Clinical Trials Action Plan - the Michigan Society of Hematology and

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					 Michigan Cancer Consortium Initiative
      Clinical Trials Action Plan


“By the year 2005, double the number and increase the diversity of
        participants enrolled in clinical cancer research.”
                                  ACKNOWLEDGEMENTS

                             Clinical Trials Action Planning Group


Convening Agencies:

Samuel Silver, M.D., Ph.D.
Medical Director                            University of Michigan Cancer Center
                                            Network Initiative
Chairman, Committee on Practice             American Society of Hematology

Philip Stella, M.D.
President                                   Michigan Society of Hematology and Oncology
Principal Investigator                      Ann Arbor Regional CCOP

Mary Malloy
Executive Director                          Michigan Society of Hematology and Oncology


Collaborating Agencies

Carolyn Schmidt, R.N.
Research Director                           Josephine Ford Cancer Center, Henry Ford Hospital

Robert Chapman, M.D.
Medical Director                            Josephine Ford Cancer Center, Henry Ford Hospital

Victoria Rakowski
Vice President for Cancer Control           American Cancer Society, Great Lakes Division

Jeffery Letzer, D.O.                        Michigan Osteopathic Association

Ray Lord, M.D.
Principal Investigator                      Kalamazoo CCOP

Ellen Sprentall-Nankervis, Pharm.D.
National Accounts Manager                   Amgen, Inc.

Mary Noel, M.P.H., Ph.D., R.D.              MCC Colorectal Advisory Committee
Associate Professor                         Michigan State University, College of Human
                                            Medicine, Nutrition Services

Andrew Kelahan, Ph.D.
Executive Director                          Coalition of National Cancer Cooperative Groups
Collaborating Agencies (Continued)


Connie Szczepanek, R.N.
Administrative Director                 Grand Rapids CCOP

Timothy O’Rourke , M.D.
Principal Investigator                  Grand Rapids CCOP

Charles Schiffer, M.D.
Director of Clinical Research           Barbara Ann Karmanos Cancer Institute

Joan Westendorp, R.N., B.S.N., O.C.N.   Greater Kalamazoo Oncology Nursing Society
Director of Research and Education      West Michigan Cancer Center

Karen Denolf, R.N., B.S.N., O.C.N.      Oncology Nursing Society, Traverse Bay Region
Clinical Nurse Specialist               Munson Medical Center

Denise Ballard
Outreach Director                       NCI’s Cancer Information Service

Fred Lee, M.D.                          MCC Prostate Cancer Advisory Committee

Connie Alfaro, R.N.                     National Association of Hispanic Nurses


MCCI Staff

Margaret Beall, EMT, MPH
MCCI Staff Liaison                      Michigan Cancer Control Initiative
                                    Executive Summary

By the year 2005, double the number and increase the diversity of participants enrolled in
clinical cancer research

The major advancements in cancer prevention and clinical treatment are the result of clinical
research. Clinical trials provide the mechanism of transition from the laboratory bench to
bedside, compare current treatment options, and promote excellence in the practice of oncology.
Although the benefits of clinical research have been documented and promoted for years, the
enrollment statistics of those participating in trials continue to be abysmally low. Current data
indicates that only 2-3% of cancer patients are put on clinical trials. Despite efforts of the
National Cancer Institute and national patient advocacy groups to increase awareness of clinical
trials as possibly the best treatment option for a patient, the percentages stay the same. It has
been determined that increasing clinical research participation requires the active endorsement of
community medical providers, encouragement of local thought leaders and commitment from
payers and their accounts. The MCCI Clinical Trials Action Planning Group selected strategies
and initiatives that will encourage partnerships with all segments of the community that have a
vested interest in better cancer outcomes.

The Action Planning Group agreed to adopt the American Society of Clinical Oncology’s
definition of patient-oriented research which reads: “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.” Clinical trials may be government or private industry sponsored but must be peer
reviewed and IRB approved. NCI Cooperative Group trials, Comprehensive Cancer Center
trials, FDA-approved trials and academic center trials are included in our Action Plan.

Making the goal measurable and attainable requires establishing a baseline measurement.
Available data sources do not provide the information needed to evaluate the numbers and types
of trials that are currently ongoing in Michigan. The Pharmaceutical Research and
Manufacturers' Association (PhARMA) classifies pharmaceutical trial numbers “proprietary
information” and will not release them. While numbers from the NCI's Surveillance,
Epidemiology and End Results (SEER) data, the American Cancer Society (ACS) and other
national sources can be obtained; they fall short in providing the specific information necessary
to measure the progress of the MCCI initiative. Michigan’s “minority” and “under-served”
populations do not always coincide with the national designations. (i.e. the Arab community).
A well designed survey of Michigan physicians must be developed to identify current
participation in clinical cancer research and provide a monitoring mechanism so that immediate
benchmarks and long term progress can be evaluated.
To achieve the goal, The Clinical Trials Action Planning Group identified six major areas that
influence participation in clinical trials:
• Physician/Provider bias
• Patient/public attitudes
• Minority issues
• Trial design
• Access to trials
• Coverage issues
As identified in the problem statement, all these issues must be addressed to increase enrollment
in all types of clinical cancer research studies whether they are designed for cancer prevention,
treatment or supportive care.

On March 5, 1999, the Clinical Trials: Building Partnerships for the Future program was
held in Detroit. This forum was developed and supported by many members of our Action
Planning Group. (Coalition of National Cancer Cooperative Groups, American Cancer Society,
Michigan Society of Hematology and Oncology, University of Michigan Cancer Center,
Karmanos Cancer Institute, Amgen, and the Cancer Information Service) The purpose of this
initiative was to begin a dialogue among providers, payers, patients and the public about
increasing enrollment in clinical research. Our “Selected Action Group Objectives” and
“Implementation Plan” strategies were confirmed and/or reformulated as a result of this
exchange.

This Clinical Trials Action Plan is the culmination of hours of identifying barriers (real or
perceived), exploring current national clinical trials initiatives that should be publicized and
promoted, reviewing models from other states that address clinical trials issues and adapting
them for Michigan and authoring plans for situations that are unique to Michigan or have yet to
be addressed in other areas.
                                          Problem Statement

The number of patients currently participating in clinical trials is woefully inadequate to answer
important clinical questions in a timely manner. We are experiencing an unprecedented
opportunity to make advances in cancer treatment and prevention given recent scientific
breakthroughs, but the transition from the laboratory to standard practice can only be achieved
by well designed, significantly representative clinical research. The number of cancer patients
who are recruited to treatment clinical trials is estimated to be 2 –3% of those diagnosed.
Tracking participation in cancer prevention and screening trials is not currently possible, but
most agree that the percentage of the general population enrolled is small. Minority
representation in all clinical research studies is even lower. National efforts are underway to
develop a credible strategy to improve participation in clinical trials but a local commitment to
increasing enrollment is the quickest and most effective method to advance clinical cancer
research.

Physician/Provider Bias
Physician biases may be the most important issue determining whether a patient enters a clinical
trial. Oftentimes the patient’s medical treatment staff are unfamiliar with available clinical trials,
unwilling to offer trials as possibly the best treatment option for the patient, and /or not willing to
devote the additional time it takes to explain the clinical research process. Convincing physicians
that a protocol represents the best treatment option for the patient is key. Rodger Winn makes
the case that patients will enroll when the physician believes that the trial is sound medically and
scientifically and that as “expert surrogate” he would be willing to personally participate in the
trial. 1

Community physicians are less likely to place patients on studies than their hospital-based
counterparts. Hospital physicians generally have better access to trials and may not have the
same time or infrastructure constraints of their community colleagues. Benson noted that there
were also differences in oncology specialties with 72% of medical oncologists seeking out a trial
compared to 53% surgical oncologists and only 38% of radiation oncologists.2 Radiation
oncologists were more likely to feel uncomfortable with clinical trials and had difficulty
following though with the prescribed treatment.

