Clinical Trials: Building Partnerships to
Improve Cancer Outcomes
Michigan Cancer Consortium
Update
April 21, 2004
The major advancements in cancer
prevention and clinical treatment are the
result of clinical research.
Cancer Clinical Trials
• Advance scientific knowledge
• Avoid useless treatment
• Offer options to those who have not
resp...
ASCO’s Definition of Clinical
Trials
• “Clinical investigation in oncology is
hypothesis-driven research that employs
meas...
Types of Clinical Trials
• Prevention = test new approaches (meds, vitamins, etc.)
that may ↓ risk of cancer
EX = Tamoxife...
Defining Clinical Trials Phases
Phase I = HOW DOES TREATMENT
AFFECT HUMANS?
TEST:
• safety
• toxicity
• feasibility
Small ...
Defining Clinical Trials Phases
Phase II = DOES THE DRUG DO WHAT
IT’S SUPPOSED TO DO?
• Test effect on a single type of ca...
Defining Clinical Trials Phases
Phase III = IS THE NEW DRUG A BETTER
ALTERNATIVE TO CURRENT PRACTICE?
• Last step in testi...
1997
• Increase participation in cancer clinical trials selected
as a priority of the MCC
U of M and MSHO Convene the Clinical
Trials Action Plan Committee
• Karmanos Cancer Institute
• Henry Ford Health System
•...
1998-1999 The Goal, Action Plan,
Timelines and Implementation Strategies
are Identified
“By the year 2005, double the
enro...
Implementation Plan
• Establish a mechanism
to measure clinical trials
participation
• Reduce physician and/or
provider bi...
Establishing a Mechanism to Measure
Michigan Patients and Providers
Participation in Clinical Trials
Clinical Trials Enrollment Pilot
– Collaboration among Michigan Public Health
Institute, MCC Clinical Trials Action Plan
C...
Cancer Clinical Trials Enrollment
Pilot Study
• Develop a baseline on cancer clinical trials
enrollments
• Develop methodo...
Need for a pilot study
• Baseline data are critical
• No single source of enrollment data
• Goal to increase enrollments i...
Who participated?
• Target population
– Universities
– Hospitals
– Cancer centers
– Community Clinical Oncology Programs
(...
Pilot Study Results
Figure 1. Gender of Persons Enrolled
Unknown
13%
Male
37%
Female
50%
Figure 2. Ethnicity of Persons En...
Moving Forward –
Funding the Next Phase
2004 Study Plans
• Target population
– Major cancer centers
– Community Clinical Oncology Programs
– Universities/individu...
2004 Study Plans
• Establish routine protocol to collect
enrollment data
• Measure change over 3 years in
– Number of pati...
Data Sources
• CDUS/CTES data
– Studies reporting data as part of Cancer
Therapy Evaluation Program
– No additional report...
Data Sources
• Industry
– Pharmaceutical & bio-tech companies
– Funded by For-profit unless investigator
initiated
• Insti...
Data Elements
• Number accrued by type of trial &
– Phase
• Treatment, prevention, cancer control, early
detection
– Patie...
2004 Time Line
• March – April
– Research investigators & managers register
online, by email, or mail
– CDUS data requeste...
2004 Time Line
• August
– Final follow-up on data submissions
– CDUS data received for 2001, 2002, 2003
• September
– Prep...
Changes in 2004 Study
• Clinical trials utilizing Cancer Therapy
Evaluation Program do not need to report
• Online data co...
Addressing Physician Bias
Physician Biases May Be the MOST
Important Influence in Patient
Enrollment
Patients will enroll when the physician
believe...
2000 MSHO MI Oncologists’
Clinical Trials Assessment
MSHO & Pharmacia partner
to determine Michigan
Medical Oncologists:
•...
MSHO Clinical Trials Assessment
Sample Questions (Strongly Agree to Strongly Disagree)
1. My practice is limited by the ho...
MSHO Oncologists’ Assessment
Results
• Rough measure of current participation levels
• Survey results confirmed many perce...
Physician Communication and Patient Decisionmaking
about Cancer Clinical Trials
Terrance L. Albrecht, Ph.D.
John C. Ruckde...
Reasons Patients Do or Do Not Enroll in Cancer
Clinical Trials
DO ENROLL: DO NOT ENROLL:
• Perceive their needs not
physic...
– Accrual more likely when MD:
• reviewed items in informed consent document, was
supportive, responsive and reflective
• ...
Primary Care Providers Attitudes About
Cancer Treatment Clinical Trials
Presenters/Authors:
Barbara Given, Charles W. Give...
Providers Need to:
• Provide patient information about trials and their
value to patients.
• Provide information to reduce...
Recommendations
• Policies and funding should be aimed toward
creating and implementing educational sessions on
clinical t...
Educational efforts targeted
• To physicians and NPs that practice in rural
settings.
• To physicians that practice in an ...
Categories of Approval
Network Cancer
Program (NCP)
NCI-designated
program
(NCIP)
Comprehensive
Cancer
Program
Teaching Ho...
American College of Surgeons: Commission on
Cancer Research Program Standards
• Information about the availability of canc...
Influencing Patient and Family
Attitudes
44
Characteristics of Patients Who Enter
Clinical Trials
Principal Investigators:
Aaron Scholnik, M.D.
Charles Given, Ph.D...
Conclusions
To improve accrual to cancer trials we should
1. Enhance the recognition, visibility, and credibility of
those...
Conclusions
4. Develop more trials – adjuvant & non-adjuvant that
serve males and disease sites other than breast
5. Offer...
Industry Generated Patient
Education
Insurance Industry Publications
Cancer Information Service
Clinical Trials Train the Trainer
Program
Using Media
• Publication inserts
• Editorial Boards
• Key local contacts for
press, radio and TV
• Advertising
Resolving Insurance Coverage
Issues for Those Enrolled in Clinical
Trials
The Issue
• The expansion of quality clinical
research needed to improve cancer
outcomes is impeded by patients’ and
provi...
