1. Developing Relationships: Cooperative Group Networking 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. Beebe Hospital Union Hospital- Maryland Cooper Hospital- New Jersey Christiana Care Health Services HFGCC A.I. duPont Hospital for Children DE CCOP Sites DE NJ PA MD

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 Kandie Dempsey, MS, RN, OCN, CCRPVice-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. Clinical Research Associates Educational Programs CALGB CRA Continuing Education Workshop CRA Meeting CRA Orientation Audit Workshop Surgical Protocols Workshop Collaborative Education

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