Fear of losing patients has been identified as a major obstacle to recruitment. This undoubtedly
holds true for both primary care to oncology referrals as well as referrals between oncologists.
Better efforts at educating potential referring physicians are needed to garner their support most
importantly for cancer prevention trials. Support from the primary care provider for a trial may
be essential in getting the patient’s cooperation especially in those instances when a patient seeks
an objective opinion from someone they trust.



1
  Winn RG, Obstacles to the Accrual of Patients to Clinical Trials in the Community Setting. Sem Onc 1994; 21(4
Suppl): 112-117).
2
  Benson AB III, Pregler JP et al, Oncologists Reluctance to Accrue Patients onto Clinical Trials in an Illinois
Cancer Center. J Clin Onc 1991; 9:2067-2075.
Patient and Family Attitudes
Another study revealed that up to 30% of potentially eligible patients refuse participation in a
study. Reasons cited include fear of toxicity, personal cost, being a “guinea pig” and
unwillingness to relinquish control.3 Patients and their families do not understand the nature of
clinical trials and the randomization process. In the Journal of the National Cancer Institute,
Swanson notes that "Patients' concerns are in three general categories: time and hassle involved
in participation, negative personal and family attitudes regarding clinical trials, and inadequate
evidence of benefits from trial participation. The most foreboding of these issues seem to be
time and effort involved, particularly waiting and travel time, interventions or side effects that
are seen as unpleasant and the belief that the clinical investigator is more concerned about the
trial than about the patient."4 Increased time and effort must be allotted to address the concerns
of eligible candidates and their family members if trial enrollment is to increase.

Minority Issues
Participation of under-represented minority populations is crucial to assessing the safety and
efficacy of new treatment in that population. Recruitment of minorities and the elderly lags far
behind that of the general population. Swanson's article (Attachment 1) details the barriers to
minority and community physician recruitment and participation in clinical trials. Difficulty in
recruiting minorities reflects those issues voiced by the other reluctant patients but also includes
social, cultural and economic barriers. Widespread fear and mistrust of the medical care system,
lack of access to health care in general, language barriers, lack of education, lack of
transportation, lack of access to a telephone may all contribute to low clinical trial enrollment
numbers.5

Trial Design
Taylor noted that over half of the physicians responding to a 1991 survey believed that protocols
were too rigidly designed and cited trial design as a reason for excluding patients from a clinical
trial.6 Narrow eligibility criteria limit the pool of available patients and necessarily restrict
applicability of the protocol results. In addition, excessive testing and follow up have made it
difficult for a patient to comply with a study as well as use health care resources unnecessarily.

Access and Infrastructure Support
Not all physicians have access to clinical trials. Surveys indicate that a significant number of
physicians are not affiliated with a clinical trial group. Historically, qualified and interested
researchers have not been able to access trials of a non-allied group.

In the AMA survey of physician opinion about clinical research, 75% cited bureaucratic or
logistical concerns for not placing patients on study.7 Other physicians’ surveys reflect similar
results and cite excessive physician time as an issue as well as insufficient support for follow up.

3
  Hunter CP, Fredlick RW et al, Selection Factors in Clinical Trials: Results from the Community Clinical Oncology
Program Physician's Patient Log. Cancer Treat Rep 1987;71:559-565.
4
  Swanson GM, Ward AJ, Recruiting minorities Into Clinical Trials: Toward a Participant-Friendly System. J Natl
Cancer Inst 1995;87:1747-59.
5
  Ibid
6
  Taylor KM, Margolese RG et al, Physicians' Reasons for Not Entering Eligible Patients in a Randomized Clinical
Trials of Surgery for Breast Cancer. N Engl J Med 1984; 310: 1363-1367.
7
  AMA Council on Scientific Affair’s Viability of Cancer Clinical Research. J Natl Cancer Inst 1991; 83:254-259.
Lack of adequate funding to cover the personnel and training costs of research nurses, data
managers and administrative staff is another concern. The true data management and regulatory
costs of placing a patient on a clinical trial are unknown.

IRB regulatory issues are necessary to insure ongoing informed consent and safety. Lengthy,
complex, intellectually challenging “informed consent” documents have been identified as a
major obstacle in placing patients on clinical trials. The detailed recitation of possible side
effects without regard to the likelihood of that side effect actually occurring is detrimental to true
“informed consent”. Witness the 13-15 page consent forms of some phase III trials including
three pages of risks associated with Tamoxifen and it is no wonder why recruitment is a problem.
Perhaps as much as half the cost of performing a study is due to developing an initial consent
form, approval of the amendments and early updates, as well as reporting of adverse drug
reactions.

Coverage
Third party payers routinely reimburse clinical trial patient care costs. The current “don’t ask,
don’t tell” policy keeps physicians fearful of audits and patients concerned that none of their care
will be covered. While insurance companies acknowledge that participation in clinical trials is
necessary and can even be a quality indicator, they have real concerns regarding incremental
costs and lack of systems to track patients on studies.

Managed care organizations may deny coverage for experimental treatments outright, or in the
case of capitated contracts, put the onus on the physician and health care system making them
decide between a promising but expensive new drug or breaking the pharmacy bank. In a survey
by the Quality Assurance Review Committee, Robert Mechanic noted that half of the
respondents reported a decease in phase II and phase III studies as a consequence of entry of
managed care organizations into their market.8 Loss of patients was related to cost containment,
fewer referrals, an increase in fragmented care, and limitations on care out of network.




8
 Mechanic RE, The Impact of Managed Care on Clinical Research: A Preliminary Investigation. Health Affairs;
15: 72-89.
                           Proposed Action Group Objectives

The Clinical Trials Action Planning Group identified the following objectives and strategies that
should be addressed to increase enrollment and diversity of participants in clinical trials.

Physician/ Provider Bias
 • Physician Education Effort
    1. Grand Rounds presentations at local hospitals
    2. Physician mentoring program for those willing to participate in trials
    3. Mentoring for fellows and residents
   4. Support for physician attendance at research meetings
 • Feedback
   1. Update referring physicians on their patient’s progress
    2. Make available results of local trials
• Increase Incentive
   1. Develop trials that are testing the best treatment alternative
   2. Peer recognition
   3. Payer recognition as a “Center of Excellence” and priority referral.
   4. Recognition by accrediting agencies as an indicator of a quality cancer program

Patient Attitudes
• Patient/Family Education Effort
   1. Work with Advocacy Groups/Hotlines for Updated Information
   2. Community Outreach Programs
   3. Research Program Speakers Bureau
   4. NCI's Cancer Clinical Trials Education Program (CCTEP) " Train the Trainer" Program
• Media Campaign for General Public
• Support Systems for Patients Considering Trials
   1. Peer-to-peer program
   2. Convince patients that they now have an additional group of caregivers
   3. Address misinformation about trials and progress with consent simplification, redundant
       testing etc.
• Web site for Patients Currently Enrolled or Considering Trials
   1. Link with PDQ, ACS, CCOPs, Oncology Nursing Society (ONS), Cancer Care and other
       related sites

Minority Issues
• Work with Minority Group Leaders
  1. Identify best methods to reach group. (health fairs, group presentations, printed
      materials, cable TV shows)
  2. Identify spokespersons for credibility in the minority community
• Educate Minority Physicians on Their Role in Recruiting Clinical Trial Participants
• Encourage Input of Minority Physicians in Trial Design
• Utilize NCI Minority Education & Recruitment Tools
•   Research Staff Must Be Culturally Aware
    1. Language and comprehension barriers
    2. Economic and other resource constraints (transportation, telephone access)
    3. Distrust of medical system
•   Link Compatible Screening Initiatives with Title XV Programs

Trial Design
• Standardize and Simplify Consent Forms
• Develop Common Toxicity Criteria
• Develop Electronic Monitoring Systems
• Standardize End Point and Response Criteria
• Develop Common Data Reporting and Follow Up Forms
• Develop Common Guidelines and Systems for Cooperative Groups

