Alliance Organizational Structure
Trini Ajazi, MMAlliance Chief Administrative Officer
Clinical Research Professional Orientation
May 10, 2017
NCI-NCTN• NationalCancerInstitute(NCI)NationalClinicalTrialsNetwork(NCTN)isaconsolidated,integratednetworkcomprisedoforganizationsthatconductdefinitive,randomizedclinicaltreatmenttrialsacrossabroadrangeofdiseasesanddiversepatientpopulations
• 4AdultNetworkGroups,1Canadianand1PediatricGroupthatsponsorandleadNCTNtrials
NCORP• NCICommunityOncologyResearchProgram(NCORP)– communitybasedprogramdesignedtobringclinicaltrialstoindividualsintheirowncommunitiesandcontributetoimprovedpatientoutcomesandreductionincancerdisparities
• NCORPdesignsandconductscancerprevention,control,screening,postsurveillanceandcancercaredeliveryclinicaltrials
• FacilitatesaccesstotreatmentandimagingtrialsfromNCTN
About the Alliance for Clinical Trials in OncologyNational Clinical Trials Network (NCTN) Group consists of nearly 10,000 cancer specialists at approximately 1000 hospitals, medical centers, and community sites across the United States and Canada.
Vision: to reduce the impact of cancer by uniting a broad community of scientists and clinicians from many disciplines, committed to discovering, validating and disseminating effective strategies for the prevention and treatment of cancer
Alliance MissionAlliance achieves its purpose by
conducting high quality multidisciplinary cancer control, prevention, and treatment trials that engage a
comprehensive research network;
furthering our understanding of the biological basis of the cancer process and its treatment, from discovery, to
validation, to clinical practice;
providing a scientific and operational infrastructure for innovative clinical and translational research in
academic and community settings
AllianceHistoryMergerofthreeGroups11bythemergerofthreecooperativegroups:• AmericanCollegeofSurgeonsOncologyGroup(ACOSOG)• CancerandLeukemiaGroupB(CALGB)• NorthCentralCancerTreatmentGroup(NCCTG)• Merger initiated in 2011 and completed March 2014
with start of new NCTN grant period
• ThemergerofthesecooperativegroupsreflectsthecallinApril2010fromtheInstituteofMedicine(IOM)tostrengthenandstreamlineoperationsamongNCIclinicaltrialscooperativegroupprograms.
AllianceNetworkMembership
• InstitutionsmustmeetAllianceaccrualandperformancerequirementsperAlliancePoliciesandProcedures
• Membersareacademicandcommunitysites,includingNCIgrantfundedLeadAcademicParticipatingSites(LAPS)andNCICommunityOncologyResearchProgram(NCORP)sites
• MoststudiesareavailabletoallNCTNmembersitesviaanopenmenu
Alliance: Overview of Governance and Program Structure
Alliance Board of Directors
Alliance Group Chair
Director, Statistics & Data Management Program
Group Vice Chair
Director, Central Protocol Operations Program
Director, Translational Research Program
Director, Cancer Control Program
Chief Administrative Officer
Director, ACS Clinical Research Program
Chief Financial Officer
Executive CommitteeThe primary governance body of the Alliance is the Board of Directors, which represents the group’s institutional members.
The Alliance is led by the group chair with assistance from the group vice chair. The Alliance is also
supported by five program directors, each responsible for a specific program integrating discipline-related science and operational functions across all disease committees.
The Executive Committee represents the Board of Directors and assists the group chair in planning and coordinating group activities.