The Dialogue Begins
March 5, 1999
Cancer Clinical Trials: Building
Partnerships for the Future
November 3, 1999
Senator Schwarz Convenes Meeting
at the Capitol
• A voluntary agreement for
routine patient care cost
cov...
“Cooperation not legislation
offers the greatest advantage to
Michigan’s cancer patients.”
The Honorable John J. H. Schwar...
Michigan Working Group to
Improve Cancer Outcomes
The Economic
Alliance for Michigan
Prostate Education
& Support Network
What Did Payers Say About Clinical
Trial Coverage Prior to 2000?
“Manage the benefit!”
• View all trials as “investigation...
Reality for Payers
• We already pay excessively for care in this
population
• Return on investment is poor
• The cost of c...
• Educated medical
directors
• Enlightened
administrators
• Educated patients
• Educated physicians
Solution=Barrier Remov...
Consensus Guidelines for Coverage of
Routine Patient Care Costs for Those
Enrolled in Clinical Trials
Michigan Working Group to Improve Cancer
Outcomes
Executive GroupPhilip Stella, MD
Mary Malloy
Tom Simmer, MD Sam Silver, ...
Clinical Trials
Costs/Responsibilities Model
• Administrative
Costs
(TrialSponsor)
• Investigative
Agents
(Pharmaceutical
...
Payer Issues and Restraints
• Contract language
• Extrapolation
• Fiduciary responsibility
• Moral responsibility
• Cost
Insurers’ Perspective
Traditional Experience
• Insurer paid for routine care because system
could not identify services pe...
Insurers’ Perspective
Traditional Experience
• Policies discourage participation in clinical trials.
• Off protocol delive...
Outline of the Consensus
Document
• Clinical Trial
Definitions and
Exclusions
• Rationale for
Supporting Clinical
Research...
Key Elements of the Consensus
Guidelines
• Voluntary agreement
• Rigorous patient
protection safeguards
are addressed
• Pe...
Health Plan Discretion
• Health Plans may grant “deemed status” to
investigators of institutions committed to
principles r...
Insurers’ Perspective
Implementing the Guidelines
• Insurers cover routine costs of medical
services delivered in clinical...
Insurers’ Perspective
Benefits
• Improved participation in clinical trials
• Better scientific validation of medical care
...
Insurers’ Perspective
Benefits
• Direct Costs
– Coverage for a better standard of care than is currently
being reimbursed
...
MAHP Clinical Trials Resource
Packet to
Primary Care Physicians
Collaboration with Minority
Agencies to Increase Diversity
Exploratory Meeting/ African
American Thought Leaders
• MDCH identifies and invites prominent African
American leaders to ...
Improving Cancer Outcomes of African
Americans In Michigan
Presented by: E. Yvonne Lewis
Michigan Cancer Consortium Board ...
Project Overview
• February 15, 2002
– Minority Enrollment Work Group of the Michigan Cancer
Consortium provided an overvi...
Identified Communities• Detroit (Wayne County)
• Flint (Genesee County)
• Lansing (Ingham County)
• Saginaw (Saginaw Count...
Problem Statement
African Americans are 33% more likely to die of
cancer than European Americans and are two
times more li...
Community Perspective
• Engage African American community
representatives from across socio-
economic strata to discuss an...
Community Project Design
• 2-3 representatives from each community were
identified to review the initial concept
• Additio...
Project Goals
• Increase awareness about cancer in the African
American Community
• Increase knowledge about cancer
• Incr...
Data Collection
• Modified Behavioral Risk Factor Survey
(BRFS)
• Specifically surveyed African Americans
in 5 communities...
Preliminary Outcomes
• Sample Statements
– “Surgery can cause cancer to spread to other parts of
the body”
– Range 62.3 – ...
Preliminary Outcomes
• African Americans are 2 times as likely to
have a fear of finding cancer
• 14% suspected that there...
Preliminary Outcomes
• Margin of 2:1
– African Americans found it more difficult to
communicate about cancer
– Believe tha...
Work Plans
• Each community was asked to develop a
work plan and strategies
• Each community would develop at least
two in...
Detroit Design Team• Focused Intervention
– Parish Nurse Community Cancer Education Outreach
• April 21, 2004
Training ses...
Flint Design Team• Focused Intervention
– Faith Based Leadership Series
• May 20 & 21, 2004
A training session to support ...
Lansing Design Team
• Focused Intervention
– Lift Every Voice: Colorectal Cancer Intervention
• March 18, 2004 Training
• ...
Saginaw Design Team
• Focused Intervention
– County Wide Essay Contest
• April 19-29, 2004
Engage school age children and ...
March
April May June July August September
Saginaw
March
School
Principal’s
Orientation
Lansing
March 18, 2004
Lift Every ...
Project Staff
• Project Director
• E. Yvonne Lewis, Executive Director
Faith Access to Community Economic Development
• Pr...
Acknowledgements
• Project Support
• A special thank you to the Steering Committee of the
Cancer Clinical Trails Committee...
Expanding Access and
Infrastructure Support to
Community Physicians
Growth of CCOPs in Michigan
Kalamazoo CCOP
Beaumont CCOP
Creating Awareness of Advances in
Clinical Trial Design & Research
Resources
• ABOUT THE CTSU The Cancer Trials Support Unit (CTSU) is a pilot project sponsored by the National Cancer
Institute (NCI)...
• Assurances and IRB Registration
• Compliance Oversight
• Education
• Policy Guidance
• Quality Program Improvement
• Wor...
Available Trainings for Staff
New to Clinical Research
• One day CE workshop
• Collaboration between
MSHO and Bristol
Myer...
Locating Information on Current
Trials
• Call your American Cancer Society toll free: 1-800-303-5691
• American Cancer Society/EmergingMed Clinical Trials Matchi...
• Updated: 12/18/2001
Related Pages:
Search for Clinical Trials
NCI's PDQ® database of cancer clinical trials.