Access and Infrastructure Support
• Survey to Measure Access
   1. Develop instrument to measure Michigan physician participation
   2. Poll academic medical centers, community clinical oncology programs (CCOPs)
   3. Enlist MI pharmaceutical representatives to get their trial numbers
• Encourage Physicians to Join CCOPs or Other Networks
• Open Access to Non-Allied Clinical Trials
• Utilize NCI Clinical Trial Support Unit System
• Partner with Pharmaceutical Companies for Nurse’s, Clinical Research Assistants (CRAs)
   Training
• Promote Community Nurses’ Awareness and Interest in Protocols

Coverage Issues
• Education Effort for Payers and Their Accounts
   1. All patient care costs should be covered (Per incremental cost studies)
   2. Participation in clinical research is a continuous quality control indicator (Cancer Center
      of Excellence)
   3. Physicians participating in clinical research should be designated “preferred providers”
• Expand the Specified Oncology Clinical Trial (SOCT) Blue Cross Blue Shield Rider
• Exert Public Pressure for Coverage
   1. Partner with advocacy groups
   2. Media campaign
   3. Work with community thought leaders and employers
• Support the NCI's Office of Cancer Research Promotion (OCRP) efforts with the Health Care
   Finance Administration for Medicare Coverage
• Educate & Lobby Legislators
• Work with the MI Insurance Commissioners Office
• Seek Legal Remedies as Last Resort
• Support Ongoing Efforts to Identify True Incremental Patient Care Costs
• Increase NCI and Other Funding Support for Data and Regulatory Costs
• Identify Other True Costs of Doing Study and Seek Reimbursement
                                Knowledge of Effective Interventions

    Physician/Provider Bias
    • The American Society of Clinical Oncology has surveyed all of its members in regards to
       their participation in clinical trials. The results of this January 1999 survey will be
       presented this spring. This comprehensive survey addresses physicians' perspectives on
       clinical trials, role in clinical trials, current experience, training in oncology research,
       patient reactions to clinical trials and other factors influencing participation in trials. The
       statistical information from this survey will provide an overview of areas of physician
       education and incentives that must be pursued.


    Patient Attitudes
    • The National Cancer Institute's "Cancer Clinical Trials Education Program" (CCTEP) is a
       comprehensive collection of teaching tools that groups customize to target different
       audiences in a variety of settings and addressing specific learning objectives. (Attachment
       2) This program increases access to current, accurate information about cancer clinical
       trials among potential participants, assists health professional in conducting the
       "informed consent" process, enables consumers and cancer patients to work with their
       health professionals to determine if a clinical trial is a good choice for them. CCTEP is
       also designed to raise public awareness and understanding of cancer clinical research and
       its relevance to today and tomorrow's cancer patients. This series has been successfully
       piloted in four Cancer Information Service (CIS) regions.
    • Advocacy groups such as Cancer Care and the American Cancer Society have developed
       publications and web pages for potential clinical trial participants to offer reassurance and
       information.
    • The National Cancer Institute has rewritten its "Taking Part in Clinical Trials: What
       Cancer Patients Need to Know" brochure and is currently redesigning its PDQ web site to
       make clinical trials information more accessible and encouraging.


    Minority Issues
    • The Eastern Cooperative Oncology Group conducted a study to identify the barriers and
      solutions to African American accrual into clinical trials and published its findings in the
      Journal of Clinical Oncology. The study concluded that National Medical Association
      physicians, who serve a significant sector of the African American population,
      demonstrated a willingness to cooperate in efforts to increase clinical trial enrollment. 9
      The importance of forging alliances with NMA physicians was discussed. Minority
      community outreach will be achieved by increased communication, consultation and
      follow up with these physicians. (Attachment 3)




9
 McCaskill-Stevens W, Pinto H J, Recruiting Minority Cancer Patients into Cancer Clinical Trials: A Pilot Project
Involving the Eastern Cooperative Oncology Group and National Medical Association. Clin Oncol 1999; 17:1029-
1039.
     • The Swanson and Ward article, "Recruiting Minorities Into Clinical Trials", offers a
       complete overview of issues and barriers surrounding minority recruitment.10 The article
       offers strategies for more successful trial design and stresses the need for support for
       participants and community staff involvement.(Attachment 1)
Trial Design
• The Report of the National Cancer Institute Clinical Trials Implementation Committee was
   presented to the NCI Board of Scientific Advisors on September 23, 1998. This exhaustive
   study reviewed and suggested strategies for thirteen major topics related to overcoming
   barriers to patient-oriented research. Creating uniform informatics systems across clinical
   research projects, reducing administrative and operational redundancy and flexible allocation
   of funding so that available resources are used efficiently to complete the best studies are a
   focus of this report. Pilot studies are currently being used to test key components of this
   report. (Attachment 4)


Access and Infrastructure Support
• The Report of the National Cancer Institute Clinical Trials Implementation Committee
   addresses the infrastructure and access concerns listed in our problem statement. Mechanisms
   to permit broad patient access to protocols and offering an "open menu" of Phase III trials
   available to all qualified investigators and patients are all supported in this report.
   (Attachment 4)
• A Clinical Trials Support Unit (CTSU) is a web-based system being developed by the NCI to
   increase access to clinical trials. Initially, selected Phase III lung, breast, GU, GI and adult
   leukemia trials will be targeted. The CTSUs will be responsible for protocol distribution,
   registration and communication of randomization, collection of on-study data and follow up
   forms, and eventually auditing.
• Ongoing pharmaceutical studies are currently being performed and funded through clinical
   research organizations working with individual practices or hospitals.
• Bristol-Myers Squibb Oncology offers a "Cancer Research Coordinator's Workshop" for
   research staff with two or less years of cancer research experience. The objectives of this
   one-day program are to explain and utilize an oncology protocol, present two processes for
   protecting research subjects and to discuss requirements for documentation. This program
   has been presented twice in the Washington DC area and the evaluations were very good.


Coverage
• Rhode Island, Maryland, Georgia and Virginia all currently have legislation on the books to
   cover patient care costs of those participating in a clinical trial. (Attachment 7)
• Efforts are now in progress to attach a clinical trial amendment to the Patient's Bill of Rights.
   Senator Frist has introduced this amendment requiring an Institute of Medicine study to:
   investigate factors that hinder participation, study the ability of health plans to distinguish
   between routine patient care costs and costs associated with clinical trials, study the impact
   of patient care costs on health care premiums, recommend how to increase patient

10
  Swanson GM, Ward AJ. Recruiting Minorities into Clinical Trials: Toward a Participant-Friendly System. J Natl
Cancer Inst 1995;87:1747-59.
    participation in trials, recommend how to encourage collaboration between public and private
    sectors, and recommend how to improve analysis of determining routine costs associated
    with the conduct of trials.
•   The Coalition of National Cancer Cooperative Groups has successfully worked with major
    insurance carriers (United Health Care, John Deere Health Care) to have patient care costs
    covered for Phase III clinical trials.
•   An agreement has been drafted between the American Association of Health Plans and the
    National Institute of Health for support of clinical trials. This document encourages plans to
    "reimburse the routine patient-care costs associated with NIH-sponsored trials, provided
    those costs are not substantially higher than the costs a plan would incur in the course of
    standard treatment."
•   Studies at Kaiser of Northern California, Group Health of Puget Sound and Mayo Clinic
    have all showed a non-significant incremental cost of covering patients on clinical trials. The
    objectives of the current Rand Study (1500 patients) are to answer the policy question: "How
    much would an insurer expect to pay to allow a beneficiary access to cancer trials?" and to
    estimate the marginal cost of trial participation.
•   In New Jersey, a collaborative effort among large insurance companies, both indemnity and
    managed care, government and cancer advocacy agencies has formed the state-sponsored
    "Working Group to Improve Clinical Outcomes". This group's mission is to "reach
    consensus between insurers, health care providers and patients regarding reimbursement of
    routine patient care expenses of approved cancer clinical trials".
                      Current Programs and Initiatives in Michigan

Measurement
• The 1999 Survey of ASCO members' Participation in Clinical Trials will be presented in
  May, 1999.

