Alphabet Soup: Trial Funding and Support Mechanisms and ......Integrated System (7) Small Network...

transcript

Worta McCaskill-Stevens, M.D., M.S.Director, NCORP

Chief, Community Oncology and Prevention Trials Research GroupDivision of Cancer Prevention

AlphabetSoup:TrialFundingandSupportMechanismsandHowtoUseThem

WithintheAllianceNCICommunityOncologyResearchProgram

(NCORP)May11,2017

DriversBiology

Technology

Economic and Demographics

New Generation of Clinical Trialsand Related Research

ChallengestothePhysician-ScientistTeam

• Demandforoncologyservicesisexpectedtoriserapidly,drivenbyaging,growthofthepopulationandimprovementsincancersurvivalrates

• Theoncologyworkforceisagingandretiringinincreasingnumbers

• Demandisexpectedtorise48%between2005and2020.Thistranslatesintoashortageof9.4to15.0millionvisits,or2,550to4,080oncologists—roughlyone-quartertoone-thirdofthe2005supply.

Clese Erikson,JOP2007

BiomedicalWorkforce(BMW)WorkingGroupJune2012ReportRecommendation

• Differenteconomicandeducationaldriversaffectthetrainingandcareerpathsofthephysician-scientistworkforcethanthePhDworkforce

• Changinglandscapeofhealthcareanditseffectsonacademicmedicalcenterswillaffectfuturephysician-scientistworkforce

ChargetothePhysician-ScientistWorkforce(PSW)WorkingGroup

• DevelopapproachesthatcaninformdecisionsaboutthedevelopmentoftheU.S.PSW

• AnalyzethesizeandcompositionofthePSW;considerimpactofNIHfundingpolicies

• AssessneedsandcareeropportunitiesforPS

• IdentifyincentivesandbarrierstoenteringthePSW

TrialFundingandSupportMechanismsToday’sDiscussion

• Overview:NCORPthroughyear3

• FundingofTrials/StudiesØNCORPResearchBasesØNCORPCommunity&Minority/UnderservedSitesØNon-NCORPResearchBaseMembers

• OtherNCIResources

BriefNCORPOverview

NCORP:3Components

Research Bases• Design and conduct multi-center trials in cancer

prevention, control, screening and post-treatment surveillance clinical trials and cancer care delivery studies

• Provide scientific and statistical leadership• Data management, administration, regulatory

compliance

Community Sites• Accrue participants to

NCORP trials/studies (may include providers, organizations) and to NCTN treatment/imaging trials

Minority/Underserved Community Sites• Accrue participants to NCORP

trials/studies (may include providers, organizations) and to NCTN treatment/imaging trials

• Communities are composed of 30% Minority/Underserved

NCICommunityOncologyResearchProgram(NCORP)isanAcademic/CommunityPartnership

ClinicalTrialsforprevention,control,health-relatedqualityoflife,comparativeeffectiveness,andscreening

• 7,527patientsinYear1and2combined(includesenrollmentstoQOLsub-studiestoTreatmentTrials)

Accrual toNationalClinicalTrialsNetwork(NCTN)treatmentandimagingtrials

• 6,742patientsinYear1and2combined

Cancercaredeliveryresearch focusedonpatient-providerandorganization-levelinfluencesoncanceroutcomes

Incorporationofcancerdisparitiesresearch intoclinicaltrialsandcancercaredeliveryresearch

• WakeForestU:ImprovingResectionRatesAmongAfricanAmericanswithNSCLC

• Earlyonsetmalignanciesin6cancerinracial/ethnicpopulations₋ Breast,colon,prostate,renal,liver,multiplemyeloma

• Expandeddemographicandaccrualdata:DCP001

PrecisionMedicineNCTNTrials:ALCHEMISTAccrualasof4/28/17

Accruals by Organization Type (Swim Lane)

Swim Lane

A151216

% of A151216

ptsA081105

% of A081105

ptsE4512

% of E4512

EA5142 pts

LAPS 461 25% 25 24% 9 26% 21 21%

NCORP 705 38% 39 38% 16 46% 40 41%

ROSTERED 692 37% 40 38% 10 29% 37 38%

Name Accrual

Kaiser Permanente NCI Community Oncology Research Program

Michigan Cancer Research Consortium NCORP 61

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Georgia NCI Community Oncology Research Program 50

