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Advocating for Clinical Trial Accural

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Advocating for Clinical Trial Accural Suzanne LeGree, RN Cancer Prevention Nurse Coordinator Karen Van De Steeg Executive Director Clinical Trials Accrual at the June ... – PowerPoint PPT presentation

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Title: Advocating for Clinical Trial Accural


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. Nylen
Cancer Center and Siouxland Hematology-Oncology
Associates
3
  • 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

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
    centers 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, youll have
to remove your watch.
-Don
Mayne
9
Multiple Memberships
  • National Cancer Institute
  • Community Clinical Oncology Program
  • Industry (pharma companies)

10
Industry Associations
  • Amgen
  • Genentech
  • GSK
  • Wyeth
  • And others to fill the niche

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.

12
National Cancer Institute Associations
  • CCOPs involve thousands of medical professionals.
  • Mid 1980s Dr. Michalak joins ECOG as a Principal
    Investigator.

13
NCI CCOP
  • Siouxland Hematology-Oncology Associates
  • 6 medical oncologists plus staff
  • June E Nylen Cancer Center
  • 2 radiation oncologists plus staff

14
NCI CCOP
  • St. Lukes and Mercy
  • 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

19
Knowledgeable Staff
  • Coordinators
  • Nurses
  • Administrative
  • Lab
  • Radiation

20
(No Transcript)
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.

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
  • gt 15 of the potential participants are placed on
    clinical trials

35
Summary
  • Enthusiastic participation by physician-investigat
    ors 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
  • www.nylencancercenter.com
  • www.clinicaltrials.gov
  • www.cancer.gov
  • www.irb-irc.net/

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
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