Leukemia LymphomaRespiratoryGenito-urinary
Gastro-intestinalBreast MyelomaNeuro-
Oncology
ScientificModality/Disciplines
SurgicalOncology,ResearchProgram,Transplant,RadiationOncology,Pathology,Imaging,OncologyNursing,ClinicalResearchProfessionals,Biostatistics,Bioinformatics,
Pharmacology,Pharmacogenomics,PatientAdvocates,HealthOutcomes,SymptomIntervention,ExperimentalTherapeutics,
CommunityOncology,ResearchEthics,LaboratoryMedicine,CancerPrevention,CancerCareDelivery,YoungInvestigators,Pharmacy
AdministrativeCommittees:BoardofDirectors,ExecutiveCommittee
ConstitutionandBylaws,Membership,InstitutionalPerformanceEvaluation,ConflictofInterest,Audit,Publications,
DataandSafetyMonitoringBoard
AllianceLeadership• GroupChair:MonicaBertagnolli,MD,Dana-Farber/BrighamWomen’sHospitalCancerCenter
• GroupViceChair:SuzanneGeorge,MD,Dana–FarberCancerInstitute
• GroupStatistician/DirectorSDMP:SumithraMandrekar,PhD,MayoClinic
• Director,CentralProtocolOperationsProgram:GiniFleming,MD,UniversityofChicago
• Director,CancerControlProgram:JanBuckner,MD,MayoClinic• Director,TranslationalResearchProgram,FraserSymmans,MD,MDAndersonCancerCenter
• DirectorAmericanCollegeofSurgeonsClinicalResearchProgram:KellyHunt,MD,MDAndersonCancerCenter
BoardofDirectors
lComprisedof50AlliancePrincipalInvestigatorsorinstitutionalrepresentative
lResponsibleforfinalapprovalofoverallpolicyfortheAlliance,electionofGroupChair,approvalofinstitutionalmembership.
lExecutiveCommitteereportstotheBoardofDirectors
ExecutiveCommitteelLedbyGroupChairandGroupViceChairlMembersincludethe5 programdirectors/co-principalinvestigatorsand4academicBODrepresentativesand4communityBODrepresentatives
lRecommendstotheBoardofDirectorsoverallAlliancepolicy,direction,priorities,andactivities
lApprovescommitteechairandvicechairappointments
OfficeoftheGroupChair
• GroupAdministration• Finance•MembershipServicesandCommunications• RegulatoryComplianceandQuality Assurance
OperationsUnits(locatedatBWHand
UChicago)
• Breast,Gastrointestinal,Genitourinary,Leukemia,Lymphoma,Myeloma,Neuro-oncology,Respiratory,Transplant
• PatientAdvocates,ClinicalResearchProfessionals,ExperimentalTherapeutics,OncologyNursing,RadiationOncology
ScientificCommittees
• Audit,PatientCommunications,ConflictofInterest,Constitution,DSMB,Ethics
• YoungInvestigators,InstitutionalPerformanceEvaluation,Membership,Pharmacy,Publications
AdministrativeCommittees
Group Chair and Principal Investigator: Monica M. Bertagnolli, MD - Dana-Farber/Brigham and Women’s Cancer CenterGroup Vice Chair: Suzanne George- Dana Farber Cancer Institute
StatisticsandDataManagement
••DataManagement••SystemsManagement••InformationSystems••Statistics
••Biostatistics••Bioinformatics
OperationsUnits(locatedatMayoandDuke)
ScientificCommittees
GroupStatisticianandPrincipalInvestigator:Sumithra Mandrekar,PhD- MayoClinicOperationsManager:Cari Cummins– MayoClinic
CentralProtocolOperations
••ProtocolOffice(ProtocolDevelopmentandManagement)••PharmaceuticalAffairs
••StudyConceptReview
OperationsUnits(locatedatUChicago)
ScientificCommittees
PrincipalInvestigatorandDirector:GiniF.Fleming,MD- UniversityofChicagoDirectorofProtocolOperations:MichaelKelly,MA,UniversityofChicago
TranslationalResearchProgram
• IntegratedBiorepositories• TranslationalResearchOperations
OperationsUnits(locatedatMS
Anderson, Uchicago,WashU)
• LeukemiaCorrelativeSciences,SolidTumorCorrelativeScience,Imaging,Pharmacogenomic &PopulationPharmacology,Pathology,Sequencing
ScientificCommittees
• Karotype Review,BiorepositoriesAdministrativeCommittees
PrincipalInvestigatorandDirector:W.FraserSymmans,MD,MDAndersonCancerCenterDirectorBiorespositories:MarkWatson,MD,WashingtonUniversityDirectorTranslationalResearchOperations:Yujia Wen,PhD,UniversityofChicago
