Developing Relationships:Developing Relationships:Cooperative Group NetworkingCooperative Group Networking

Kandie Dempsey, MS, RN, OCN, CCRPKandie Dempsey, MS, RN, OCN, CCRPDelaware Christiana Care CCOPDelaware Christiana Care CCOP

Christiana Care Health Services, Inc.Christiana Care Health Services, Inc.Helen F. Graham Cancer CenterHelen F. Graham Cancer Center

ACRINACRINOctober 2, 2008October 2, 2008

GoalsGoalsScope of oncology research activities at the Scope of oncology research activities at the Delaware/ Christiana Care Research Program Delaware/ Christiana Care Research Program (CCOP).(CCOP).– Overview of research programOverview of research program– Mechanisms of success.Mechanisms of success.– Benefits to the State & CommunityBenefits to the State & Community

Discuss collaboration with the CCOP & CALGBDiscuss collaboration with the CCOP & CALGB ..– Overview of CALGBOverview of CALGB– CALGB Clinical Research Associates Committee.CALGB Clinical Research Associates Committee.

– ..

DE Christiana Care CCOPDE Christiana Care CCOP

Funded CCOP since 1987Funded CCOP since 1987

Main Member and 4 Affiliates (Tristate)Main Member and 4 Affiliates (Tristate)

Average over 400 NCI Treatment and Average over 400 NCI Treatment and Cancer Control Accruals AnnuallyCancer Control Accruals Annually

Over 5000 Participants in NCI TrialsOver 5000 Participants in NCI Trials

Members of 27 Cooperative Group Members of 27 Cooperative Group Committees (CALGB, NSABP, RTOG)Committees (CALGB, NSABP, RTOG)

Study Chair / Co-Chair: 3 Study Chair / Co-Chair: 3

Research ProgramResearch ProgramCCOP - 1987 CCOP - 1987

> 110 Clinical Trials > 110 Clinical Trials

Program expanded to includeProgram expanded to include– Translational ResearchTranslational Research– Physician Initiated ResearchPhysician Initiated Research– International Early Lung Cancer Action ProjectInternational Early Lung Cancer Action Project– Pharmaceutical ResearchPharmaceutical Research

Beebe Hospital

Union Hospital-Maryland

Cooper Hospital-New Jersey

Christiana CareHealth Services

HFGCC

A.I. duPont Hospital for Children

DE CCOP SitesDE CCOP Sites

DE

NJ

PA

MD

Research InfrastructureResearch Infrastructure

30 FTEs30 FTEs

SupportingSupporting– 7 Practices7 Practices– 26 Physicians (Medical Oncologists/Hematologists/ 26 Physicians (Medical Oncologists/Hematologists/

Radiation Oncologists)Radiation Oncologists)

Coverage provided to private practices, Cellular Coverage provided to private practices, Cellular Therapy Program; Prevention; Radiation Therapy Program; Prevention; Radiation Oncology; Surgical Oncology; Gynecology; Oncology; Surgical Oncology; Gynecology; Multidisciplinary CentersMultidisciplinary Centers

CCOP Accrual StrategiesCCOP Accrual Strategies

Infrastructure DevelopmentInfrastructure Development Clinical Investigator DevelopmentClinical Investigator Development CCOP CommunicationCCOP Communication Clinical Trial Portfolio DevelopmentClinical Trial Portfolio Development Community Marketing and EducationCommunity Marketing and Education CCOP PartnershipsCCOP Partnerships

CCOP Infrastructure CCOP Infrastructure DevelopmentDevelopment

CRA Expansion and LeadershipCRA Expansion and Leadership Umbrella CCOP IRBUmbrella CCOP IRB Dedicated Oncology Pharmacist ServicesDedicated Oncology Pharmacist Services Helen F. Graham Cancer Center Helen F. Graham Cancer Center

Multi-disciplinary Disease CentersMulti-disciplinary Disease Centers CRA Placement in Investigator Offices CRA Placement in Investigator Offices

and MDC’sand MDC’s

Clinical Investigator Clinical Investigator DevelopmentDevelopment

Accountability:Accountability: Publish Individual Investigator YTD AccrualPublish Individual Investigator YTD Accrual Cancer Center Participation CredentialingCancer Center Participation Credentialing

Recognition:Recognition: Individual Investigator Publicity and MarketingIndividual Investigator Publicity and Marketing Annual Investigator Accrual AwardsAnnual Investigator Accrual Awards Abstract and Manuscript AuthorshipAbstract and Manuscript Authorship Cooperative Group Committee Members Cooperative Group Committee Members

CCOP CommunicationCCOP Communication

Weekly CCHS Tumor Conference and Weekly CCHS Tumor Conference and Monthly DOCS (Clinical Trial Review)Monthly DOCS (Clinical Trial Review)

Monthly Clinical Research Meeting Monthly Clinical Research Meeting (Investigators and CRA’s)(Investigators and CRA’s)

Monthly Delaware Cancer Research NewsMonthly Delaware Cancer Research News Annual CCOP Summit ConferenceAnnual CCOP Summit Conference Affiliate Site Visits by CCOP Leadership Affiliate Site Visits by CCOP Leadership

