedviashadingand•  IncludesexplanaKonsofCOREReferenceclarificaKons

2.Mappingdocument(PDF)•  ICHE3 COREReferencesecKonalstructure3.ExplanaKonandelaboraKonpaperpublishedinapeer-reviewedjournal

HamiltonS,etalResearchIntegrityandPeerReview2016

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3 Years On: Project Evolu4on • www.core-reference.orgacKveandresource-richwebsite:

ESTABLISHEDRESOURCES•  DownloadablePDFsofCOREReference+MappingTool(counters)•  MulKplepublicaKonswithdirectlinks

CONTINUINGPROFESSIONALDEVELOPMENT•  In‘realKme’clinicaltrialdisclosure-relatednewsdirecttoyourinbox

•  h\ps://www.core-reference.org/subscribe•  Periodic‘NewsSummaries’dedicatedpage•  Externallinks:Japaneselanguageblog,TransCelerateCSRtemplate•  LinkstoEMA,FDA,HealthCanadadisclosureregulaKonsandportals

CPDCPD

CPD

CPD

Finding CORE Reference h\p://www.equator-network.org/reporKng-guidelines/core-reference/• PROBLEM:NOTeasilyfindablethrougha‘guidelinessearch’•  SOLUTION:EQUATORadded60+keywordstoourentrytoaidsearchretrieval(March19)

External Resource Development • h\p://www.transceleratebiopharmainc.com-anallianceamong“someoftheworld’sprominentbiopharmaceuKcalorganizaKons”…“acceleraKngthedevelopmentofnewmedicines”.TransCelerateprovidesoluKonsthat“…aredevelopedcollaboraKvelyandcanbevoluntarilyadoptedbystakeholdersintheclinicalresearchecosystem”TransCelerateCSRtemplatedevelopedNovember2018

•  TransCelerateCSRtemplateisindependentfromCOREReference

BUT…servessimilaraims

TransCelerate CSR Template •  TheCSRtemplateandstaKsKcalanalysisplan(SAP)templates–areunderthe“CommonProtocolTemplate”resourcesat:h\p://www.transceleratebiopharmainc.com/assets/common-protocol-template/

•  ICHE3andCOREReferenceareconfirmedasthetwo“well-knownstandards”usedindevelopmenth\p://www.transceleratebiopharmainc.com/wp-content/uploads/2018/11/CPT_ImplTK-How-was-Common-CSR-Developed_V001.pdf

• BudapestWorkingGroupiniKalobservaKons:PressReleaseDec18h\ps://www.core-reference.org/news-summaries/core-reference-statement-on-transcelerate-csr-template/

Reasonable Ques4ons Arising…

• WasICH,oraregionalregulator,ortheBWGinvolvedinthedevelopmentoftheTransCelerateCSRtemplate?

• DoestheTransCelerateCSRtemplateaccuratelyreflectICHE3guidanceandCOREReferencerecommendaKons?

• DotheTransCelerateCSRtemplateandCOREReferencecomplementeachotherastoolstofacilitatecompliancewithICHE3?

• Whichresource(s)shouldMWsnowusetowriteCSRs?• WhatnextforCOREReference?

THESEAREALLGOODQUESTIONSTHATNEEDTOBEADDRESSED…

BWG’s Detailed Review of TransCelerate CSR Template

• ReviewedMar-Apr2019byBWG:SH,AG,TF,VF,AB,WS,GB• CommunicaKonwithglobalclinicalresearchcommunity

•  Targetopen-accessjournal:“ResearchIntegrityandPeerReview”

• Manuscriptcontents:•  KeyfindingsandrecommendaKons(Table1)

•  Detailedline-by-linereviewofCSRtemplate;consolidatedcomments(Appendix)•  Version2.0oftheCOREReferenceTerminology(Table2)

BWG’s Well-Considered “Answers” • WasICH,oraregionalregulator,ortheBWGinvolvedinthedevelopmentoftheTransCelerateCSRtemplate?Wedonotbelieveregulatorswereinvolved;BWGwerenotinvolved

• DoestheTransCelerateCSRtemplateaccuratelyreflectICHE3guidanceandCOREReferencerecommendaKons?AddiKonalinstrucKonaltextwouldaddvalue

• DotheTransCelerateCSRtemplateandCOREReferencecomplementeachotherastoolstofacilitatecompliancewithICHE3?Yes;bothofferdifferentvalue

• Whichresource(s)shouldMWsnowusetowriteCSRs?Allavailable• WhatnextforCOREReference?Version2.0isnolongerforeseen.www.core-reference.orgisaresourcefor CPD

Planned Publica4on

• ReviewoftheTransCeleratetemplateforclinicalstudyreports(CSRs)bythedevelopersofCOREReference(ClarityandOpennessinReporOng:E3-based)

• HamiltonS,BernsteinAB,BlakeyG,FaganF,FarrowT,JordanD,SeilerW,GertelA

•  Submi\ed07May2019

• OnpublicaKon,wewillsharetheopen-accesslinkwidely;pleasehelpus-forwardthelinktoyourcolleagues

THANKYOU