User's Guid...
• Welcome to TrialCheckSM, Version 1.0
• The Coalition of National Cancer Cooperative Groups is proud
to offer TrialCheckS...
How Do We Proceed?
MCC Collaboration:
Measuring Clinical Trial Enrollment in
Michigan
• Champion importance of study with research
investigat...
MCC Collaboration:
Addressing Physician Bias
• Educate our medical colleagues about the benefits of referring
their patien...
MCC Collaboration:
Addressing Physician Bias
• Highlight participation in Clinical Trials as a Quality
Indicator for Provi...
MCC Collaboration:
Influencing Patient and Family
Attitudes
• Educate cancer patients and their families about the
benefit...
MCC Collaboration:
Influencing Patient and Family
Attitudes
• Engage Media/Public Press
– Identify and develop partnering ...
MCC Collaboration:
Resolving Insurance Coverage
Issues
• Promote awareness of the Guidelines to providers,
payers and purc...
MCC Collaboration:
Resolving Insurance Coverage
Issues
• Long term organization and funding of the Michigan
Working Group ...
MCC Collaboration:
Collaborating with Minority
Community Thought Leaders to
Increase Clinical Trials of
Underrepresented P...
MCC Collaboration:
Expanding Access and Infrastructure
Support to Community Physicians
• Contribute to the growth of CCOPs...
Clinical Trial Action Plan
Modifications
• Extend Goal Deadline to 2006
• Modify Workplan
– Dedicated Michigan Clinical Tr...
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  • Obtaining a baseline on enrollments in cancer clinical trials is one of the goals of the Michigan Cancer Consortium Initiative (MCCI). To do this accurately, a viable methodology needed to be developed to identify trial sites and to collect data on enrollments. The pilot study tested the feasibility of methods and materials to collect information on the enrollment of patients into cancer clinical trials in Michigan.
  • This pilot study was needed because:
    Baseline data is critical to assessing the attainment of other goals for enrollment in cancer clinical trials.
    There is no single source of information on persons enrolled in cancer clinical trials in Michigan.
    Clinical trials play a major role in the development of safe and effective treatments to reduce the societal burden of disease.
  • Institutions throughout Michigan that engaged in quality trials that advanced the science were invited to participate in the pilot study. The sampling plan did not target all sites that recruited patients into trials, but rather, focused on institutions that held responsibility for aggregating trial accrual numbers, typically those reporting these numbers to the funder.
  • Forty of 53 institutions eligible to participate in the study provided the requested information.
    A total of 3,711 patients were reported to be enrolled in cancer clinical trials for the year 2000 in Michigan.
    There were more females than males enrolled in cancer clinical trials
    Among persons whose ethnicity was reported, more than 8 in 10 enrollees (83.1%) in trials were white, 14.6% Black, 1% Asian, and other race/ethnicities each represented less than one percent of patients enrolled in cancer clinical trials in Michigan
    The majority of persons enrolled, whose ages were reported, were between age 50 and 69.
    About 7 in 10 persons enrolled in cancer clinical trials were participating in treatment trials.
    Only 2.6% of cancer patients potentially eligible for clinical trials enrollment were participating in a clinical trials in 2000.
    More than half of enrollees were participating in National Institutes of Health (NIH) trials.
  • There will be two major changes from the pilot study.
    First, the Michigan Public Health Institute will be requesting similar data for clinical trials that utilize the Cancer Therapy Evaluation Program (CTEP) through the National Cancer Institute Clinical Data Update System. Michigan clinical trials that report data to the CTEP will not need to submit data to the Michigan cancer clinical trials enrollment 2004 study. This should reduce the burden on clinical trials research staff.
    The second change is to use online data collection through a secure web-survey site. This will help participating institutions submit their data quickly and accurately without the use of paper forms.
  • b site at

    1. 1. Clinical Trials: Building Partnerships to Improve Cancer Outcomes Michigan Cancer Consortium Update April 21, 2004
    2. 2. The major advancements in cancer prevention and clinical treatment are the result of clinical research.
    3. 3. Cancer Clinical Trials • Advance scientific knowledge • Avoid useless treatment • Offer options to those who have not responded to standard treatment regimens • Reporting and analysis of adverse events improve care
    4. 4. ASCO’s Definition of Clinical Trials • “Clinical investigation in oncology is hypothesis-driven research that employs measurements in whole patients or normal human subjects, in conjunction with laboratory measurements as appropriate, on the subjects of clinical biology, natural history, prevention, screening, diagnosis, therapy or epidemiology of neoplastic disease.”