Physician/Provider Bias
• Ongoing efforts by Academic Medical Centers (AMCs) and Community Clinical Oncology
   Programs (CCOPs) to inform community physicians of the benefits of clinical trials
• AMCs and CCOPs support sending physicians to research meetings
• The American College of Surgeons (ACoS) currently requires institutions with more than
   750 cancer patients to have a minimum of 2% of them enrolled in studies for accreditation.

Patient Attitudes
• AMCs and CCOPs continue to efforts to inform patient populations of the benefits of
   participating in clinical trials
• Initial NCI Cancer Clinical Trial Education Program (CCTEP) training sessions have begun

Minority Issues
• Current minority trial recruitment efforts are offered through the CCOPs, funded by the NCI,
  using the NCI's minority education and recruitment tools.

Trial Design
• AMCs and CCOPs are developing studies that offer good science while being doable in a
   community practice setting.
• The AMCs and CCOPs are following NCI trial design mandates:
   1. Simply consent form
   2. Make Inclusion criteria less restrictive and more representative of “real world” patients
   3. Make more studies available to research sites

Access and Infrastructure Support
• Michigan is home to four Academic Medical Centers including two of only 32 National
   Cancer Institute-designated Comprehensive Cancer Centers.
   1. The University of Michigan Cancer Center, a NCI designated comprehensive cancer
       center, has more than 200 cancer clinicians and researchers working together in
       multidisciplinary teams to rapidly bring new prevention, detection and treatment
       discoveries to more than 25 cancer care clinics. U of M Cancer Center has formal
       affiliations in Radiation Oncology with Providence Hospital, Southfield, Foote Hospital,
       Jackson and Ingham Regional Medical Center, Lansing. U of M Cancer Center has
       CGOP affiliations with Foote Hospital, Saginaw General and a private oncology practice
       in Port Huron. U of M Cancer Center is a Co-investigator in a cancer epidemiology
       research project with the Henry Ford Health Care System and Co-investigator with
       Providence Hospital in a cancer palliative care study.
   2. The Barbara Ann Karmanos Cancer Institute is a continuum of research, patient care,
       education and community outreach. A designated comprehensive cancer center, the
       Karmanos Cancer Institute conducts basic research, clinical research, clinical care,
        community research and education in five programs of emphasis: breast cancer, cancer
        control: epidemiology & environmental carcinogenesis, experimental & clinical
        therapeutics, genitourinary cancer and tumor progression & metastasis. The Karmanos
        Cancer Institute operates 260,000 square feet of laboratory and clinical space. Treatment
        is available at the Detroit campus as well as Huron Valley - Sinai Hospital. The Institute
        is also affiliated with North Oakland Medical Center, Pontiac and St. Mary's Hospital,
        Livonia.
    3. Doctors at Henry Ford Hospital and Ambulatory Care Centers are actively involved in
        clinical trials. The Josephine Ford Cancer Center offers a majority of cancer services
        through four cancer centers located about 20 minutes from any patient's home in
        southeast Michigan. (Detroit, New Center, Downriver, West Bloomfield and Clinton
        Township) In addition there are three more regional sites for chemotherapy services in
        Dearborn, Harper Woods and Northwest Detroit.
    4. The Cancer Center at Michigan State University (CCMSU) research program includes
        pediatric oncology studies, palliative care programs, treatment trials and cancer
        prevention and control studies. The MSU Cancer Treatment Consortium has been
        conducting research into cancer therapy and today includes 92 physicians and 30
        hospitals in 10 communities around Michigan including most of the state's rural and
        farming regions. The Cancer Prevention and Control Program at the CCMSU
        encompasses three general areas: prevention and early detection of cancer, home care and
        family caregiving for cancer patients and their families and the economic burden of
        cancer on patients and their families.
•   Michigan currently has three Community Clinical Oncology Programs (CCOPs). A CCOP is
    a research program funded by the National Cancer Institute designed to combine the
    expertise of community physicians with ongoing cancer research.
    1. The Grand Rapids Community Clinical Oncology Program (GRCCOP) serves more than
        29 counties in West Michigan. GRCCOP is funded by the NCI and a consortium of
        seven acute care hospitals: Blodgett Memorial Medical Center, Butterworth Hospital,
        Holland Community Hospital, Metropolitan Hospital, Munson Medical Center - Traverse
        City, and St. Mary's Hospital. The GRCCOP is also affiliated with Battle Creek Health
        System and Mecosta County General Hospital.
    2. The Ann Arbor Regional Community Clinical Oncology Program currently includes five
        component hospitals: St. Joseph Mercy Hospital - Ann Arbor, St. John Hospital and
        Medical Center, St. Joseph Mercy - Oakland, Genesys Regional Medical Center, and
        Hurley Medical Center. The Ann Arbor CCOP's regional research base is located at the
        Mayo Cancer Center but also works with a number of cooperative groups to secure
        broad-based research consortium links with the most current research activities in all
        areas of cancer treatment around the country.
    3. The Kalamazoo Community Clinical Oncology Program is a consortium of Borgess
        Medical Center and Bronson Methodist Hospital. These hospitals serve as a cancer
        referral centers for the nine-county southwest Michigan area. There are currently more
        than 100 clinical trials for all types and stages of cancer available to physicians
        participating in the Kalamazoo CCOP.
•   Michigan CCOPs and Academic Medical Centers are building networks with community
    physicians that can provide access to innovative treatment and prevention strategies. These
    networks will increase clinical trial participation by connecting with existing structures.
•   In June 1999 Bristol-Myers Squibb Oncology will offer its Cancer Research Coordinator
    Workshop in Grand Rapids and Livonia. This initiative will be promoted by the Michigan
    Society of Hematology and Oncology through its Outpatient Oncology Nurse Network,
    newsletter and web page. There is no enrollment cost to the attendee or the research
    programs for staff members new to research or considering participation.

Coverage
• The Michigan Society of Hematology and Oncology is working with ASCO, the Association
   of Community Cancer Centers (ACCC), Karmanos Cancer Institute, U of M Cancer Center
   and the Coalition of National Cancer Cooperative Groups to develop an Oncology Benefits
   Package that Blue Cross Blue Shield of Michigan can present to its accounts as the standard
   for oncology coverage. Coverage of patient care costs for clinical trials is included in this
   package.
• The Clinical Trials Work Group of the Michigan Society of Hematology and Oncology is a
   standing committee that represents all of the academic medical centers and community
   clinical oncology programs in Michigan. This group was formed to monitor clinical trial
   initiatives in Michigan including educational programs, pending applicable legislation and
   economic studies.
• The March 5, 1999 Clinical Trials: Building Partnerships for the Future program began a
   dialogue between providers, payers, patients and the public on the necessity of increasing
   enrollment in clinical research and the importance that resolution of coverage issues plays in
   clinical trial participation.
                               Selected Action Group Objectives

Measurement
• Develop a survey instrument that would establish both a baseline and success indicator
  measurement of clinical trials’ participation in Michigan.
• Use this instrument as a baseline and success indicator measurement of minority enrollment
  in clinical trials.

Physician/Provider Bias
• Organize an education effort designed to reach all specialties that treat cancer patients
   including medical students, residents, and fellows and attending physicians.
• Encourage all researchers to increase feedback and follow up reporting to referring
   physicians.

Patient Attitudes
• Support “Train the Trainer” and other CCTEP initiatives to raise public awareness of the
   need for clinical research.
• Develop a patient web site that would list Michigan physicians participating in trials and
   offer a list of available studies. This page should link to PDQ and patient advocacy clinical
   trials information web sites.
• Develop a multi-media advertising campaign promoting participation in clinical trials.
• Work with advocacy group “hotlines” to insure information about all Michigan clinical trials
   is updated and accurate.

Minority Issues
• Work with minority health care providers to increase their participation in trial design issues,
  patient recruitment and follow up.
• Establish covenants with community leadership to increase minority group enrollment.

Trial Design
• Support and promote the work of the NCI Clinical Trial Implementation Committee.
• Fully leverage the strengths of the pharmaceutical industries as essential partners in the
   development of new anti-cancer drugs.

