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

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

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.

What influences accrual? Attitude - Enthusiasm

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

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

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

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

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.

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

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

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

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

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

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)

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)

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

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.

Knowledgeable Staff Coordinators Nurses Administrative Lab Radiation

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

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

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

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

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

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

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.

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.

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

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

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

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

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.)

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

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.

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

Thank you

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

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