    5. 5. Types of Clinical Trials • Prevention = test new approaches (meds, vitamins, etc.) that may ↓ risk of cancer EX = Tamoxifen study, STAR Trial • Screening = test best ways to detect cancer in early stages • Treatment = test new treatments (drugs, surgery, radiation, combinations, or new methods such as gene therapy examples = ---BMT and high dose chemo ---Sentinel node biopsy in breast cancer ---PET replace CT and MRI in staging esophageal and non-small cell lung ca • QOL = also called supportive care trials; explore ways to
    6. 6. Defining Clinical Trials Phases Phase I = HOW DOES TREATMENT AFFECT HUMANS? TEST: • safety • toxicity • feasibility Small number of patients (15- 30) with advanced cancer who have exhausted other treatments; less likely they will personally benefit
    7. 7. Defining Clinical Trials Phases Phase II = DOES THE DRUG DO WHAT IT’S SUPPOSED TO DO? • Test effect on a single type of cancer Slightly larger # patients (30 - 50) than Phase I trial Patients for whom conventional treatment has failed; some possibility that patient will benefit from the treatment. Only ~ 33% of drugs tested in Phase II are found safe, effective enough to go to Phase III
    8. 8. Defining Clinical Trials Phases Phase III = IS THE NEW DRUG A BETTER ALTERNATIVE TO CURRENT PRACTICE? • Last step in testing • Randomized controlled trials that determine how a new treatment compares with the current, standard treatment (Participants are randomized into 2 groups:standard of care vs. new treatment Require large #’s patients (100’s or 1000’s)-- conducted thru many settings nationwide
    9. 9. 1997 • Increase participation in cancer clinical trials selected as a priority of the MCC
    10. 10. U of M and MSHO Convene the Clinical Trials Action Plan Committee • Karmanos Cancer Institute • Henry Ford Health System • Michigan State University Cancer Center • Ann Arbor CCOP • Grand Rapids CCOP • Kalamazoo CCOP • Blue Cross Blue Shield • Coalition of National Cancer Cooperative Groups • Michigan Osteopathic Association • Oncology Nursing Society • American Cancer Society • Cancer Information Service • Amgen
    11. 11. 1998-1999 The Goal, Action Plan, Timelines and Implementation Strategies are Identified “By the year 2005, double the enrollment and increase diversity in cancer clinical trials”
    12. 12. Implementation Plan • Establish a mechanism to measure clinical trials participation • Reduce physician and/or provider bias • Resolve insurance coverage issues • Collaborate with minority agencies to increase diversity • Influence patient attitudes • Advocate for improvement in clinical trial design and eligibility • Expand access and infrastructure support to community physicians • Support efforts by accrediting bodies to include clinical trial participation criteria
    13. 13. Establishing a Mechanism to Measure Michigan Patients and Providers Participation in Clinical Trials
    14. 14. Clinical Trials Enrollment Pilot – Collaboration among Michigan Public Health Institute, MCC Clinical Trials Action Plan Committee, MSHO, MDCH and Michigan Working Group to Improve Cancer Outcomes members. Current Project Leader: Sandra Herman, Ph.D
    15. 15. Cancer Clinical Trials Enrollment Pilot Study • Develop a baseline on cancer clinical trials enrollments • Develop methodology to – Identify trial sites – Collect enrollment data • Test feasibility of methods & materials
    16. 16. Need for a pilot study • Baseline data are critical • No single source of enrollment data • Goal to increase enrollments in clinical trials
    17. 17. Who participated? • Target population – Universities – Hospitals – Cancer centers – Community Clinical Oncology Programs (CCOPs) • 53 eligible institutions identified
    18. 18. Pilot Study Results Figure 1. Gender of Persons Enrolled Unknown 13% Male 37% Female 50% Figure 2. Ethnicity of Persons Enrolled 83.1% 14.6% 2.4% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0% White Black All other Figure 3. Ages of Persons Enrolled 2.8% 24.0% 51.4% 16.6% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0% 15-29 30-49 50-69 70 + Figure 4. Erollment by Sponsor Type NIH 55%Intramural 26% Industry 19%
    19. 19. Moving Forward – Funding the Next Phase
    20. 20. 2004 Study Plans • Target population – Major cancer centers – Community Clinical Oncology Programs – Universities/individual physicians with industry sponsored trials – Universities/individual physicians with institutional sponsored trials
    21. 21. 2004 Study Plans • Establish routine protocol to collect enrollment data • Measure change over 3 years in – Number of patients enrolled – Diversity of patients enrolled • Monitoring tool for MCC objective on clinical trials
    22. 22. Data Sources • CDUS/CTES data – Studies reporting data as part of Cancer Therapy Evaluation Program – No additional reporting on these trials
    23. 23. Data Sources • Industry – Pharmaceutical & bio-tech companies – Funded by For-profit unless investigator initiated • Institutional – Investigator initiated non-industry trials – Investigator initiated industry trials – R01 trials
    24. 24. Data Elements • Number accrued by type of trial & – Phase • Treatment, prevention, cancer control, early detection – Patient gender – Patient race/ethnicity – Age group • 18-30, 31-49, 50-69, 70 or older
    25. 25. 2004 Time Line • March – April – Research investigators & managers register online, by email, or mail – CDUS data requested • May – Data collection forms mailed • May – July – Data submitted online, by email, or mail
    26. 26. 2004 Time Line • August – Final follow-up on data submissions – CDUS data received for 2001, 2002, 2003 • September – Preparation of report
    27. 27. Changes in 2004 Study • Clinical trials utilizing Cancer Therapy Evaluation Program do not need to report • Online data collection available
    28. 28. Addressing Physician Bias
    29. 29. Physician Biases May Be the MOST Important Influence in Patient Enrollment Patients will enroll when the physician believes that the trial is sound medically and scientifically and that as an “expert surrogate” he would be willing to personally participate in the trial
    30. 30. 2000 MSHO MI Oncologists’ Clinical Trials Assessment MSHO & Pharmacia partner to determine Michigan Medical Oncologists: • Current level of clinical trial participation • Actual and perceived barriers to clinical trial participation • Attitudes about clinical research
    31. 31. MSHO Clinical Trials Assessment Sample Questions (Strongly Agree to Strongly Disagree) 1. My practice is limited by the hospital or HMO formulary. 2. Hospital policy dictates some of my treatment options. 3. Protocols do not include all patients and are therefore too restrictive. 4. My income is adversely affected by placing patients on clinical trials. 5. Protocols do not always include what I consider standard therapy. 6. I am concerned about being audited by insurers who exclude payments for clinical trials. 7. Other responsibilities prevent me from learning what I need to know to place patients on clinical trials. 8. Protocols require a large increase in time spent on each patient.
    32. 32. MSHO Oncologists’ Assessment Results • Rough measure of current participation levels • Survey results confirmed many perceived research concerns and barriers • Identified possible behavioral change opportunities for physicians who do not enroll patients on studies • Revealed a large information gap – 25% of responding oncologists had very limited clinical trial awareness
    33. 33. Physician Communication and Patient Decisionmaking about Cancer Clinical Trials Terrance L. Albrecht, Ph.D. John C. Ruckdeschel, M.D. Louis A. Penner, Ph.D. Barbara Ann Karmanos Cancer Institute Wayne State University School of Medicine Presented to Grand Rounds, MD Anderson Cancer Center, Houston, TX, November 17, 2003. Not for citation without permission.
