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Research and Training

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... advancing cancer control through cancer research and health ... Basic concepts of cancer biology and research. Review of ACS Research and Training Program ... – PowerPoint PPT presentation

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Title: Research and Training


1
Research and Training

Jerome W. Yates, MD National Vice President of
Research
2
Clinical Trials and the Public
  • Participation in Clinical Trials
  • Influences on Participation
  • Public Participation in Research Review
  • (Stakeholders for the ACS)

3
PUBLIC INVOLVEMENT
Quality Assurance "Best Practices"
STAKEHOLDERS
IRB's ERB's
Treatment Research
Prevention Research
4
Role of the Players Scientist and
Stakeholder
5
What is a Stakeholder?
  • Stakeholder, Consumer or Patient Advocate
  • ACS Stakeholder is an individual with
  • A personal knowledge or experience with cancer
  • A strong interest in advancing cancer control
    through cancer research and health professional
    training.

6
What is the Role of a Stakeholder?
  • Insure the full discussion of cancer relevance at
    peer review committee meetings
  • Become a better informed resource for their home
    communities about the role of cancer research and
    training in the battle against cancer.

7
Candidate Training Process
  • Stakeholder Training Session
  • One and one-half days at NHO with Research
    Department Staff
  • Basic concepts of cancer biology and research
  • Review of ACS Research and Training Program
  • How the Peer Review Process works
  • How to review a grant application
  • Observation of Peer Review Committees
  • Attend 2 to 3 peer review committee meetings
  • Observe Stakeholders in action
  • Interact with Stakeholder Scientist members

8
Committee Assignment Process
  • Placement After Completion of Training
  • 2 year term on a Peer Review Committee
  • Self-selection by Stakeholder
  • Approval by Committee Program Director
  • 1 year term in the Ad Hoc Pool
  • Participate as a substitute at one Committee
    meeting
  • After one year, appointed to a 2 year term on a
    Peer Review Committee

9
COMMUN ITY ORGANIZATIONS SCHOOLS all
levels PUBLIC HEALTH ORGANIZATIONS SELF-EDUCATION
MEDICINE - COMMUNITY - ACADEMIC PUBLIC HEALTH
SCHOOLS ORGANIZATIONS - ACS
PUBLIC
INTERDISCIPLINARY TRAINING PROGRAMS
PUBLIC
MDs
MDs
INFORMED PERSON
PROVIDER TEAM
PREVENTION PROMOTE SELF-MANAGEMENT EARLY
DETECTION INTERDISCIPLINARY FACILITATION
STATE-OF-THE-ART ACCESS TO
TREATMENT PALLIATIVE CARE INTERDISCIPLINARY
CARE
10
PUBLIC INVOLVEMENT
RESEARCH DEVELOPMENT
Quality Assurance "Best Practices"
STAKEHOLDERS
IRB's ERB's
Treatment Research
Prevention Research
11
Public Participation
  • ADVANTAGES
  • COMMUNITY OPINIONS
  • INCREASED RESEARCH AWARENESS
  • RECRUIT RESEARCH ADVOCATES
  • PROVIDE OBJECTIVE RISK ASSESSMENT
  • DISADVANTAGES
  • PROGRAM COSTS
  • TRAINING EFFORTS
  • COMMITTEE DISCUSION TIME
  • PARTICIPANT COSTS
  • LEARNING TIME
  • REQUISITE EGO STRENGTH

12
Clinical Trial Participation
Physician
Trial
Patient
Information Dissemination
Awareness
Awareness
(Research Groups)
Trust Confidence in Their Physician
Patient Benefit
Eligibility
?
System Factors MD COMMITMENT OFFICE
EFFICIENCY FACILITATOR DATA MANAGEMENT COST
RECOVERY
Out of Pocket Inconvenience
ENTRY
13
Physician Attitudes RCTECOG 1485/1737 Responded
  • Improve Quality of Life Survival 83
  • Entered NO Patients next 12 mos. 62
  • 10 Physicians entered 80 patients in the next
    12 mos.
  • Physicians overestimated accrual X 6
  • Taylor et al. J Clin Oncol 1994. 12(12)2769-2770.

