Transcript Navigating the Clinical Trials Pathway

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. Nylen Cancer Center and
Siouxland Hematology-Oncology
Associates
“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
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)
Industry Associations
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Amgen
Genentech
GSK
Wyeth
And others to fill the niche
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.
National Cancer Institute
Associations
• CCOPs involve thousands of medical
professionals.
• Mid 1980s Dr. Michalak joins ECOG as a
Principal Investigator.
NCI CCOP
• Siouxland Hematology-Oncology Associates
– 6 medical oncologists plus staff
• June E Nylen Cancer Center
– 2 radiation oncologists plus staff
NCI CCOP
• St. Luke’s and Mercy
• 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
Knowledgeable Staff
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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.
Knowledgeable Lab
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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 breakthrough 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 physicianinvestigators 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?
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Chemo
Combination therapy
Other chemo and targeted therapy
More patients surviving longer