    34. 34. Reasons Patients Do or Do Not Enroll in Cancer Clinical Trials DO ENROLL: DO NOT ENROLL: • Perceive their needs not physician’s priority • Disrupt quality of life, functional abilities • Anxiety about randomization • Worry might not receive best treatment • Concern about logistical difficulties • Perceive insurance problems • Concern about excessive toxicity • Poor understanding of study • Family against study participation • Worry about excessive burden on family/friends  Trust in their physician  Physician recommended study  Physician responsive to questions and issues  Encouragement by family  Manageable side effects  Altruism Desire to live Albrecht,T. Ruckdeschel et al 2003
    35. 35. – Accrual more likely when MD: • reviewed items in informed consent document, was supportive, responsive and reflective • discussed benefits, side effects, patient concerns and resources to manage concerns Physicians using both legal/info and social influence strategies enrolled more patients Albrecht, T, Ruckdeschel et al 2003
    36. 36. Primary Care Providers Attitudes About Cancer Treatment Clinical Trials Presenters/Authors: Barbara Given, Charles W. Given, Aaron Scholnik, Pam Patterson and Paula Sherwood Michigan State University East Lansing, MI 02-606
    37. 37. Providers Need to: • Provide patient information about trials and their value to patients. • Provide information to reduce uncertainty. • Watch interaction – demeanor of physician critical to patient decision. • Providers need to decrease logistic barriers to trial participation. • Encourage and communicate with patients to facilitate understanding. 02-624
    38. 38. Recommendations • Policies and funding should be aimed toward creating and implementing educational sessions on clinical trials for both physicians and NPs. • Education should be included in NP programs as well as medical school and residency programs to establish basic patterns of referral. • This education should be continued with a variety of techniques and mechanisms. • Efforts need to be directed toward making information appropriate to primary care practice. 02-622
    39. 39. Educational efforts targeted • To physicians and NPs that practice in rural settings. • To physicians that practice in an urban setting and NPs that practice in a suburban setting. • To younger physicians. • To NPs in general. • Focus on: – General knowledge as well as how to access trials. – Potential barriers to patient access. – Responsibilities when a patient enters a trial. • Information on the scientific design and oversight and primary care of patients on trials. 02-
    40. 40. Categories of Approval Network Cancer Program (NCP) NCI-designated program (NCIP) Comprehensive Cancer Program Teaching Hospital Cancer Program (THCP) Community Hospital Comprehensive Cancer Program (COMP) Community Hospital Cancer Program (CHCP) Hospital Associate Cancer Program (HACP) Affiliate Hospital Cancer Program (ACP) Integrated Cancer Program (ICP) Freestanding Cancer Center Program (FCCP
    41. 41. American College of Surgeons: Commission on Cancer Research Program Standards • Information about the availability of cancer- related clinical trials is provided to patients through a formal mechanism • As appropriate to the category, the required percentage of cases is accrued to cancer-related clinical trials on an annual basis • The commendation percentage of cases for the category is accrued to cancer-related clinical trials each year
    42. 42. Influencing Patient and Family Attitudes
    43. 43. 44 Characteristics of Patients Who Enter Clinical Trials Principal Investigators: Aaron Scholnik, M.D. Charles Given, Ph.D. Barbara Given, Ph.D., R.N., F.A.A.N. Project Manager: Pam Patterson, M.S., R.N. Data Manager/Analyst (MSU-DCC): Jian-Ping He, M.D., M.S.
    44. 44. Conclusions To improve accrual to cancer trials we should 1. Enhance the recognition, visibility, and credibility of those physicians & institutions that participate in cancer clinical trials 2. Educate the public about the benefits of participating in clinical trials 3. Educate our medical colleagues about the benefits of referring their patients to physicians & institutions that participate in cancer clinical trials
    45. 45. Conclusions 4. Develop more trials – adjuvant & non-adjuvant that serve males and disease sites other than breast 5. Offer all trials to appropriate, good performance status elderly patients 6. Work with our ethicists, IRB’s, and behavioral experts to structure our presentation of clinical trials, including “consent forms” to take advantage of the importance of “doctor influence” and “altruism” and to better present the scope of “positive” and “negative” effects of investigational treatments
    46. 46. Industry Generated Patient Education
    47. 47. Insurance Industry Publications
    48. 48. Cancer Information Service Clinical Trials Train the Trainer Program
    49. 49. Using Media • Publication inserts • Editorial Boards • Key local contacts for press, radio and TV • Advertising
    50. 50. Resolving Insurance Coverage Issues for Those Enrolled in Clinical Trials
    51. 51. The Issue • The expansion of quality clinical research needed to improve cancer outcomes is impeded by patients’ and providers’ reluctance to participate in trials without assurance of health plan coverage.
    52. 52. The Dialogue Begins March 5, 1999 Cancer Clinical Trials: Building Partnerships for the Future
    53. 53. November 3, 1999 Senator Schwarz Convenes Meeting at the Capitol • A voluntary agreement for routine patient care cost coverage among those most involved in the process was encouraged by the MDCH.
    54. 54. “Cooperation not legislation offers the greatest advantage to Michigan’s cancer patients.” The Honorable John J. H. Schwarz, M.D.