Access and Infrastructure Support
• Promote development of Research Networks for community practitioners. Build on
   infrastructure in place at Academic Medical Centers and CCOPs.
• Develop a web site for Michigan physicians to identify local trials and access further
   information including contact names and numbers.
Coverage
• Utilize existing models and initiatives to secure full coverage of patient care costs for clinical
   trials.
• Promote efforts to make clinical trial participation a cancer program quality indicator.
• Convene a “Clinical Trials Summit” with the major players from the provider, payer and
   patient advocacy communities.
• Work with state agencies to form a ”Michigan Working Group to Improve Clinical
   Outcomes for Oncology” based on the New Jersey model.
• Pilot a program with insurers and major employers to tie clinical trials to guidelines.
                                Implementation Plan
                            Clinical Trials Action Plan Group

              By the year 2005, double the number and increase the diversity
                      of participants enrolled in clinical cancer research


Objective 1:        Establish a mechanism to measure cancer clinical trial participation

Strategy 1:         Develop a survey that would establish a baseline of current clinical trial
                    participation and serve as a success indicator measurement for increasing
                    enrollment.

Strategy 2:         Use the survey to as a baseline for both current minority clinical trial
                    participation and a success indicator measurement for increasing minority
                    enrollment.

Rationale:          It is impossible to establish a baseline measurement of clinical trial
                    participation with the existing reporting mechanisms. A survey tailored to
                    reflect Michigan minority population enrollment and designed to
                    encompass all treatment, supportive care and prevention trials currently
                    active in our state is the best way to insure a credible evaluation of our
                    Action Plan goal. Monitoring the survey results and reporting the findings
                    to lead agencies of all components of the implementation plan will keep
                    the goal in focus.

Objective 2:        Increase enrollment in clinical trials by reducing physician/provider
                    bias

Strategy 1:         Organize an education effort designed to reach all specialties that treat
                    cancer patients including medical students, residents, fellows and
                    attending physicians.

Strategy 2:         All researchers should increase feedback and follow up reporting to
                    referring physicians. Cumulative results of studies as well as reports on
                    individual patients should be provided to the referring physician.

Rationale:          To insure that cancer patients in all Michigan communities have access to
                    clinical trials, physicians must be kept apprised of current research
                    opportunities, convinced of the value of participation and encouraged to
                    work toward increasing clinical trial enrollment. To encourage and
                    maintain physician buy-in to clinical trial referral, feedback on studies will
                    validate the effort the physician made to provide their patient with a
                    clinical trial option and continue the education process.
Objective 3:   Increase enrollment in clinical trials by influencing patient attitudes

Strategy 1:    The Cancer Information Service has access to and interest in a Cancer
               Clinical Trials Education Program “Train the Trainer” initiative. By
               having trained volunteers statewide, a consistent, well-supported program
               can be provided to any requesting group. The NCI has developed this
               program and provides corresponding educational materials to offer
               presentations for all audience levels.

Strategy 2:    Develop a patient web site that would list Michigan physicians
               participating in clinical trials, offer a list of available studies, offer general
               information for those considering participation, and link to related clinical
               trial web sites.

Strategy 3:    Develop a multi-media advertising campaign to promote participation in
               clinical trials.

Strategy 4:    Work with advocacy group “hotlines” to insure information about all
               Michigan clinical trials is updated and accurate.


Rationale:     A community education effort designed to emphasize the need for clinical
               research, address the public's concerns and misinformation and encourage
               enrollment in studies should be available in a number of formats.
               Michigan citizens concerned with advances in cancer should have access
               to information on all approved studies that are currently available for
               enrollment. Offering clinical trial information in a variety of formats (ad
               campaign, formal education presentations, and hotlines and web site) will
               result in broader awareness and influence.



Objective 4:   Increase the diversity of those enrolled in clinical trials by
               collaborating with minority community agencies and leaders.

Strategy 1:    Work with minority health care providers to increase their participation in
               trial design issues, patient recruitment and follow up.

Strategy 2:    Establish covenants with community leadership to increase minority group
               enrollment.

Rationale:     Minority physicians often serve and are most trusted by minority
               populations. By gaining the support of these physicians, minority
               recruitment will be facilitated. Social agencies working with minorities are
               well aware of the barriers that keep these populations from receiving state
               of the art health care. Enlisting the agency's recommendations for best
               reaching their targeted population and partnering with the agencies to
               compensate for language barriers, cultural taboos and socio-economic
               problems will establish trust and encourage research participation.


Objective 5:   Increase physician cooperation and participant enrollment by the
               disseminating information on trial design improvement.

Strategy 1:    Educating physicians and the public about the progress in trial design
               improvement will remove a major enrollment barrier. The
               recommendations of National Cancer Institute's Clinical Trial
               Implementation Committee (Attachment 4), the 1998 MARCH Clinical
               Trials Summit (Attachment 5) and the American Society of Clinical
               Oncology (Attachment 6) are rapidly being implemented on a local level.

Strategy 2:    By leveraging the strengths of the pharmaceutical industry as essential
               partners in the development of anticancer drugs, clinical trials can be
               better promoted, financed and enrolled.

Rationale:     Community physicians have been reluctant to commit to trial participation
               in part due to the demands on their limited time and resources. National
               efforts and achievements must be promoted at the local level to recruit
               community physician involvement. The resources of the pharmaceutical
               industry can support innovative programs to achieve this objective.

Objective 6:   Increase participant enrollment in trials by expanding access and
               infrastructure support to community physicians.

Strategy 1:    Promote the development of Research Networks for community
               practitioners.

Strategy 2:    Develop a web site for Michigan physicians to identify local trials and
               access further information including contact names and numbers.

Rationale:     One of the charges of the NCI-Designated Comprehensive Cancer Centers
               is to increase the quality of cancer care throughout the Cancer Center's
               region. The placement of clinical trials in the community actively
               enhances patient care by providing the highest level of therapy as well as
               advancing the field of hematology and oncology. Giving physicians tools
               to access accurate and timely information on trials will assist in recruiting
               their participation.
Objective 7:   Increase participation in clinical trials by resolving insurance
               coverage issues

Strategy 1:    Utilize existing models and initiatives to secure full coverage of patient
               care costs for clinical trials
Strategy 2:    Promote efforts to make clinical trial participation a cancer program
               quality indicator. Convince payers that clinical trial participation is a
               continuous quality improvement initiative.

Strategy 3:    Convene a "Clinical Trials Summit" with major players from the provider,
               payer and patient advocacy communities.

Strategy 4:    Work with state agencies to form a "Michigan Working Group to Improve
               Clinical Outcomes for Oncology" based on the New Jersey model.

Strategy 5:    Pilot a program with insurer and major employers to tie clinical trials to
               guidelines. Guidelines for best care should include access to a clinical
               trial for any patient who meets eligibility criteria. Academic Medical
               Centers payers and major employers can work together to review the
               utilization of protocols and guidelines in the community setting.