Metro-Minnesota NCI Community Oncology Research Program 44

Catholic Health Initiatives NCORP 42

Heartland Cancer Research NCORP 41

Pacific Cancer ResearchConsortium NCORP 29

Main Line Health NCORP 27

Wichita NCORP 21

Stroger Hospital of Cook County Minority Underserved NCORP 19

Baptist Health System/Mid South Minority Underserved NCORP 15

NCORPCommunitySite,MUCommunitySiteandResearchBasesGeographicandOrganizationalDiversity

• Investigators(4,025)• Components/Subcomponents(938)

Community Sites (34)Distributed network (25)Integrated System (7)Small Network (2)

MU Community Sites (12)Academic (8)Non-Academic (4)

Research Bases (7)Research Bases

FundingMechanisms

NCORPStudyandEnrollmentFunding

LAPS,MainMembers,Affiliates,etc.PercasereimbursementfromResearchBasegrant

Concept&ProtocolDevelopment

ReimbursementforPatientEnrollments

NCORPCommunitySitesAnnualgrantawardfundscoverenrollments

FundingfromNCORPResearchBaseGrant

• StudyDevelopment• StatisticalSupport• CommitteeSupport• DataSafetyMonitoringCommittee(s)• Auditing• DataAnalysis

Investigator-Initiated Grants in NCORP

• Must be conducted via the Research Base

• Federally grants are reviewed at the protocol level

• Non-Federally funded grants are reviewed at the concept level

• NCI has recently released guidance for the following:ØTime-line from grant approval to submission of protocolØStrategies to obtain feasibility and level of interest input from

NCORP community and academic investigators

FeasibilityofOmega-3SupplementationforCancer-RelatedFatigue(Peppone,R03CA175599)

PrimaryAims:1) Collectpreliminarystatisticaldata(meanchanges

&standarddeviations)ontwoOmega-3supplementationsvs.placeboforreducingCRF

SecondaryAims:1) Determineadherenceandadverseevents,and2) Collectpreliminarystatisticaldataonpossible

mechanismsofactiontoinformthedesignoffuturetrials

URCC13091– NIHfundingwasneededtopurchasetheagent

S1415CDAPragmaticTrialtoEvaluateaGuideline-BasedColonyStimulatingFactorStandingOrderInterventionForFebrileNeutropenia

PrimaryAim:TocomparetheuseofprimaryprophylacticcolonystimulatingFactoraccordingtorecommendedclinicalpracticeguidelinesamongptsregisteredatinterventioncomponentsvs.usualcarecomponentsSecondaryAims:Todeterminetheneutropeniarateamonglowriskpatients

PCORIFunding

A221505:PhaseIIIRandomizedTrialofHypofractionatedPostMastectomyRadiationwithBreastReconstruction

PrimaryObjective:Toevaluatewhetherthereconstructionthecomplicationrateat24mos.postradiationisnoninferior withhypofractionationcomparedtostandardfractionation

SecondaryObjective:Toevaluatetheincidenceofacuteandlateradiationcomplications

UseofIROC– mechanism- supplementtoNCTNU-24

BIQSFPFunding

• Goal:EnhancethescientificqualityofNCI-fundedclinicaltrialsbyimprovingprioritization,fundingandstandardizationofassociatedbiomarkerandqualityoflifestudies

• Initiative1:Assurethatadequatefundingisavailableforclinicaltrialsinvolvingbiomarkers,imaging,andqualityoflife

• Initiative2:EstablishqualitycontrolstandardsforlaboratoryassaysandimagingproceduresusedinassociationwithNCI-fundedclinicaltrials

2017Eligibility

• NCTNGroupsandNCORPResearchBases

• Phase2(≥100patients)and3treatmentclinicaltrialswithintegralorintegratedbiomarkerorimagingorQOL/PROstudies

• Phase3CancerPreventionclinicaltrialswithintegralorintegratedbiomarkerorimagingstudies

• RandomizedSymptomSciencetrialswithefficacyendpoints

• Cost-EffectivenessAnalysis(CEA)studies:randomizedphase3treatmentorpreventionclinicaltrialwithacomparatorarmorasymptomscience/supportivecareclinicaltrialwithacomparatorarm.

