Research and Training

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Research and Training

Jerome W. Yates, MD National Vice President of
Research
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Clinical Trials and the Public

• Participation in Clinical Trials
• Influences on Participation
• Public Participation in Research Review
• (Stakeholders for the ACS)

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PUBLIC INVOLVEMENT
Quality Assurance "Best Practices"
STAKEHOLDERS
IRB's ERB's
Treatment Research
Prevention Research
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Role of the Players Scientist and
Stakeholder
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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.

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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.

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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

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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

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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
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PUBLIC INVOLVEMENT
RESEARCH DEVELOPMENT
Quality Assurance "Best Practices"
STAKEHOLDERS
IRB's ERB's
Treatment Research
Prevention Research
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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

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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
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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.

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Participation in Clinical Trials

• Patients
• Younger
• College Educated
• Previous Participation

• Nurses
• Older
• Research Nurses

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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-.

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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.
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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.

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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.
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Eligible Patient Refusal

• Experimentation 10
• Expected Toxicity 4
• Costs 2

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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

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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
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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.

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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

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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
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Rural Enrollment Trial Facilitation
AREAS
Comparison
Intervention

• PCP Awareness-
• Before 41
• After 43
• Trial Enrollment Not Improved!!!

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