Rationale:     As evidenced in the March 5, 1999 Clinical Trials Forum: Building
               Partnerships for the Future, payers and providers are closing in on a
               workable agreement to reimburse patient care costs. Reimbursement is
               the linchpin in successful clinical trial recruitment efforts. Employers
               made the point that application of positive results from clinical trials rather
               than the coverage issue is their concern. Continuing this dialogue and
               mounting an ongoing provider education effort should prove successful in
               securing coverage for patient care costs.
                                                                                   Workplan


                                      Objective 1: Establish a mechanism to measure cancer clinical trial participation

Strategy and Lead                  Action Steps                      Resources           Responsible                    Milestones and Completion          Start   End
Agency                                                                                   Collaborative Agencies                 Indicator                  Date    Date
Develop a survey to       1. Hire a professional             Funding can be secured      AMCs and CCOPs (for                                               6/99    9/99
establish a baseline of   management group to develop,       through an unrestricted     survey input)
patients enrolled in      publish, distribute and compile    educational grant from
trials and measure        the survey.                        industry. Project total:    Data managers from
minority enrollment in                                       $17,000. ($5000 -' 99,      CCOPs to assist physicians
these trials./MSHO                                           $4000 - '00, $4000 - '01,   with enrollment numbers
                                                             $2000 - '02, $2,000 -'03)
                          2. Year one survey                 Mailing lists, letters      ASCO                         M =Baseline for hematologist and     9/99    12/99
                          hematologists and oncologists.     supporting project                                       oncologist clinical trial
                                                                                                                      participation determined
                          3. Year two all other oncology                                 MSTR/MRS                     M =Baseline for all cancer           9/00    12/00
                          specialties.                                                   GOS                          specialists' clinical trial
                                                                                         ACoS                         participation determined
                          4. year three add all physicians                               MAFP                         M = A clinical trials baseline for   9/01    12/01
                          who treat patients at risk for                                 MPCA                         ALL prevention, treatment and
                          cancer                                                                                      supportive care
Use survey as a           Survey all groups in 2002, 2003                                All of the above             C = participation doubled,           9/02    12/03
success indicator         to determine progress                                                                       minority enrollment number
                                                                                                                      increased
                                Objective 2: Increase enrollment in clinical trials by reducing physician/provider bias

Strategy and Lead               Action Steps                      Resources          Responsible                Milestones and Completion   Start   End
Agency                                                                               Collaborative Agencies               Indicator         Date    Date
Organize a physician   1. Develop a Speakers Bureau        MI Hospital Association   CCOPs                    M = data on numbers of        9/99    9/04
education              for Grand Rounds Presentations      (offer to members' CME                             presentations made
effort/AMCs                                                offices)                                           C = evaluation results
                       2. Enlist general medical and       Speakers Bureau (action   MSMS                     M = data on numbers of
                       specialty societies to include      step 1)                   AFP                      presentations made
                       research updates at their CME                                 MSTR                     C = evaluation results
                       programs.                                                     MSHO
Encourage ongoing      1. Provide referring physicians
communication          with follow up on their patients.
between researchers
and to referring
physicians/AMCs,
CCOPs
                       2. Provide results of studies to
                       physicians who have referred
                       patients.
                                      Objective 3: Increase enrollment in clinical trials by influencing patient attitudes

Strategy and Lead                  Action Steps                     Resources           Responsible                Milestones and Completion         Start   End
Agency                                                                                  Collaborative Agencies              Indicator                Date    Date
CCTEP Program/ CIS       1. Support "Train the Trainer"      NCI CCTEP manual and       MSHO Nurse Network       M = Speakers' roster increase       6/99    12/03
                         effort to expand available          materials                  ONS chapters             M = Presentations increase
                         professional community                                         AOSW chapters
                         speakers                                                                                C = Clinical trials awareness
                                                                                                                 increases (per program
                                                                                                                 evaluations)
                         2. Recruit volunteers from                                     ACS                      M = Speakers' roster increase       6/99    12/03
                         advocacy agencies to expand                                    LSA                      M = Presentations increase
                         available CCTEP trained                                        CLFM
                         community spokespersons.                                       KCI                      C = Clinical trials awareness
                                                                                                                 increases (per program
                                                                                                                 evaluations)
 Develop MI Clinical     1. List of all MI physicians who    NCI's PDQ                  AMCs, CCOPs              M = Counter registers hits to the   9/99    None
Trials Web Site/MCC      participate in trials                                                                   site.
                                                                                                                 M = Statistics can capture the
                                                                                                                 internet domains that have access
                                                                                                                 to the site.

                         2. List of all ongoing trials
                         (cross referenced)
                         3. Develop mechanism to keep        Educational grant from
                         site updated and neutral            industry. $5000 set up
                                                             $5000 annual maintenance
                         4. Link to all related clinical     PDQ
                         trial information                   ACS
                                                             Cancer Care
Multi-media clinical     1. Develop a campaign that is       Agencies may do work pro   OCRP                     M = Distribution of print pieces    9/99    None
trials awareness         culturally sensitive to increase    bono (i.e. Ad Council                               can be tallied.
campaign/ AMCs           minority enrollment.                work) or contacts in
CCOPs                                                        industry (Ford) may                                 M = other media outreach
                                                             encourage their ad                                  statistics can be tallied.
                                                             agencies to adopt this
                                                             cause.
                         2. Develop a campaign that
                         encourages patient to discuss a
                         clinical trial options with their
                         doctors.
Work with hotlines for   Education effort to make sure       1-800-4-CANCER             CIS
MI updates. /AMCs,       operators are aware of current      1-800-234-ACS1             ACS
CCOPs                    MI trials and issues
     Objective 4: Increase the diversity of those enrolled in clinical trials by collaborating with minority community agencies and leaders
Strategy and Lead              Action Steps                     Resources          Responsible                     Milestones and Completion      Start   End
Agency                                                                             Collaborative Agencies                    Indicator            Date    Date
Work with minority    1. Conduct focus groups to        Educational grants from    NMA                          M= Monitor minority recruitment   9/00    6/01
health care           address issues and encourage      industry                   MI Black Nurses Assoc.       on clinical trials survey
providers/AMCs,       recruitment                                                  ACCESS                       (see Objective 1)
CCOPs                                                                              Inter-tribal Council
                                                                                   Association of Hispanic
                                                                                   Nurses
                      2. Recruit minority physicians                                                                                              9/01    12/03
                      as spokespersons for clinical
                      trial enrollment
Establish covenants   Work with agencies to solve       Partnerships with          Michigan Neighborhood                                          9/99    none
with community        impediments to trial enrollment   government and private     Partnership
leadership./AMCs,     such as:                          social service agencies.   National Medical
CCOPs                 1. language and cultural                                     Association
                            barriers                                               Michigan Black Nurses
                      2. lack of transportation                                    Association
                      3. lack of childcare                                         Asian Pacific Organization
                      4. lack of healthcare                                        Healthy Asian Americans
                      5. no access to a telephone                                  Project
                                                                                   Arab-American and
                                                                                   Chaldean Council
                                                                                   Chaldean-Iraqi Association
                                                                                   of Michigan
                                                                                   Chaldean Federation
                                                                                   National Association of
                                                                                   Hispanic Nurses
                                                                                   Michigan Chapter, Latino
                                                                                   Family Services
                                                                                   Inter-Tribal Council of
                                                                                   Michigan
                                                                                   American Indian Health
                                                                                   and Family Services of SE
                                                                                   Michigan
                                                                                   Commission on Indian
                                                                                   Affairs
                                                                                   Indian Family Resources I
                                                                                   Michigan Urban Indian
                                                                                   Consortium
                                                                                   Office of Services to the
                                                                                   Aging - MDCH
                                                                                   Local "Area Agency on
                                                                                   Aging" Offices
                                                                                   AARP
      Objective 5: Increase physician cooperation and participant enrollment by disseminating information on trial design improvement

Strategy and Lead               Action Steps                     Resources         Responsible                 Milestones and Completion      Start   End
Agency                                                                             Collaborative Agencies                Indicator            Date    Date
Support and promote     1. Oncology research symposia    Grants from               MSHO                     M = Number of physicians          6/99    12/03
the work of the NCI's   directed towards community       pharmaceutical industry                            attending seminars
Clinical                physicians                                                                          M = Monitor patient recruitment
Implementation                                                                                              on clinical trials survey (see
Committee/AMCs                                                                                              Objective 1)
                        2. Incorporate information on                              MSHO
                        research trial design
                        improvements on agenda for
                        annual ASH and ASCO
                        Updates
                        3. Improve communication                                   CCOPs
                        with NCI and national research
                        bases to standardize and
                        simplify protocols
Partner with                                                                                                                                  Now     None
Pharmaceutical
Industry/AMCs,
CCOPs
         Objective 6: Increase participant enrollment in trials by expanding access and infrastructure support to community physicians

