1. Advocating for Clinical Trial Accural
Suzanne LeGree, RN
Cancer Prevention Nurse Coordinator
Karen Van De Steeg
Executive Director

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

3. National Cancer Institute - NCI
“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
How many people in the audience have participated in studies.

4. What influences accrual?
Attitude - Enthusiasm

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

6. Enthusiasm by Physicians
The Physicians
An inherent belief that clinical trials are a necessary and beneficial component to a cancer center’s patient care system

7. Enthusiasm about Clinical Trials
The Physicians and Administration
Support the Staff
Eleven Research Coordinators
Over 70 nurses, technicians, office staff
Two dosimetrists, One physicist
New Triology Equipment

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

9. Multiple Memberships National Cancer Institute
Community Clinical Oncology Program
Industry (pharma companies)
This discussion will mainly be towards NCI that is how SHOA got started.

10. Industry Associations
Amgen
Genentech
GSK
Wyeth
And others to fill the niche
…. Or put another way…

11. 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.
SHOA staff nurses, schedulers, lab technicians
Cancer Center staff, radiology technicians, radiations technicians, dosimetrist, physicists and nurses
Pathologists one is the pathology chairman for one of our groups NCCTG
IRB members from both hospitals… more on IRB
Others MRI technicians, staff at satellites

12. National Cancer Institute Associations
CCOPs involve thousands of medical professionals.
Mid 1980s Dr. Michalak joins ECOG as a Principal Investigator.
SHOA staff nurses, schedulers, lab technicians
Cancer Center staff, radiology technicians, radiations technicians, dosimetrist, physicists and nurses
Pathologists one is the pathology chairman for one of our groups NCCTG
IRB members from both hospitals… more on IRB
Others MRI technicians, staff at satellites

13. NCI CCOP Siouxland Hematology-Oncology Associates
6 medical oncologists plus staff
June E Nylen Cancer Center
2 radiation oncologists plus staff
SHOA staff nurses, schedulers, lab technicians
Cancer Center staff, radiology technicians, radiations technicians, dosimetrist, physicists and nurses
Pathologists one is the pathology chairman for one of our groups NCCTG
IRB members from both hospitals… more on IRB
Others MRI technicians, staff at satellites

14. NCI CCOP St. Luke’s and Mercy Sixteen Satellite Clinics Pathologists
IRB members
Sixteen Satellite Clinics
Abben Cancer Center (Spencer, IA)

15. 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)

16. 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)

17. Lots of Memberships, Lots of Trials Types of Trials
Treatment
Prevention
Cancer Control
Symptom Management/Quality of Life

18. Types of Trials (continued)
Ancillary Studies- Studies within Studies
QOL
Lab studies
Pharmacokinetics, pharmacogenetics, EKGs
If you were on a trial it may have involved answering questionnaires or blood draws.
Genetic studies are done on blood or tissue to find out if researchers can predict who will respond to treatment.

19. Knowledgeable Staff
Coordinators
Nurses
Administrative
Lab
Radiation

21. Knowledgeable Coordinators
Research CRAs as Coordinators
Educates and trains other staff
Coordinates participant activity
Certify as Research Professionals

22. Knowledgeable Coordinators
Research CRAs as Recruiters
Upfront screening - charts for potential participants
Actively Alerts Investigator to available trials
Community outreach projects

23. Knowledgeable Nurses
Knowledge of the advantages and disadvantages of clincal trials participation for participants and staff
Consent potential participants
Administration of therapy
Evaluation of adverse events

24. 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

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

26. 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

27. 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.

28. Knowledgeable Administrative & 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.
Every study varies. These are important questions to ask before enrolling.

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

30. Knowledgeable Radiation
Updating and training to the newest technologies
Offers wider clinical trial participation
Conventional vs IMRT gated treatment

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

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

33. 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.)

34. 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

35. Summary
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.

36. Helpful Resources www.ecog.org ncctg.mayo.edu

37. Thank you

38. Targeted Therapy
Clinical trials are continuing to expand as clinical investigators test other agents
Focus is on molecular and cellular changes that are specific to cancer

39. Making Progress? Chemo Combination therapy
Other chemo and targeted therapy
More patients surviving longer