CancerControlProgram
••NCORPResearchBase
••CancerintheElderly,HealthDisparities,HealthOutcomes,Prevention,SymptomIntervention
••CommunityOncology(Administrative)
OperationsUnits(locatedatMayo)
ScientificCommittees
PrincipalInvestigatorandDirector:JanC.Buckner,MD- MayoClinicProgramManager:JacquelineLafky,MS– MayoClinic
ACoS ClinicalResearchProgram
• CommissiononCancer• NationalCancerDatabase• ProgramManagement
OperationsUnits(locatedatMD
Anderson/ACS Chicago)
• CancerCareStandardsDevelopment• CancerCareDeliveryResearch• Dissemination andImplementation
ScientificCommittees
•EducationAdministrativeCommittees
PrincipalInvestigatorandDirector:KellyHunt,MD,MDAndersonCancerCenterProgramManager:AmandaFrancescatti,MS,AmericanCollegeofSurgeons
Alliance for Clinical Trials in Oncology Foundation
Not-for-Profit Corporation created to enhance and expand the ability of Alliance members* to conduct cancer clinical research
• 501(c)3• Governance and operations structure separate from the Alliance
Alliance Foundation Trials, LLC (AFT)• LLC (sole member = Foundation) created to conduct cancer clinical
research involving partners other than the National Cancer Institute
ALLIANCE NCTN/NCORP
Study Design by Scientific and
Modality Committees
Study Operations
OrgCharts
GroupChairMonicaBertagnolli,MD
ChiefFinancialOfficerDeniseBrennan
GrantsAdministration
Finance
MeetingsManagement
ChiefAdministrativeOfficerTrini Ajazi,MM
AdministrativeSupport/OfficeManagement
MemberServices
IT/IS RegulatoryAffairsandCompliance
ProjectManagement
QualityAssurance/Audit
Program
Communications Training
Reporting
GroupVice-ChairSuzanneGeorge,MD
Office of the Group Chair
PrincipalInvestigator/DirectorGiniFleming,MD
ExecutiveOfficersLindaSluman,MDSelinaChow,MD
PriyaKumthekar,MD
PharmaceuticalAffairsManager
LigiMatthews,PharmD
DirectorTranslationalResearchOperations
YujiaWen,PhD
DirectorProtocolOperations
MichaelKelly,MA
ProtocolInformationSpecialist ClinicalTrialManagers
ProtocolCoordinators SeniorProtocolCoordinators
Central Protocol Operations Program
AdditionalSlides– ProgramStructuresandOrgCharts
TranslationalResearchProgram(TRP)
BiorepositorySystems
SpecimenTracking
TissueCollection
TissueStorage
TissueProcessing
InformationTechnology
TRPAdministrative
Core
MolecularReferenceLaboratories
IHC/FISH/PCR
Microarray
SerumProteomics
Pharmacokinetics
Pharmacogenomics
Sequencing
TRPScientificAdvisoryBoard
TRPExecutiveCommittee
BiorepositoryCommittee
ImagingCommittee
KaryotypeReview
LeukemiaCorrelativeScienceCommittee
PathologyCommittee
PharmacogenomicsandPopulationPharmacology
SequencingCommittee
Alliance/American College of Surgeons
Clinical Research Program
Executive Committee
Scientific Committees
Cancer Care Delivery Research
Dissemination & Implementation
Cancer Care Standards
Development
Administrative Committee
Education
Alliance/American College of Surgeons Clinical Research Program Committee Structure
ProgramDirector,ClinicalResearch
Program
Manager,ClinicalResearchProgram
ProjectManagerDeveloper
Alliance/American College of Surgeons Clinical Research Program Staff Structure
President
ChiefAdministrative
Officer
QualityandCompliance
QASupport
ChiefFinancialOfficer
Accounting
AccountingSupport
Budget&FiscalPlanning
ChiefOperatingOfficer
AdministrativeSupport
HR/OfficeManagement
IT/ISRegulatory&Protocol
Management
ProjectManagement ProjectSupport
Sr.SiteManagement
SiteSupport
Contracts&Agreements
ContractSupport
VicePresidentChiefScientificOfficer
AFT Operations Structure
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