    55. 55. Michigan Working Group to Improve Cancer Outcomes The Economic Alliance for Michigan Prostate Education & Support Network
    56. 56. What Did Payers Say About Clinical Trial Coverage Prior to 2000? “Manage the benefit!” • View all trials as “investigational” • Build the infrastructure for denial Carver – Michigan Working Group Meeting February 23, 2000
    57. 57. Reality for Payers • We already pay excessively for care in this population • Return on investment is poor • The cost of clinical trial participation is at worst comparable to usual care Carver – Michigan Working Group Meeting February 23, 2000
    58. 58. • Educated medical directors • Enlightened administrators • Educated patients • Educated physicians Solution=Barrier Removal Carver – Michigan Working Group Meeting February 23, 2000
    59. 59. Consensus Guidelines for Coverage of Routine Patient Care Costs for Those Enrolled in Clinical Trials
    60. 60. Michigan Working Group to Improve Cancer Outcomes Executive GroupPhilip Stella, MD Mary Malloy Tom Simmer, MD Sam Silver, MD Marshall Katz, MD Gene Farnum Carolyn Schmit, RN Bob Chapman, MD Mike Rosenberg, MD Carol Callaghan Sue Haviland Aaron Scholnick MD Noah Smith Chris Goeschels RN Beverly Blaney, MD Ellen Sprental- Nakervis Charles Schiffer, MD Chuck Gayney Laura Champagne Joe Carver, MD Bruce Carl, MD MBA Jim Ball Sheldon Schwartz Ed Ervin Oliver Kim Prostate Education & Support Network The Economic Alliance for Michigan
    61. 61. Clinical Trials Costs/Responsibilities Model • Administrative Costs (TrialSponsor) • Investigative Agents (Pharmaceutical Company) • Routine Patient Care Costs (Insurer/Accounts) • Exceptional Tests (Trial Sponsor)
    62. 62. Payer Issues and Restraints • Contract language • Extrapolation • Fiduciary responsibility • Moral responsibility • Cost
    63. 63. Insurers’ Perspective Traditional Experience • Insurer paid for routine care because system could not identify services performed in a clinical trial from other services. • Payments denied based on claims edits are often successfully appealed. • Denials for investigational services lead to lawsuits Simmer – 2001 MCC Annual Meeting
    64. 64. Insurers’ Perspective Traditional Experience • Policies discourage participation in clinical trials. • Off protocol delivery of unproven services discourages participation in clinical trials. • Unproven services become standard practice without adequate scientific validation. • Medical care less evidence based than optimal Simmer – 2001 MCC Annual Meeting
    65. 65. Outline of the Consensus Document • Clinical Trial Definitions and Exclusions • Rationale for Supporting Clinical Research Efforts • Criteria for “Approved” Clinical Trials • Costs Associated with Cancer Clinical Trials • Policy Issues and Concerns • Essential Elements of Consensus Guidelines
    66. 66. Key Elements of the Consensus Guidelines • Voluntary agreement • Rigorous patient protection safeguards are addressed • Peer review scrutiny of trial design for therapeutic benefit & scientific validity is required • Coverage applies to Phase II and Phase III • Off Protocol use of any protocol is not covered under this agreement • Coverage includes costs associated with routine patient care, delivery of the investigational agent or service and adverse effects
    67. 67. Health Plan Discretion • Health Plans may grant “deemed status” to investigators of institutions committed to principles represented in this document. • Health Plans may revoke “deemed status” for violations or abuse of principles represented in this document. • Clinical trials related to cancer prevention and/or performed at institutions not listed in document criteria may be covered outside the scope of this agreement by individual health plans according to their policies and procedures.
    68. 68. Insurers’ Perspective Implementing the Guidelines • Insurers cover routine costs of medical services delivered in clinical trials. • Insurers override payment edits for off-label and unproven indications when members are enrolled in clinical trials. • Off protocol delivery of investigational treatment remains beyond scope of coverage Simmer – 2001 MCC Annual Meeting
    69. 69. Insurers’ Perspective Benefits • Improved participation in clinical trials • Better scientific validation of medical care • Improved cooperation between investigators and insurers • More effective restriction of investigational services to investigational settings Simmer – 2001 MCC Annual Meeting
    70. 70. Insurers’ Perspective Benefits • Direct Costs – Coverage for a better standard of care than is currently being reimbursed • Indirect Costs – Better outcomes for cancer patients – Fewer costly reviews – Reduced litigation – Improved public relations for insurers and their accounts – Advancement of the science Simmer – 2001 MCC Annual Meeting
    71. 71. MAHP Clinical Trials Resource Packet to Primary Care Physicians
    72. 72. Collaboration with Minority Agencies to Increase Diversity
    73. 73. Exploratory Meeting/ African American Thought Leaders • MDCH identifies and invites prominent African American leaders to meet with the directors of Michigan’s research programs. • Feasibility of a “Blue Ribbon” advisory panel will be proposed for collaboration on strategies to resolve insufficient minority participation in clinical research. • Group initially convened by MDCH, December, 2000
    74. 74. Improving Cancer Outcomes of African Americans In Michigan Presented by: E. Yvonne Lewis Michigan Cancer Consortium Board Meeting April 21, 2003 Lyon Meadows Conference Center New Hudson, MI
    75. 75. Project Overview • February 15, 2002 – Minority Enrollment Work Group of the Michigan Cancer Consortium provided an overview of the concept for a project to “Increase African American Participation in Cancer Clinical Trials” – Concept was intended to have statewide impact, involving five large communities – A total of 1,147,375 African Americans resided in these counties, constituting 81.3% of Michigan’s black population
    76. 76. Identified Communities• Detroit (Wayne County) • Flint (Genesee County) • Lansing (Ingham County) • Saginaw (Saginaw County) • Pontiac (Oakland County)
    77. 77. Problem Statement African Americans are 33% more likely to die of cancer than European Americans and are two times more likely to die of cancer than Asians, Native Americans, and Hispanics. The purpose of this initiative is to reduce the unequal burden of cancer and improve the quality of life of African Americans in Michigan.
