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WilliamBarsan,MDSIRENClinical
CoordinatingCenter
Evolutionnotcreation
Specificaims
1.diligentlyrecruit,efficientlyperform,andwidelydisseminatethemostscientificallyandclinicallyimportanttrialsinemergencypatientcare
2.createacultureofclinicaltrialsthatiscollaborative,multidisciplinary,diverseandinclusivethroughleadership,openness,andengagement
3.transformtheemergencyresearchenterprisethroughinnovativedesign,patientstakeholderengagement,betteroperationalstrategies
Designprinciplesandorganizationalvalues
• Focuson earlytreatment.
• Focusonmeaningfuloutcomesforpatients.
• Focuson efficiency.
• Focuson collaboration.
• Focuson transformingtheclinicaltrialsenterprise.
SIREN Grant Awards
Massachusetts General Hospital
Temple University
University of Pittsburgh
Wayne State University
University of Cincinnati
Emory University
Medical College of Wisconsin
University of Minnesota
University of Washington
Oregon Health Sciences University
University of California Los Angeles
Coordinating Centers
University of Michigan
Medical University of South Carolina
Clinical Trial Summaryand Rough Budget
Trial Ideas(from
anybody)
Scientifically and Clinically Important
Questions and Observations
InstitutePre-approval
to submit
Grant application(s)
Collaborative Grant Application
and Protocol Development with input from Sites,
Patients, and Others
NIH Study Section
Revise Grant Award
Grant Award to Scientific PI’s Institution with
major subaward to CCC
DCC may be paired grant or
subaward depending on IC
Begin discussions with NIH program
officers early
Begin discussions with SIREN leadership early as well.
SIREN leadership will evaluate fit for the network, contribute to concept, and relay to site PI’s
SIREN will NOT be a layer of scientific peer review
TrialRecruitmentandPipeline
AdaptableopenclinicaltrialinfrastructureCollaborativeleadership(typicallymultiplePI)Respectfulofinvestigators’ownershipandcontrolofthescienceSharingofoperationalandstatisticalresponsibilitiesFacilitatingsuccessfulimplementationanddataintegrity
TrialRecruitmentandPipeline
Effectivenessandefficiencyfromconsistentre-useof:establishedskilledresearchteamsandinterpersonalrelationshipspre-existingcontractual,regulatory,administrativeframeworksfamiliarandconsolidatedclinicaltrialmanagementtechnology.
Optimalstrategyforworkingwiththenetworkis:contactpriortorequestingpermissionfromtheinstitutetosubmitcollaborativedevelopmentoftrial,grantapplication,andbudget
ScopeofPortfolio
LatelearningphaseorconfirmatoryphasetrialsPatientorientedoutcomesControlledefficacytoregistrybasedRCTAppropriatesizedforourscalablenetwork
Primaryfocusonneurological,cardiac(lungandblood),(andtrauma?)SecondaryfocusonotherICportfolios,andhealthservices
QUESTIONS?
Innovationsintrialdesign
• Answeringthemostimportantquestionswiththemostappropriatetrialdesignforthatquestion
• AdaptiveDesigns• RegistryBasedRCT’s(AHAandACS/COT)
• GoodTrialDesignAffectsSubject Accrual
OrganizationalStructure
Specimen
Pharmacy
Imaging
Spokes
Hubs
CCC
NIH
DCC
MgmtComm
SteeringComm.
TrialPI
AHAACS
RegistryBasedRCTWG
CriticalCareWG
HSPWG
SurgicalWG
EMSWG
DSMB
Trial Comm
OperationsCommittee
FederalComm.
ER-CIRB
Innovationsintrialoperations
• StudyTeamsAffectTrialSuccess• CreatingaCultureofService• EngagingCommunityStakeholders
IllustrationofgrantrelationshipsinSIREN
Hubsandspokes(designatedbyrectangles)representenrollmentsites.Circlesarecoordinatingentities.
SuperHub SuperHub SuperHub SuperHub
SubHub SubHubSubHub AncillaryHub/Spoke
AncillaryHub/Spoke
TrialPrime
NIH
DCCCCC
Spoke Spoke SpokeSpokeSpokeSpokeSpokeSpoke Spoke SpokeSpoke Spoke Spoke
MultiplePILeadershipPlan- CCC
• Barsan• Silbergleit• Callaway
MultiplePILeadershipPlan- DCC
• Palesch• Durkalski
NIHProgramLeadership
• Brown• Mendoza-Puccini• Sopko• Culp
Keyassets
• People• StreamlinedFinancialManagement•PatientRecruitmentandEnrollment•OutstandingDataManagement
• QualityAssurance
IllustrationofproposedcontractualrelationshipsinSIREN
Hubsandspokes(designatedbyrectangles)representenrollmentsites.Circlesarecoordinatingentities.Dottedlinesrepresentoptionalrelationships.DashedlinesrepresentHub-spokecomplexes.Numberofblue“superhubs”isestablishedbynumberofindividualNIHenrollmenthubawards.SteeringCommitteeincludesall“superhub”PI’s(includingmultiplePI’s)withonlyonevotepersuper-hub.Green“subhubs”areaffiliatedwith“superhubs”buthavetheirownmasteragreementwiththeCCC.Whichsiteswithinahub-spokecomplexare“subhubs”isdeterminedlocally,butaretypicallydistinguishedbythe“subhub”beinganinstitutionthathasitsownspokes.AncillaryHub/spokesaretypicallycontractedbytheTrialPrimeifbroughtonforasingletrial,orbytheCCCifexpectedtoparticipateinmultipletrials(includingthosealreadyparticipatinginmultipletrials).
SuperHub SuperHub SuperHub SuperHub
SubHub SubHubSubHub AncillaryHub/Spoke
AncillaryHub/Spoke
TrialPrime
NIH
DCCCCC
Spoke Spoke SpokeSpokeSpokeSpokeSpokeSpoke Spoke SpokeSpoke Spoke Spoke
IllustrationofproposedcontractualrelationshipsinSIREN
PotentialSourcesofTrials
EarlyreferralsfromprogramofficersatNIHInvestigatorscontactingusdirectlySIRENinitiated/generatedtrials
(addressingneeds,portfoliogaps,ICpriorities)(retreats/workshops)
Industrypartnerships(SBIRs)
EmergencyResearchCentralIRB(ER-CIRB)
Site Site Site Site
CCC
CIRB
ER-CIRB
CTMS WebDCU
IRB-IT
• Closecollaborationwithvendor• Mostlyexistingrelianceagreements• IRBcommunicationallthroughCCC• InfoallsubmittedthroughWebDCU
• Expectsomegoodandsomebad
Outreach
• NetworkCollaborationPECARNPETALLITESStrokeNETOthers
• StakeholderEngagement