TeamTeam

Clinical Trial Portfolio Clinical Trial Portfolio DevelopmentDevelopment

Full Disease Site AvailabilityFull Disease Site Availability Aggressive Phase II ActivationAggressive Phase II Activation Expanded Access (ECOG) & CTSUExpanded Access (ECOG) & CTSU Investigator “Friendly” Protocol ListInvestigator “Friendly” Protocol List

Paper and on Web Site (palm down load)Paper and on Web Site (palm down load) Monthly UpdateMonthly Update Pending Trial Opening StatusPending Trial Opening Status

High Accruing Investigator & Affiliate InputHigh Accruing Investigator & Affiliate Input

CCOP PartnershipsCCOP Partnerships

Hospital AdministrationHospital Administration IRBIRB DE Employers (MBNA, DuPont, DE Employers (MBNA, DuPont,

AstraZeneca)AstraZeneca) GovernmentGovernment

Governor Minner, Lt. Governor Carney, State Governor Minner, Lt. Governor Carney, State LegislatureLegislature

US Senator and Representative US Senator and Representative

Community MarketingCommunity Marketing

Christiana Care PublicationsChristiana Care Publications Community NewsCommunity News Monthly Employee and MD Staff NewsMonthly Employee and MD Staff News Annual Cancer ReportAnnual Cancer Report

Helen F. Graham Cancer Center High Helen F. Graham Cancer Center High Profile Activities and PublicationsProfile Activities and Publications

Local News Media (Newspapers, Local News Media (Newspapers, Magazines, Radio, Public and Cable Magazines, Radio, Public and Cable Television)Television)

Delaware Cancer Clinical Trials Delaware Cancer Clinical Trials BenefitBenefit

Raised Cancer Standard of CareRaised Cancer Standard of Care– Quality Physician RecruitmentQuality Physician Recruitment– Disciplined Cancer CareDisciplined Cancer Care

Reduction Cancer BurdenReduction Cancer Burden– State Cancer Mortality First to SixteenthState Cancer Mortality First to Sixteenth– Most Rapidly Declining State Annual Cancer Mortality Most Rapidly Declining State Annual Cancer Mortality

Rate, Twice the U.S. RateRate, Twice the U.S. Rate

Cancer & Leukemia Group BCancer & Leukemia Group B

Founded in 1956Founded in 1956

28 main members, 14 CCOPs, 225 affiliates28 main members, 14 CCOPs, 225 affiliates

Annual accrual: 4000 to 100 active studiesAnnual accrual: 4000 to 100 active studies

Headquarters: University of Chicago; Statistical Headquarters: University of Chicago; Statistical Center: Duke UniversityCenter: Duke University

Major institutions: Dana Farber, Memorial Sloan Major institutions: Dana Farber, Memorial Sloan Kettering, Georgetown, Duke, UNC, Wake Kettering, Georgetown, Duke, UNC, Wake Forest, University of Chicago, Ohio State, UCSFForest, University of Chicago, Ohio State, UCSF

Scientific OrganizationScientific Organization

Disease committeesDisease committees

Modality committeesModality committees

Specimen repositoriesSpecimen repositories

Image archivesImage archives

Reference laboratoriesReference laboratories

Statistical centerStatistical center

Clinical Research Clinical Research Associates Associates CommitteeCommittee

ChairChair

Kandie Dempsey, MS, RN, OCN, CCRPKandie Dempsey, MS, RN, OCN, CCRP

Vice-ChairVice-Chair

Barbara Barrett, MS, CCRPBarbara Barrett, MS, CCRP

Goals and ObjectivesGoals and ObjectivesDevelop and implement training programs to Develop and implement training programs to enhance skills and abilities of CRAs in all enhance skills and abilities of CRAs in all aspects of data collection and research.aspects of data collection and research.

Improve overall knowledge and professionalism Improve overall knowledge and professionalism to improve the integrity of study data.to improve the integrity of study data.

Contribute to scientific validity of CALGB Contribute to scientific validity of CALGB research.research.

Clinical Research Associates Clinical Research Associates Educational ProgramsEducational Programs

Clinical Research Associates Clinical Research Associates Educational ProgramsEducational Programs

CALGBCRA

ContinuingEducationWorkshop

CRAMeeting

CRAOrientation

AuditWorkshop

SurgicalProtocolsWorkshop

CollaborativeEducation

Major AccomplishmentsMajor Accomplishments Developed and implemented a formalized Developed and implemented a formalized

evaluation process for all CRA educational evaluation process for all CRA educational offerings to quantify success of the programs offerings to quantify success of the programs offered and to assist in the planning of future offered and to assist in the planning of future agendas.agendas.

Piloted Web-based EducationPiloted Web-based Education

Piloted CRA KiosksPiloted CRA Kiosks

Piloted Regional CRA Education Mentoring Project Piloted Regional CRA Education Mentoring Project (49907)(49907)

CALGaB Article ContributionsCALGaB Article Contributions

Specific Objectives and Future PlansSpecific Objectives and Future Plans

Collaborate with ACRIN to offer Collaborate with ACRIN to offer intergroup trials.intergroup trials.

Develop web-based educational Develop web-based educational programs for continuous membership programs for continuous membership access.access.

RESEARCH CURES RESEARCH CURES CANCERCANCER