Strategy and Lead                  Action Steps                        Resources      Responsible                Milestones and Completion           Start    End
Agency                                                                                Collaborative Agencies              Indicator                  Date     Date
Recruit community         Already on-going                     1.  Core grants from                            1. Number of community               Present   None
practices into research                                            Comprehensive                                  practices forming these
partnerships with                                                  Cancer Centers                                 relationships
Comprehensive                                                  2. CCOP grants                                  2. Monitor patient recruitment
Cancer Center s and                                            3. Pharmaceutical                                  on clinical trials survey (see
CCOPs                                                          industry sponsorship                               Objective 1)
                                                                                                               3. Survey physicians for
                                                                                                                  adequacy of infrastructure
                                                                                                                  support
Develop Michigan          Piggyback efforts with Patient       Industry grants        AMCs                                                           9/99     none
Research web site for     web site (Objective 3)               NCI's PDQ              CCOPs
Community Physician
Use /MCC


                                Objective 7: Increase participation in clinical trials by resolving insurance coverage issues

Strategy and Lead                  Action Steps                        Resources      Responsible                Milestones and Completion          Start     End
Agency                                                                                Collaborative Agencies             Indicator                   Date     Date
Utilize existing models   1. Present results of incremental    Rand Study             NCI – OCRP                                                    3/5/99
and initiatives to        cost studies to payers and their     Mayo Study             ASCO                                                          Forum
secure full coverage      accounts.                            Kaiser Study
for patient care                                               Puget Study
costs/MSHO                                                     No $$$$
                          2. Continue to work with             No $$$$                CCOPs                    C = Contract agreements
                          CNCCG to foster relationships                               AMCs
                          with payers.
                          3. Continue work with BCBSM          No $$$$                ACCC                     M = Business plan completed           7/98     4/99
                          on Standard Oncology Benefits                               KCI
                          Package for clinical trial patient                          U of M                   C = BCBSM adopts for 1999                      9/99
                          care costs                                                  CNCCG                    contracts
                                                                                      ASCO
                          4. Work with BCBSM to                No $$$$                MI Insurance Bureau      M = All patient costs for               .
                          expand SOCT rider to include                                                         approved Phase III trials covered.
                          all approved clinical trials
                                                                                                               C = All approved clinical trials
                                                                                                               patient care costs are covered.
Promote efforts to        1. Work with BCBSM to                No $$$$                ASCO
make clinical trial       recognize those                                             NCI-OCRP
participation a quality   institutions/offices participating
indicator /AMCs,          in research as “Cancer Centers
CCOPs                     of Excellence” and “preferred
                          providers” for referral.
                          2. Encourage all cancer              No $$$$                      ACoS
                          program-regulating agencies to                                    NCQA (HEDIS)
                          require clinical research                                         ACCC
                          promotion for accreditation.                                      ASCO
Convene a “Clinical       1. Invite all major players from     Funding ($10,000)            AMCs                                3/00
Trials Summit”/           the provider, payer and patient      unrestricted educational     CCOPs
MSHO, MSMS, ACS           advocacy community.                  grants from industry.
                          2. Continue dialogue from
                          3/5/99 Forum.
Form “ Michigan           1. Select guest list, agenda         Initial meeting can be       MSHO
Working Group to          and timeline based on New            hosted by MSHO.              MSMS
Improve Clinical          Jersey model. Customize for          Subsequent meetings          MI Insurance Bureau
Outcomes for              Michigan issues.                     hosted on a rotating basis   Office of Medical Affairs,
Oncology” /AMCs,                                               by group members.            MDCH
CCOPs                     2. Ninety-day action plan for        No $$$$                      BCBSM
                          reaching a consensus on fair                                      Care Choices
                          reimbursement for clinical                                        HAP
                          trials.                                                           Total Health Care
                                                                                            M-Care
                          3. Group to determine a                                           Selectcare
                          mechanism for ongoing review                                      Blue Care Network
                          and discussion of issues                                          Community Choice
                                                                                            Michigan
                                                                                            Grand Valley Health Plan
                                                                                            Wellness Plan
                                                                                            Ultimed HMO
                                                                                            Health Plus of MI
                                                                                            Omnicare
                                                                                            Physician Health Plan of
                                                                                            Mid-Michigan
                                                                                            Omnicare
                                                                                            Cape Health Plan
                                                                                            Northmed HMO
                                                                                            Great Lakes Health Plan

 Pilot a program with     1. Incorporate clinical trials as                                 Ford Motor                   9/99   9/02
 providers and major      part of "best care" guideline for                                 BCSSM
 payers to tie clinical   eligible patients.
  trials to guidelines
   /AMCs, CCOPS
                                            Timeline

Since almost all of our strategies and action steps are ongoing efforts and many are tied to
national initiatives, the work has begun or will commence by September, 1999. The strategies
and action steps will continue until clinical trial enrollment is doubled and diversity of
participants is increased and then possibly beyond the stated goal.

1999
       3/99 Utilize existing models and initiatives to secure full coverage for patient care
       costs/MSHO
       • Present results of incremental cost studies to payers and their accounts.

       4/99
       • Continue to work with CNCCG to foster relationships with payers. MSHO
       • Continue work with BCBSM on Standard Oncology Benefits Package for clinical
          trial patient care costs, MSHO
       • Work with BCBSM to expand SOCT rider to include all approved clinical trials
          MSHO, AMCs

       4/99 Promote efforts to make clinical trial participation a quality indicator /AMCs,
       CCOPs
       • Work with BCBSM to recognize those institutions/offices participating in research as
          “Cancer Centers of Excellence” and “preferred providers” for referral.
       • Encourage all cancer program-regulating agencies to require clinical research
          promotion for accreditation.

       4/99 Partner with Pharmaceutical Industry/AMCs, CCOPs

       4/99 Recruit community practices into research partnerships with Comprehensive
       Cancer Centers and CCOPs

       4/99 Partner with Pharmaceutical Industry/AMCs, CCOPs

       6/99 Develop a survey tool to establish a baseline of patients enrolled in trials and
       measure minority enrollment in these trials, MSHO

       6/99 Initiate CCTEP Program/ CIS
       • Support "Train the Trainer" effort to expand available professional community
          speakers.
       • Recruit volunteers from advocacy agencies to expand available CCTEP trained
          community spokespersons.
6/99 Support and promote the work of the NCI's Clinical Implementation
Committee/AMCs
• Plan Oncology research symposia directed towards community physicians for 2000,
   MSHO
• Incorporate information on research trial design improvements on agenda for annual
   ASH and ASCO Updates, AMCs, MHSO
• Improve communication with NCI and national research bases to standardize and
   simplify protocols, CCOPs

6/99 Organize a physician education effort. AMCs
• Develop a Speakers Bureau for Grand Rounds Presentations. AMCs
• Enlist general medical and specialty societies to include research updates at their
   CME programs. MSHO

6/99 Encourage ongoing communication between researchers and referring
physicians/AMCs, CCOPs,
• Provide referring physicians with follow up on their patients,
• Provide results of studies to physicians who have referred patients.

9/99 Develop MI Clinical Trials Web Site/MCC
• List of all MI physicians who participate in trials
• List of all ongoing trials (cross referenced)
• Develop mechanism to keep site updated and neutral
• Link to all related clinical trial information

9/99 Develop Michigan Research web site for Community Physician Use /MCC
• Piggyback efforts with Patient web site

9/99 Survey hematologists and oncologists to establish baseline for clinical trial
participation determined, MSHO

9/99 Initiate a multi-media clinical trials awareness campaign/ AMCs CCOPs
• Develop a campaign that is culturally sensitive to increase minority enrollment.
• Develop a campaign that encourages patient to discuss a clinical trial options with
   their doctors.

9/99 Work with hotlines for MI updates. /AMCs, CCOPs
• Education effort to make sure operators are aware of current MI trials and issues

9/99 Establish covenants with community leadership./AMCs, CCOPs,
• Work with agencies to solve impediments to trial enrollment

9/99 Pilot a program with providers and major payers to tie clinical trials to guidelines
/AMCs, CCOPS.
• Incorporate clinical trials as part of "best care" guideline for eligible patients
       12/99 Finish collecting data on numbers of presentations made, evaluation results,
       MSHO

2000   1/00 Work with minority health care providers/AMCs, CCOPs Conduct focus groups to
       address issues and encourage recruitment

       3/00 Convene a “Clinical Trials Summit”/ MSHO, MSMS, ACS Invite all major players
       from the provider, payer and patient advocacy community.
       • Invite all major players from the provider, payer and patient advocacy community.
       • Continue dialogue from 3/5/99 Forum.