14
Participation in Clinical Trials
  • Patients
  • Younger
  • College Educated
  • Previous Participation
  • Nurses
  • Older
  • Research Nurses

15
NCI Survey706 Primary Care Physicians
  • Rarely Discuss Clinical Trials
  • Unaware of Pertinent Trials 37
  • Leave Discussion for Oncologist 41
  • Source Crosson, K. at al. J. Cancer Educ. 2001
    16 (4) 188-.

16
Attitudes RCT ParticipationLondon, England
NO
  • 29 (9)
  • 46 (15)
  • 101 (32)
  • YES
  • 287 (91)
  • 242 (77)
  • 141 (44)
  • 119 (38)
  • 260 (83)

Should Be Asked
Participate Without Randomization
With Randomization
When given added information
174
Source Fallowfield, LJ et al, Eur J Cancer
34(10)1554-1559.
17
CCOP Patient Log
  • Total 44,156 100
  • NCI Protocol
  • Available 17,773 40
  • Eligible 9,508 22
  • Entered 3,242 7
  • SourceHunter et al. Cancer Treatment Reports,
    1987 71(6) 559-565.

18
Age and Protocol Eligibility
409 516 1,256 2,300 4,432
4,971 3,021
SourceHunter et al. Cancer Treatment Reports,
1987 71(6) 559-565.
19
Eligible Patient Refusal
  • Experimentation 10
  • Expected Toxicity 4
  • Costs 2

20
Single Institution Experience
  • Total 276 100
  • Protocol Available 91 33
  • Eligible 76 28
  • Entered 39 14
  • Lara et al, JCO, 2001 19(6) 1728-2733

21
Phase I and II Why People Participate
Rx Trials
  • Verbal Communication - Essential
  • Hope for Cure
  • Trust their Oncologist
  • Colon Cancer
  • Reduce Chance of Cancer
  • Costs
  • Colonscopy

Prevention Trials
Barriers to Participation
22
Clinical Trial ParticipationPalliative Care
  • Population Available 1206 100
  • Eligible 558 46
  • Entered 362 30
  • Completed 248 21
  • Reasons Not to Participate
  • Deferral, Deterioration, Distance
  • Source Lung et al. Eur J Cancer 200 36(5)
    621-626.

23
Clinical Research Does Add to Cost NO x 3
61 124 1900
  • Wagner et al. J. National Cancer Institute
    1991(10) 847853.
  • Firemain et al. J. Natl Cancer Inst 2000
    92(2) 136-142.
  • Chivibos et al. Med Care 2001 39(4) 373-383.
    1900
  • Excludes 11 BMT Patients

24
Rural EnrollmentComparative Trial of PCP
Awareness
  • Interventions
  • Rapid tumor reporting system
  • Nurse facilitator Circuit Riding
  • Health Education
  • Newsletter to PCP
  • Community Wide Educator

Source Paskett ED et al, Cancer Pract, 2002
Jan-Feb 10(1) 28-35
25
Rural Enrollment Trial Facilitation
AREAS
Comparison
Intervention
  • PCP Awareness-
  • Before 41
  • After 43
  • Trial Enrollment Not Improved!!!

26
34
Source Paskett ED et al, Cancer Pract, 2002
Jan-Feb 10(1) 28-35
26
Complicated Protocols Excess Costs
Novel Treatment
Knowledge Education Recognition
Cost
VALUE
Value
VALUE
Reimbursement- NCI,
Industry, Payers Efficiencies-
Personnel, Space, Data
Poor Protocol
27
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28
Complicated Protocols Excess Costs
POSITIVE PROTOCOLS
Novel Treatment (EXCITING)
Knowledge Education Recognition
Cost
Value
Reimbursement- NCI,
Industry, Payers Efficiencies-
Personnel, Space, Data
Poor Protocol
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