    78. 78. Community Perspective • Engage African American community representatives from across socio- economic strata to discuss and plan ideas to best engage members of their communities to address the issues of cancer • Form teams in each community to ensure the goals of the project are met
    79. 79. Community Project Design • 2-3 representatives from each community were identified to review the initial concept • Additional representatives were engaged to develop the Design Team • Each team would develop strategies to engage the larger community • All teams would meet to develop a statewide strategy
    80. 80. Project Goals • Increase awareness about cancer in the African American Community • Increase knowledge about cancer • Increase communication about cancer • Decrease myths about cancer • Increase screening and utilization of cancer
    81. 81. Data Collection • Modified Behavioral Risk Factor Survey (BRFS) • Specifically surveyed African Americans in 5 communities • 2194 respondents – overall response rate 52.7%
    82. 82. Preliminary Outcomes • Sample Statements – “Surgery can cause cancer to spread to other parts of the body” – Range 62.3 – 79.9 – Some cancers can be prevented – Range 84.4 – 93.8 – A diagnosis of cancer is a death sentence – Range 4.8 – 33.5 – A Higher Power decides if a person survives or dies from any cancer – Range 67.9 -82.9
    83. 83. Preliminary Outcomes • African Americans are 2 times as likely to have a fear of finding cancer • 14% suspected that there is no cure • African Americans are more fatalistic
    84. 84. Preliminary Outcomes • Margin of 2:1 – African Americans found it more difficult to communicate about cancer – Believe that early diagnosis means more time to worry – More likely to have difficulty arranging transportation and childcare
    85. 85. Work Plans • Each community was asked to develop a work plan and strategies • Each community would develop at least two interventions – 1) Focused – addressing a specific segment of the African American community – 2) Community wide – addressing the broader community to promote awareness and involvement
    86. 86. Detroit Design Team• Focused Intervention – Parish Nurse Community Cancer Education Outreach • April 21, 2004 Training session to support Parish Nurses in collectively addressing cancer in the African American community. • Community Wide Intervention – City Council Town Hall Meeting • Mid May 2004 Panel Discussion on cancer in the African American community – Praise Fest: Cancer Education & Screening • June 13 & 14, 2004 Host an interactive health segment at this event that would include celebration of life, honoring survivorship; information workshops, BCCCP recruitment, screening, and risk assessments.
    87. 87. Flint Design Team• Focused Intervention – Faith Based Leadership Series • May 20 & 21, 2004 A training session to support faith community leaders in collectively addressing cancer in the African American community. • Community Wide Intervention – Family Reunion BBQ • August 21, 2004 Citywide event to mobilize the African American community and engage them around the issue of cancer.
    88. 88. Lansing Design Team • Focused Intervention – Lift Every Voice: Colorectal Cancer Intervention • March 18, 2004 Training • April –May, 2004 Implementation Modifications of the Tell-A-Friend Model to address colorectal cancer in the African American community. • Community Wide Intervention – Straight Talk About Cancer • September 2004 • In partnership with the American Cancer Society host a training session to support African American community leaders in collectively addressing cancer in the African American community and spreading the message to their constituencies
    89. 89. Saginaw Design Team • Focused Intervention – County Wide Essay Contest • April 19-29, 2004 Engage school age children and their families through an essay contest. Six schools identified - Houghton, Jones, Heavenrich, & Claytor Elementary Schools and Central, Webber, & Ricker Middles Schools • Community Wide Intervention – Health Expo • June 5-6, 2004 Engage the larger community by partnering with Greater Coleman Temple C.O.G.I.C. in African American Health Expo. ICOAA will host workshops and panel discussions that address cancer in the African American community.
    90. 90. March April May June July August September Saginaw March School Principal’s Orientation Lansing March 18, 2004 Lift Every Voice Training Flint March 31, 2004 Family Reunion Implementation Team Orientation Detroit Mid-May City Council Town Hall Meeting Flint May 20& 21, 2004 Faith Leaders Training Saginaw June 5, 2004 African American Health Expo Detroit June 12 & 13, 2004 Praise Fest Flint August 21, 2004 Family Reunion Lansing Early- Sept. Straight Talk About Cancer Saginaw Essay Contest Lansing Lift Every Voice Implementation Detroit April 21, 2004 Parish Nurse Training Timeline
    91. 91. Project Staff • Project Director • E. Yvonne Lewis, Executive Director Faith Access to Community Economic Development • Project Specialist • Latecia Matthews • Community Design Team • Community Liaisons
    92. 92. Acknowledgements • Project Support • A special thank you to the Steering Committee of the Cancer Clinical Trails Committee and the Minority Enrollment Work group of the Michigan Cancer Consortium as well as: – MDCH Cancer Section for funding the project • Carol Callaghan – Director of Chronic Disease – MDCH • Dr. Phil Stella • Patricia Brookover – Michigan Department of Community Health • Sue Brown - Michigan Department of Community Health
    93. 93. Expanding Access and Infrastructure Support to Community Physicians
    94. 94. Growth of CCOPs in Michigan Kalamazoo CCOP Beaumont CCOP
    95. 95. Creating Awareness of Advances in Clinical Trial Design & Research Resources
    96. 96. • ABOUT THE CTSU The Cancer Trials Support Unit (CTSU) is a pilot project sponsored by the National Cancer Institute (NCI) for the support of a national network of physicians to participate in NCI-sponsored Phase III cancer treatment trials. The majority of these trials are sponsored by the adult Cooperative Clinical Trials Groups listed here. ACOSOG - (American College of Surgeons Oncology Group) CALGB - (Cancer and Leukemia Group B) ECOG - (Eastern Cooperative Oncology Group) GOG - (Gynecologic Oncology Group) NCIC CTG - (National Cancer Institute of Canada Clinical Trials Group) NCCTG - (North Central Cancer Treatment Group) NSABP - (National Surgical Adjuvant Breast and Bowel Project) RTOG - (Radiation Therapy Oncology Group) SWOG - (Southwest Oncology Group) CTSU Objectives: • Increase physician and patient access to NCI-sponsored clinical trials • Streamline and standardize trial data collection and reporting • Reduce regulatory/administrative burden on investigators participating in NCI-sponsored Cooperative Group clinical trials (phases 1-3) C I C C T G - ( N a t i o n a l C a n c e r I n s t i t u t e o f C a n a d a C l i n i c a l T r i a l s G r o u p ) N C C T G - C I C C T G - ( N a t i o n a l C a n c e r I n s t i t u t e o f C a n a d a C l i n i c a l T r i a l s G r o u p ) N C C T G -
