Developing Relationships: Cooperative Group Networking

1. Developing Relationships:Cooperative Group Networking Kandie Dempsey, MS, RN, OCN, CCRP Delaware Christiana Care CCOP Christiana Care Health Services, Inc. Helen F. Graham Cancer Center ACRIN October 2, 2008

2. Goals • Scope of oncology research activities at the Delaware/ Christiana Care Research Program (CCOP). • Overview of research program • Mechanisms of success. • Benefits to the State & Community • Discuss collaboration with the CCOP & CALGB. • Overview of CALGB • CALGB Clinical Research Associates Committee. • .

3. DE Christiana Care CCOP • Funded CCOP since 1987 • Main Member and 4 Affiliates (Tristate) • Average over 400 NCI Treatment and Cancer Control Accruals Annually • Over 5000 Participants in NCI Trials • Members of 27 Cooperative Group Committees (CALGB, NSABP, RTOG) • Study Chair / Co-Chair: 3

4. Research Program • CCOP - 1987 • > 110 Clinical Trials • Program expanded to include • Translational Research • Physician Initiated Research • International Early Lung Cancer Action Project • Pharmaceutical Research

5. DE CCOP Sites A.I. duPont Hospital for Children Christiana CareHealth Services HFGCC PA Cooper Hospital-New Jersey NJ Union Hospital-Maryland MD Beebe Hospital DE

6. Research Infrastructure • 30 FTEs • Supporting • 7 Practices • 26 Physicians (Medical Oncologists/Hematologists/ Radiation Oncologists) • Coverage provided to private practices, Cellular Therapy Program; Prevention; Radiation Oncology; Surgical Oncology; Gynecology; Multidisciplinary Centers

7. CCOP Accrual Strategies • Infrastructure Development • Clinical Investigator Development • CCOP Communication • Clinical Trial Portfolio Development • Community Marketing and Education • CCOP Partnerships

8. CCOP Infrastructure Development • CRA Expansion and Leadership • Umbrella CCOP IRB • Dedicated Oncology Pharmacist Services • Helen F. Graham Cancer Center Multi-disciplinary Disease Centers • CRA Placement in Investigator Offices and MDC’s

9. Clinical Investigator Development • Accountability: • Publish Individual Investigator YTD Accrual • Cancer Center Participation Credentialing • Recognition: • Individual Investigator Publicity and Marketing • Annual Investigator Accrual Awards • Abstract and Manuscript Authorship • Cooperative Group Committee Members

10. CCOP Communication • Weekly CCHS Tumor Conference and Monthly DOCS (Clinical Trial Review) • Monthly Clinical Research Meeting (Investigators and CRA’s) • Monthly Delaware Cancer Research News • Annual CCOP Summit Conference • Affiliate Site Visits by CCOP Leadership Team

11. Clinical Trial Portfolio Development • Full Disease Site Availability • Aggressive Phase II Activation • Expanded Access (ECOG) & CTSU • Investigator “Friendly” Protocol List • Paper and on Web Site (palm down load) • Monthly Update • Pending Trial Opening Status • High Accruing Investigator & Affiliate Input

12. CCOP Partnerships • Hospital Administration • IRB • DE Employers (MBNA, DuPont, AstraZeneca) • Government • Governor Minner, Lt. Governor Carney, State Legislature • US Senator and Representative

13. Community Marketing • Christiana Care Publications • Community News • Monthly Employee and MD Staff News • Annual Cancer Report • Helen F. Graham Cancer Center High Profile Activities and Publications • Local News Media (Newspapers, Magazines, Radio, Public and Cable Television)

14. Delaware Cancer Clinical Trials Benefit • Raised Cancer Standard of Care • Quality Physician Recruitment • Disciplined Cancer Care • Reduction Cancer Burden • State Cancer Mortality First to Sixteenth • Most Rapidly Declining State Annual Cancer Mortality Rate, Twice the U.S. Rate

16. Cancer & Leukemia Group B • Founded in 1956 • 28 main members, 14 CCOPs, 225 affiliates • Annual accrual: 4000 to 100 active studies • Headquarters: University of Chicago; Statistical Center: Duke University • Major institutions: Dana Farber, Memorial Sloan Kettering, Georgetown, Duke, UNC, Wake Forest, University of Chicago, Ohio State, UCSF

17. Scientific Organization • Disease committees • Modality committees • Specimen repositories • Image archives • Reference laboratories • Statistical center

18. Clinical Research Associates Committee Chair Kandie Dempsey, MS, RN, OCN, CCRP Vice-Chair Barbara Barrett, MS, CCRP

19. Goals and Objectives • Develop and implement training programs to enhance skills and abilities of CRAs in all aspects of data collection and research. • Improve overall knowledge and professionalism to improve the integrity of study data. • Contribute to scientific validity of CALGB research.

20. CRAOrientation AuditWorkshop CRAMeeting CALGBCRA ContinuingEducationWorkshop SurgicalProtocolsWorkshop CollaborativeEducation Clinical Research Associates Educational Programs

21. Major Accomplishments • Developed and implemented a formalized evaluation process for all CRA educational offerings to quantify success of the programs offered and to assist in the planning of future agendas. • Piloted Web-based Education • Piloted CRA Kiosks • Piloted Regional CRA Education Mentoring Project (49907) • CALGaB Article Contributions

22. Specific Objectives and Future Plans • Collaborate with ACRIN to offer intergroup trials. • Develop web-based educational programs for continuous membership access.

23. RESEARCH CURES CANCER