Presentation on theme: "Advocating for Clinical Trial Accural"— Presentation transcript:
1Advocating for Clinical Trial Accural Suzanne LeGree, RNCancer Prevention Nurse CoordinatorKaren Van De SteegExecutive Director
2Clinical Trials Accrual at the June E Clinical Trials Accrual at the June E. Nylen Cancer Center and Siouxland Hematology-Oncology Associates
3National 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 - NCIHow many people in the audience have participated in studies.
5What influences accrual? Physicians and AdministrationMemberships/AssociationsKnowledgeable StaffParticipants
6Enthusiasm by Physicians The PhysiciansAn inherent belief that clinical trials are a necessary and beneficial component to a cancer center’s patient care system
7Enthusiasm about Clinical Trials The Physicians and AdministrationSupport the StaffEleven Research CoordinatorsOver 70 nurses, technicians, office staffTwo dosimetrists, One physicistNew Triology Equipment
8“This is your new work station… um, you’ll have to remove your watch.” -Don Mayne
9Multiple Memberships National Cancer Institute Community Clinical Oncology ProgramIndustry (pharma companies)This discussion will mainly be towards NCI that is how SHOA got started.
10Industry Associations AmgenGenentechGSKWyethAnd others to fill the niche…. Or put another way…
11National Cancer Institute Associations July 16, 1983 – NCI launched the Community Clinical Oncology Programto establish a cancer control effort that combines the expertise of community oncologists with NCI clinical research programs.SHOA staff nurses, schedulers, lab techniciansCancer Center staff, radiology technicians, radiations technicians, dosimetrist, physicists and nursesPathologists one is the pathology chairman for one of our groups NCCTGIRB members from both hospitals… more on IRBOthers MRI technicians, staff at satellites
12National Cancer Institute Associations CCOPs involve thousands of medical professionals.Mid 1980s Dr. Michalak joins ECOG as a Principal Investigator.SHOA staff nurses, schedulers, lab techniciansCancer Center staff, radiology technicians, radiations technicians, dosimetrist, physicists and nursesPathologists one is the pathology chairman for one of our groups NCCTGIRB members from both hospitals… more on IRBOthers MRI technicians, staff at satellites
13NCI CCOP Siouxland Hematology-Oncology Associates 6 medical oncologists plus staffJune E Nylen Cancer Center2 radiation oncologists plus staffSHOA staff nurses, schedulers, lab techniciansCancer Center staff, radiology technicians, radiations technicians, dosimetrist, physicists and nursesPathologists one is the pathology chairman for one of our groups NCCTGIRB members from both hospitals… more on IRBOthers MRI technicians, staff at satellites
14NCI CCOP St. Luke’s and Mercy Sixteen Satellite Clinics Pathologists IRB membersSixteen Satellite ClinicsAbben Cancer Center (Spencer, IA)
15CCOP MembershipsECOG – 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)
16CCOP 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)
17Lots of Memberships, Lots of Trials Types of Trials TreatmentPreventionCancer ControlSymptom Management/Quality of Life
18Types of Trials (continued) Ancillary Studies- Studies within StudiesQOLLab studiesPharmacokinetics, pharmacogenetics, EKGsIf 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.
21Knowledgeable Coordinators Research CRAs as CoordinatorsEducates and trains other staffCoordinates participant activityCertify as Research Professionals
22Knowledgeable Coordinators Research CRAs as RecruitersUpfront screening - charts for potential participantsActively Alerts Investigator to available trialsCommunity outreach projects
23Knowledgeable NursesKnowledge of the advantages and disadvantages of clincal trials participation for participants and staffConsent potential participantsAdministration of therapyEvaluation of adverse events
24Know the AdvantagesParticipants have access to promising new approaches that are often not available outside the clinical trial settingDoctors, nurses and staff gain upfront first –hand knowledge of cutting-edge therapies
25Know the AdvantagesRegular and careful medical attention from a team that includes doctors and other health professionalsFrequent monitoring may be necessary as part of the clinical trialResults from the study may help others in the future
26Know the Disadvantages New drugs or procedures under study may not be better than the standard treatmentNew treatments may have side effects or risks that doctors do not expectParticipants in randomized trials will not be able to choose the approach they receiveMore visits to the doctor may be required if part of a clinical trial
27Knowledgeable 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.
28Knowledgeable 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.
29Knowledgeable Lab Experienced in filling and packing kits IATA shipping trainedCLIA and COLA certificationTrusted track record in ancillary participation
30Knowledgeable Radiation Updating and training to the newest technologiesOffers wider clinical trial participationConventional vs IMRT gated treatment
31Willing ParticipantsOpportunity to receive the next break- through drugMeet a personal milestone(i.e., graduation, wedding, anniversary)Altruistic
32Accrual Summary January 1, 2008 through June 30, 2008 11.5% of all new patients were put on clinical trials
33Accrual 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.)
34Accrual 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
35SummaryEnthusiastic 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.