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Clinical Trials: Building Partnerships to Improve Cancer Outcomes

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Title: Clinical Trials: Building Partnerships to Improve Cancer Outcomes


1
Clinical Trials Building Partnerships to Improve
Cancer Outcomes
  • Michigan Cancer Consortium Update
  • April 21, 2004

2
The major advancements in cancer prevention and
clinical treatment are the result of clinical
research.
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
ASCOs 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
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 improve comfort and quality of life for
    cancer patients

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
Defining Clinical Trials Phases
  • Phase II DOES THE DRUG DO WHAT ITS 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
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
    groupsstandard of care vs. new treatment
  • Require large s patients (100s or 1000s)--
    conducted thru many settings nationwide

9
1997
  • Increase participation in cancer clinical trials
    selected as a priority of the MCC

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
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
Implementation Plan
  • 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
  • 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

13
Establishing a Mechanism to Measure Michigan
Patients and Providers Participation in Clinical
Trials
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
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
Need for a pilot study
  • Baseline data are critical
  • No single source of enrollment data
  • Goal to increase enrollments in clinical trials

17
Who participated?
  • Target population
  • Universities
  • Hospitals
  • Cancer centers
  • Community Clinical Oncology Programs (CCOPs)
  • 53 eligible institutions identified

18
Pilot Study Results
19
Moving Forward Funding the Next Phase
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
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
Data Sources
  • CDUS/CTES data
  • Studies reporting data as part of Cancer Therapy
    Evaluation Program
  • No additional reporting on these trials

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
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
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
2004 Time Line
  • August
  • Final follow-up on data submissions
  • CDUS data received for 2001, 2002, 2003
  • September
  • Preparation of report

27
Changes in 2004 Study
  • Clinical trials utilizing Cancer Therapy
    Evaluation Program do not need to report
  • Online data collection available

28
Addressing Physician Bias
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
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
MSHO Clinical Trials Assessment Sample Questions
(Strongly Agree to Strongly Disagree)
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
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
Reasons Patients Do or Do Not Enroll in Cancer
Clinical Trials
  • DO NOT ENROLL
  • Perceive their needs not physicians 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
  • DO ENROLL
  • 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
Physicians using both legal/info and social
influence strategies enrolled more patients
  • 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

Albrecht, T, Ruckdeschel et al 2003
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
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
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
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.

02-623
40
(No Transcript)
41
Categories of Approval

42
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

43
Influencing Patient and Family Attitudes
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.

45
Conclusions
  • To improve accrual to cancer trials we should
  • Enhance the recognition, visibility, and
    credibility of those physicians institutions
    that participate in cancer clinical trials
  • Educate the public about the benefits of
    participating in clinical trials
  • Educate our medical colleagues about the benefits
    of referring their patients to physicians
    institutions that participate in cancer clinical
    trials

46
Conclusions
  • Develop more trials adjuvant non-adjuvant
    that serve males and disease sites other than
    breast
  • Offer all trials to appropriate, good performance
    status elderly patients
  • 6. Work with our ethicists, IRBs, 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

47
Industry Generated Patient Education
48
Insurance Industry Publications
49
Cancer Information Service Clinical Trials Train
the Trainer Program
50
Using Media
  • Publication inserts
  • Editorial Boards
  • Key local contacts for press, radio and TV
  • Advertising

51
Resolving Insurance Coverage Issues for Those
Enrolled in Clinical Trials
52
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.

53
The Dialogue Begins
March 5, 1999 Cancer Clinical Trials Building
Partnerships for the Future
54
November 3, 1999Senator 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.

55
Cooperation not legislation offers the greatest
advantage to Michigans cancer patients.
The Honorable John J. H. Schwarz, M.D.
56
Michigan Working Group to Improve Cancer Outcomes
The Economic Alliance for Michigan
Prostate Education Support Network
57
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
58
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
59
SolutionBarrier Removal
  • Educated medical directors
  • Enlightened administrators
  • Educated patients
  • Educated physicians

Carver Michigan Working Group Meeting February
23, 2000
60
Consensus Guidelines for Coverage of Routine
Patient Care Costs for Those Enrolled in Clinical
Trials
61
Michigan Working Group to Improve Cancer
OutcomesExecutive Group
62
Clinical Trials Costs/Responsibilities Model
  • Administrative Costs (TrialSponsor)
  • Investigative Agents (Pharmaceutical Company)
  • Routine Patient Care Costs (Insurer/Accounts)
  • Exceptional Tests (Trial Sponsor)

63
Payer Issues and Restraints
  • Contract language
  • Extrapolation
  • Fiduciary responsibility
  • Moral responsibility
  • Cost

64
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
65
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
66
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

67
Key Elements of the Consensus Guidelines
  • 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
  • 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

68
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.

69
Insurers PerspectiveImplementing 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
70
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
71
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
72
MAHP Clinical Trials Resource Packet toPrimary
Care Physicians
73
Collaboration with Minority Agencies to Increase
Diversity
74
Exploratory Meeting/ African American Thought
Leaders
  • MDCH identifies and invites prominent African
    American leaders to meet with the directors of
    Michigans 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

75
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

76
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
    Michigans black population

77
Identified Communities
  • Detroit (Wayne County)
  • Flint (Genesee County)
  • Lansing (Ingham County)
  • Saginaw (Saginaw County)
  • Pontiac (Oakland County)

78
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.

79
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

80
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

81
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
    screening programs

82
Data Collection
  • Modified Behavioral Risk Factor Survey (BRFS)
  • Specifically surveyed African Americans in 5
    communities
  • 2194 respondents overall response rate 52.7

83
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

84
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

85
Preliminary Outcomes
  • Margin of 21
  • 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

86
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

87
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.

88
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.

89
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

90
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.

91
Timeline

Detroit April 21, 2004 Parish Nurse Training
Lansing Lift Every Voice Implementation
Saginaw Essay Contest
92
Project Staff
  • Project Director
  • E. Yvonne Lewis, Executive Director
  • Faith Access to Community Economic Development
  • Project Specialist
  • Latecia Matthews
  • Community Design Team
  • Community Liaisons

93
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

94
Expanding Access and Infrastructure Support to
Community Physicians
95
Growth of CCOPs in Michigan
  • Kalamazoo CCOP

Beaumont CCOP
96
Creating Awareness of Advances in Clinical Trial
Design Research Resources
97
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98
  • 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)

99
  • Assurances and IRB Registration
  • Compliance Oversight
  • Education
  • Policy Guidance
  • Quality Program Improvement
  • Workshops

100
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

101
Locating Information on Current Trials
102
  • 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   

103
  • Updated 12/18/2001Related PagesSearch
    for Clinical TrialsNCI's PDQ database of cancer
    clinical trials.User's Guide for PDQ Clinical
    Trials SearchUser'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
    BoardsDescription of the PDQ editorial boards.
     

104
  • 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.

105
How Do We Proceed?
106
MCC CollaborationMeasuring 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

107
MCC CollaborationAddressing 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

108
MCC CollaborationAddressing 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

109
MCC CollaborationInfluencing 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

110
MCC CollaborationInfluencing 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

111
MCC CollaborationResolving 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

112
MCC CollaborationResolving 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

113
MCC CollaborationCollaborating 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

114
MCC CollaborationExpanding 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

115
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

116
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