1. Advocating for Clinical Trial Accrual Karen Van De Steeg Executive Director

2. June E. Nylen Cancer Center Joint venture of Mercy and St. Luke’s in 1995 Free-standing outpatient facility Primary offices for medical and radiation oncologists

3. Mission To Provide the highest quality, compassionate care through prevention, treatment and research for the people of Siouxland

4. Screening Programs Coming Soon: CT Lung Cancer Screening

5. Patient Services Chemotherapy and medical oncology services Radiation therapy – Trilogy! PET/CT, CT, X-ray Dietitian, Patient navigator, Spiritual coordinator, Massage therapist, Accupuncturist, Wellness clinic, Art therapy, Support groups 16 satellite clinics

6. Research Mission driven commitment to: Providing the best possible care close to home Finding a cure for cancer

7. Clinical Trials Accrual at the June E. Nylen Cancer Center and Siouxland Hematology-Oncology Associates

8. “Clinical trials are research studies conducted with people who volunteer to take part. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of, and progress against, cancer. They also receive up-to-date care from experts.” National Cancer Institute - NCI

9. What influences accrual? Attitude = Enthusiasm

10. What influences accrual? Physicians and Administration Memberships/Associations Knowledgeable Staff Knowledgeable and Willing Participants

11. Enthusiasm by Physicians The Physicians must have: An inherent belief that clinical trials are a necessary and beneficial component to a cancer center’s patient care system Administration must have: The same commitment and financial resources

12. Physicians and Administration Support the Staff Protocol director Eleven research coordinators Over 70 nurses, technicians, office staff Two dosimetrists, two physicists Six Radiation therapists Support staff

13. “ This is your new work station… um, you’ll have to remove your watch.” -Don Mayne

14. Protocol Staff

15. Multiple Memberships National Cancer Institute Community Clinical Oncology Program Industry (pharma companies)

16. Industry Associations Amgen Genentech GSK Wyeth And others to fill the niche

17. National Cancer Institute Associations July 16, 1983 – NCI launched the Community Clinical Oncology Program –to establish a cancer control effort that combines the expertise of community oncologists with NCI clinical research programs.

18. National Cancer Institute Associations CCOPs involve thousands of medical professionals Mid-1980s Dr. Michalak joins ECOG as a Principal Investigator 2003 Dr Wender becomes Medical Director and PI

19. NCI CCOP June E Nylen Cancer Center, Sioux City, IA Sanford in Sioux Falls, SD and Fort Collins, CO St. Luke’s and Mercy Pathologists IRB members Sixteen Satellite Clinics Abben Cancer Center, Spencer, IA

20. NCI CCOP Siouxland Hematology-Oncology Associates –6 medical oncologists plus staff June E Nylen Cancer Center –2 radiation oncologists plus staff

21. CCOP Memberships ECOG – Eastern Cooperative Oncology Group (Boston, MA) NCCTG – North Central Cancer Treatment Group (Mayo Rochester, MN) NSABP – National Surgical Adjuvant Breast and Bowel Project (Pittsburgh, PA) CCCWFU – Comprehensive Cancer Center Wake Forest U (Winston-Salem, NC)

22. CCOP Memberships CTSU – Clinical Trials Support Unit (Rockville, MD) SWOG – Southwest Oncology Group (San Antonio, TX) CALGB – Cancer and Leukemia Group B (Chicago, IL) GOG – Gynecologic Oncology Group (Philadelphia, PA)

23. Lots of Memberships, Lots of Trials, Lots of Types of Trials

24. Treatment Prevention Cancer Control –Symptom Management/Quality of Life Ancillary Studies- Studies within Studies Quality of Life Lab studies: pharmacokinetics, pharmacogenetics, EKGs

25. Selecting Trials Sponsors send us protocols to review whether the sponsor is cooperative group or industry. PI reviews our ability to accrue based on potential study population, the study scientific integrity, and competing trials IRB process completed

26. Knowledgeable Physicians and Staff Receive summaries of all new protocols –Research staff –Nurses –Physicians Full copies in work room and on computer for all to view

27. Knowledgeable Staff Binders throughout the clinic containing the Clinical Trial Worksheets arranged by disease site –Contain brief eligibility criteria for each open study –Reference in which binder to locate the full version –About 200 binders in the workroom that need to be updated each time the protocol is amended –Need to make computer access to protocols more convenient

28. Know the Advantages Participants have access to promising new approaches that are often not available outside the clinical trial setting Doctors, nurses and staff gain upfront first- hand knowledge of cutting-edge therapies

29. Know the Advantages Regular and careful medical attention from a team that includes doctors and other health professionals Frequent monitoring as part of the clinical trial Results from the study may help others in the future

30. Know the Disadvantages New drugs or procedures under study may not be better than the standard treatment New treatments may have side effects or risks that doctors do not expect Participants in randomized trials will not be able to choose the approach they receive More visits to the doctor may be required if part of a clinical trial

31. Knowledgeable Coordinators Research CRAs as Coordinators Educate and train other staff Coordinate participant activity Certified as Research Professionals Industry studies are assigned based on the CRAs workload, and if they have experience with the study drug and sponsor Cooperative group studies are not assigned to individual CRAs

32. Knowledgeable Coordinators Research CRAs as Recruiters Upfront screening of EVERY patient chart for potential participants Actively alert Investigator to available trials Participate in community outreach projects

34. Knowledgeable Nurses Knowledge of the advantages and disadvantages of clinical trials participation for patients and staff Receive summaries of all protocols Review consent process for potential participants Administer therapy Evaluate adverse events

35. Knowledgeable Administrative & Billing Personnel “Medicare does not cover the patient care costs of clinical trials.” Response: June 7, 2000 – President Clinton issued an executive memorandum directing the Medicare program to reimburse providers for the cost of routine patient care in clinical trials.

36. Knowledgeable Billing Personnel “Health insurance will not cover the costs of a clinical trial.” Response: Many insurers and states cover the normal costs of treatment on cancer clinical trials. Check with your doctor or insurance plan to see if you are covered.

37. Knowledgeable Lab Experienced in filling and packing kits IATA shipping trained CLIA and COLA certification Trusted track record in ancillary participation

38. Knowledgeable Radiation Updating and training to the newest technologies Offers wider clinical trial participation Conventional vs IMRT or IGRT

39. Willing Participants Opportunity to receive the next break- through drug Meet a personal milestone (i.e., graduation, wedding, anniversary) Altruistic

40. Accrual Summary January 1, 2008 through June 30, 2008 11.5% of all new patients were put on clinical trials

41. Accrual Summary January 1, 2008 through June 30, 2008 13.8% of new patients when excluding patients that had disease for which we did not have a trial or otherwise exclusionary diseases (i.e. iron deficiency anemia, multiple sclerosis, Factor V patients, etc.)

42. Accrual Summary Add established patients with progressive disease Add participants that are not seen by our physicians for prevention and cancer control > 15% of the potential participants are placed on clinical trials

43. Belief in Research Enthusiastic participation by physician- investigators and administrators supporting a research project fosters the treatment environment necessary to create and promote clinical trials to the participant population.

45. Helpful Resources www.ecog.org ncctg.mayo.edu www.nylencancercenter.com www.clinicaltrials.gov www.cancer.gov www.irb-irc.net/

46. Thank you