Funding&Review

NCORPLaunchtoPresent:AccrualSuccesses

A221303:EarlyPalliativeCarevsStandardOncologyCare

• 400+patients

Alliance221304- PhaseIIIPlacebo-Controlled,RandomizedThree-ArmStudyofDoxepinandaTopicalRinseintheTreatmentofAcuteOralMucositisPaininPatientsReceivingRTwith/withoutChemotherapy

• 272patientsECOG/ACRIN4112– ProspectiveStudyofMagneticResonanceImagingandMulti-parameterGeneExpressionAssayinDCIS

• 362patients

AdditionalNCIResources

NCIResources

• NCORPProgramDirectors

• DianeSt.GermainandImanMartin

• CoverageAnalysisandPartnershipwithCMS

• NCORPCCDRLandscapeData

• NCORPwillhavetrialspecificdataaboutaccrual(Log)

• https://ncorp.cancer.gov/

Summary from NCI DCP Cancer Prevention Think Tank Published in AACR Cancer

Prevention Research

WorkingGroups

RadiationOncology

AdolescentandYoungAdult

Non-OncologySpecialists

DisparitiesIntegration

Non-Oncology Specialists WG GOALS

• Create and share strategies to engage primary care physicians and other non-oncology specialists (e.g. gastroenterologists, gynecologists, primary care practitioners) and connect with organizations (e.g. NMA, AAFP, etc.)

• Support these connections with researchers and other relevant organizations

• Invite member representatives from these organizations to act as champions for cancer prevention research trials across their organizations.

Thankyou!

SCConcept&BIQSFPReviewandApproval:

GenesisofaProtocol

Concept Approval S.C.

3-monthdeadline

Study Team/Research Basedevelops protocol

responding to outstanding issues from the concept

reviewSubmits to DCP

FDA submitin parallel if applicable

DCP reviewsSends response

Approve, Revise/resubmit,disapproval

Central IRB ReviewProtocol is

activated byresearch base

2-month deadlineRevise, responding to

review commentsSubmit to DCP

FDA finalizationIntervention prep Revise &

ResubmitApprove CIRB activate

Unlimited times, can also be disapprovedAccrue!

Delays can occur from:CIRB review pendingCIRB requested

changes

Integrative BIQSFP submitted and reviewed by SC

*Integral BIQSFP submitted and reviewed by SC along with initial concept and concept revisions

EvaluationofNCORPResearchConcepts

• Theconceptisthemostimportantdocumentfromwhichthescientificmeritforanideaisevaluated

• Allconceptsarereviewedinternally

• NCIhasaSteeringCommittee(SC)reviewprocessfordiseaseandnondisease concepts

• FollowingaconceptapprovalbyaSC,theprotocoldevelopmentismanagedinternally

NCORPConceptReview

ConceptReceivedinProtocolInformationOffice

SteeringCommitteeReviewor

InternalReview

DCPInternalReview

Chairperson,ReviewersandPIOTeamMedicalOfficersNurseConsultantsDCPBiometryExpertsfromDCCPS,DCTD,CRCHDOtherExpertise:NIH,NCICCR,

ExtramuralCommunity

• SymptomManagement&QOL• CancerCareDelivery• ClinicalImaging• Breast

NCICoordinatingCenterforClinicalTrials:ScientificSteeringCommittees

ConceptEvaluationProcess

SteeringCommitteeEvaluationofConcept

Approval

Concept may be revised &

submitted once

ProtocolDevelopmentbyResearchBase

ConsensusReview

Revise&ResubmitPendingDisapproval

WhatDoesNotGototheSteeringCommittees?

• Longitudinalstudies,surveys,cancerprevention

• Pediatriccancercontrol

• Studies≤100participants

• ResearchstudiesforwhichthereisnoestablishedscientificSC

• Studiesreviewed&fundedbyFederalAgencies– InvestigatorInitiatedStudiesarereviewedattheprotocollevel

• Phase0and1Trials

ProtocolReview

• Includesallinformationandproceduresnecessaryforconductingasuccessfultrial/study

• AssessesINDstatus,credits,rosters,accrualplans,non-federalfunding

• Evaluatestheinclusionofscientificinputfromtheconceptreview

ProtocolEvaluationProcess

DCPProtocolCommitteeEvaluation

Approval

Disapproval Revise&ResubmitPending

Approval“onHold” ConsensusReview

CTSUReview&RBActivation

Investigator Initiated Grants§ Must Come through the Research Bases

§ Reviewed at the Protocol Level

§ No phase III RCTs for Prevention

Theworldwecreatedtodayhasproblemswhichcannotbesolvedbythinkingthewaywethought

whenwecreatedthem…..AlbertEinstein

3860640276

3531836672

32317 33021

3037932309

8374 91847409 7460 7559

900511572 10652 9935 10210 10423

FY2003 FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011 FY2012 FY2013

Majority Minority Unknown

MinorityEnrollmenttoNCICooperativeGroupClinicalTrials

14% 16%17% 16% 17% 17%

19% 20% 19%21%17%

85% 83%82% 83% 82% 81%

79% 78% 79%77%81%

Alphabet Soup: Trial Funding and Support Mechanisms and ......Integrated System (7) Small Network...

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