    97. 97. • Assurances and IRB Registration • Compliance Oversight • Education • Policy Guidance • Quality Program Improvement • Workshops
    98. 98. Available Trainings for Staff New to Clinical Research • One day CE workshop • Collaboration between MSHO and Bristol Myers Squibb Oncology • No cost to physician offices
    99. 99. Locating Information on Current Trials
    100. 100. • Call your American Cancer Society toll free: 1-800-303-5691 • American Cancer Society/EmergingMed Clinical Trials Matching Service • This free Clinical Trial Matching and Referral Service is made available to American Cancer Society visitors through a collaboration with EmergingMed. Please note that EmergingMed maintains its own privacy policy and EmergingMed utilizes a separate online account registration to store clinical trial results. • Fill out one questionnaire and within seconds you'll know if your profile matches any clinical trials in our system. The EmergingMed database contains more than 3,000 clinical trials for treatment, prevention and early detection of cancer. The order in which match results are displayed does not reflect that any clinical trial is better or more appropriate for you than any other match listed. • If you want more information about one or more clinical trials, you can ask that an American Cancer Society Cancer Information Specialist contact you by phone or by email. They can also connect you at your request to the doctors and nurses conducting the trials that you have matched. Read more
    101. 101. • Updated: 12/18/2001 Related Pages: Search for Clinical Trials NCI's PDQ® database of cancer clinical trials. User's Guide for PDQ® Clinical Trials Search User's guide for the Physician Data Query (PDQ) clinical trials database, explaining contents, how to use the database (including search techniques), comprehensiveness, and how to utilize results. About the PDQ® Editorial Boards Description of the PDQ editorial boards.
    102. 102. • Welcome to TrialCheckSM, Version 1.0 • The Coalition of National Cancer Cooperative Groups is proud to offer TrialCheckSM, a new Web-based application. TrialCheckSM gives doctors, nurses, patient advocates, and other healthcare professionals a "real-time" search tool that quickly queries and screens hundreds of cancer clinical trials. • TrialCheckSM provides nationwide locations where trials are open and enrolling patients. It's easy, customizable through the coordinator function, and will soon be portable in PDA format. TrialCheckSM helps physicians screen trials for their patients. TrialCheckSM enables advocates to be more effective in providing specific trial information to people who call their organizations.
    103. 103. How Do We Proceed?
    104. 104. MCC Collaboration: Measuring Clinical Trial Enrollment in Michigan • Champion importance of study with research investigators and managers – intervening with those who do not respond to the survey – Health system members – Michigan Health and Hospital Association • Continue to Seek Financial Support to Complete Project – MSHO
    105. 105. MCC Collaboration: Addressing Physician Bias • Educate our medical colleagues about the benefits of referring their patients to physicians & institutions that participate in cancer clinical trials. – Michigan Association of Health Plans & Individual Payers – Michigan Academy of Family Physicians – Michigan Osteopathic Association – Michigan Primary Care Association – MSHO – Michigan State Medical Society • Enhance the recognition, visibility, and credibility of those physicians & institutions that participate in cancer clinical trials – MCC Award
    106. 106. MCC Collaboration: Addressing Physician Bias • Highlight participation in Clinical Trials as a Quality Indicator for Providers and Institutions – Recognition of American College of Surgeons Research Standards – Health Plans and Purchasers of Healthcare should be encouraged to use clinical trial participation as a benchmark for program excellence
    107. 107. MCC Collaboration: Influencing Patient and Family Attitudes • Educate cancer patients and their families about the benefits of participating in clinical trials • ACS • Health Departments • Michigan Association of Health Plans & Individual Plans • Cancer Information Service – Train the Trainer • ONS • Michigan Academy of Family Physicians • Michigan Dietetics Association • Michigan Primary Care Association – Work with Patient Advocacy Groups to insure awareness of Michigan Clinical Trial Issues
    108. 108. MCC Collaboration: Influencing Patient and Family Attitudes • Engage Media/Public Press – Identify and develop partnering opportunities with pharmaceutical companies using their marketing, education and funding resources. – Use editorial boards, local contacts in print, radio & TV • ACS • Healthcare Systems – Public Relations Departments • Health Plans – Marketing Departments
    109. 109. MCC Collaboration: Resolving Insurance Coverage Issues • Promote awareness of the Guidelines to providers, payers and purchasers of healthcare. – BCBSM – HAP – MAHP – MSHO – Michigan Working Group to Improve Cancer Outcomes • Inclusion of Phase I trials, Prevention and Screening Trials in the Guidelines – Michigan Working Group to Improve Cancer Outcomes
    110. 110. MCC Collaboration: Resolving Insurance Coverage Issues • Long term organization and funding of the Michigan Working Group to Improve Cancer Outcomes – MSHO – Pharmaceutical Industry Grants – Health Plan/Industry Foundations • A mechanism to review promising trials that do not fall within the “deemed” status criteria • Development of a registry of current “deemed” clinical trials in Michigan
    111. 111. MCC Collaboration: Collaborating with Minority Community Thought Leaders to Increase Clinical Trials of Underrepresented Populations • ACCESS • Faith Access to Community Economic Development • Healthy Asian Americans project • Inter-Tribal Council of Michigan • National Association of Hispanic Nurses
    112. 112. MCC Collaboration: Expanding Access and Infrastructure Support to Community Physicians • Contribute to the growth of CCOPs and Networks • Promote Awareness and Access to Resources for Community Physicians to Participate in Trials • Support Research Managers’ Networking Opportunities – MSHO – MDCH
    113. 113. Clinical Trial Action Plan Modifications • Extend Goal Deadline to 2006 • Modify Workplan – Dedicated Michigan Clinical Trial Registry may be satisfied with collaboration/modification of ACS and other registries. – Professional Education efforts to be revisited
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