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
(No Transcript)
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
(No Transcript)