       3/00 Form “ Michigan Working Group to Improve Clinical Outcomes for Oncology”
       /AMCs
       • Select guest list, agenda and timeline based on New Jersey model. Customize for
          Michigan issues
       • Ninety-day action plan for reaching a consensus on fair reimbursement for clinical
          trials.
       • Group to determine a mechanism for ongoing review and discussion of issues

       9/00 Survey all oncology specialists to establish baseline for clinical trial participation,
       MSHO

       9/00
       • Work with minority health care providers/AMCs, CCOPs
                     •   Conduct focus groups to address issues and encourage recruitment

       •   10/0010/00 Oncology research symposia directed towards community physicians for
           2000, MSHO, amcs

2001   9/01 Survey ALL physicians who provide cancer prevention, treatment and supportive
       care to establish a baseline for clinical trials participation, MSHO,

       9/01 Work with minority health care providers/AMCs, CCOPs
       • Recruit minority physicians as spokespersons for clinical trial enrollment

2002   12/02 Survey all groups in 2002 to determine progress, MSHO

2003   12/03 Survey all groups in 2003 to determine progress, MSHO
       12/03 Participation doubled, Minority enrollment number increased

2004   9/04 Compile data on numbers of presentations made, present evaluation results
                                         Resource Plan
As the workplan indicates, the structure for our strategies and action steps is in place. Securing
funding for special initiatives like the survey and the web pages may delay the proposed start
date slightly but the committee is confident that pharmaceutical support should be easy to obtain.
Encouraging participation in clinical research serves the pharmaceutical industry well.

The Academic Medical Centers, the Community Clinical Oncology Programs, the Michigan
Society of Hematology and Oncology and the Michigan Cancer Consortium are identified as the
lead agencies for each strategy. These organizations have already shown their commitment to
this effort and have a vested interest in the goal. It is appropriate to approach these agencies to
take responsibility for the strategies listed and the committee expects that they will agree,
therefore recruiting time should not be an issue.

Academic Medical Centers (AMCs)
       Barbara Ann Karmanos Cancer Institute (KCI)
       University of Michigan Comprehensive Cancer Center (U of M)
       Henry Ford Health System (HFHS)
       Michigan State University Cancer Center (MSUCC)
These institutions must be involved in every initiative in this workplan.

Community Clinical Oncology Programs (CCOPs)
       Ann Arbor Regional CCOP
       Kalamazoo Regional CCOP
       Grand Rapids Regional CCOP
These institutions must be involved in every initiative in this workplan.

Michigan Society of Hematology and Oncology (MSHO)
As a co-convener of this Action Planning Group, MSHO has committed to facilitate the survey,
work toward coverage resolution and stage educational programs. MSHO will also participate
in securing pharmaceutical funding through its corporate members. All of these responsibilities
are in accord with the MSHO mission statement.

Michigan Cancer Consortium (MCC)
The Michigan Cancer Consortium will be asked to be responsible for the Michigan Clinical
Trials web site. Funding will be secured to pay for technical and clerical costs. The Action
Planning Group felt that it was important to have a neutral clearinghouse for this information.
Also the MCC web site for the planning initiative could be easily converted for this cause. MCC
can also serve as a conduit to involve the government and social agencies needed for specific
action steps.
National Cancer Institute (NCI)
        Office of Clinical Research Promotion (OCRP)
        Cancer Information Service (CIS)
        Clinical Trials Implementation Committee (CTIC)
        Physicians' Data Query (PDQ)
National efforts that are in progress provide the resources and structure for a number of our
workplan strategies and action steps. Personnel, publications and a network of expertise allow
many of our patient and provider educational efforts to be implemented with little delay. The
improvement in trial design and infrastructure support will have a direct impact on the success
of our enrollment efforts.


Coalition of National Cancer Cooperative Groups (CNCCG)
This organization is a leader in securing coverage for clinical trials. Supporting and promoting
their work is important locally. The CNCCG is a valuable resource for expertise and
networking,

Advocacy Groups
        American Cancer Society (ACS)
        Leukemia Society of America (LSA)
        Children's Leukemia Foundation of Michigan (CLFM)
        JP McCarthy Foundation
        Cancer Care
        Karmanos Cancer Institute (KCI)
The American Cancer Society and Cancer Care have educational resources that can be used in
our patient and professional education initiatives. (publications, web pages)
All the advocacy groups are potential sources of volunteers for the Cancer Clinical Trials
Education Program (CCTEP) and vehicles to endorse and promote educational efforts such as
the Clinical Trials Summit.
Payers
      Blue Cross Blue Shield of Michigan (BCBSM)
      Care Choices
      Health Alliance Plan (HAP)
      Total Health Care
      M-Care
      Selectcare
      Blue Care Network
      Community Choice Michigan
      Grand Valley Health Plan
      Wellness Plan
      Ultimed HMO
      Health Plus of MI
      Omnicare
      Physician Health Plan of Mid-Michigan
      Omnicare
      Cape Health Plan
      Northmed HMO
      Great Lakes Health Plan
      Ford Motor
      General Motors
      Steelcase
Support from the payer community is vital for the success of our goal. Recruiting these
companies to participate in forums, working groups and pilot programs will foster "buy in".

Michigan Government Agencies
       Michigan Department of Consumer and Industry Services - Insurance Bureau
       Michigan Department of Community Health
       Michigan Public Health Institute
These agencies give credibility to this effort as well as offer expertise, networking referrals and
empowerment.
Professional Medical Associations
        Michigan State Medical Society (MSMS)
        American Society of Clinical Oncology (ASCO)
        Association of Community Cancer Centers (ACCC)
        Michigan Academy of Family Physicians (MAFP)
        Michigan Primary Care Association (MPCA)
        Michigan Society of Therapeutic Radiologists (MSTR)
        Michigan Radiological Society (MRS)
        American College of Surgeons (ACoS)
        Gynecologic Oncology Society (GOS)
        Oncology Nursing Society (ONS)
        Association of Oncology Social Workers (AOSW)
Members of these Societies can be recruited for professional and public education efforts.
Endorsements from these groups are important for special education events and to support the
clinical trial participation survey. Having access to the mailing lists of these organizations will
be useful.

Pharmaceutical Partners
        Amgen
        Alza
        Bristol Myers Squibb
        Chiron
        Eli Lilly
        Genetech
        Genetics Institute
        Glaxo Wellcome
        Hoechst Marion Roussell
        Immunex
        Ligand
        Novartis
        Phamacia & Upjohn
        Rhone Poulenc Rorer
        Roche
        Schering
        SmithKline Beecham
Representatives from these companies are a great resource to promote the work of this action
planning group. They can secure the unrestricted educational grants needed for the survey,
special programs and the web pages. They distribute information about upcoming events and
can provide good feedback because of their community contacts.

Accrediting Agencies
       ACoS
       NCQA (Hedis)
       ACCC
Tying accreditation to enrollment numbers reaffirms clinical research as a continuous quality
indicator.
Minority Organizations
        Michigan Neighborhood Partnership
        National Medical Association (NMA)
        Michigan Black Nurses Association
        Asian Pacific Organization
        Healthy Asian Americans Project
        ACCESS
        Arab-American and Chaldean Council
        Chaldean-Iraqi Association of Michigan
        Chaldean Federation
        National Association of Hispanic Nurses
        Michigan Chapter, Latino Family Services
        Inter-Tribal Council of Michigan
        American Indian Health and Family Services of SE Michigan
        Commission on Indian Affairs
        Indian Family Resources
        Michigan Urban Indian Consortium
        Office of Services to the Aging - MDCH
        Local "Area Agency on Aging" Offices
        AARP
 Efforts to reach minority participants in trials can be best achieved with the input of the above
agencies. Professional organization and social and cultural agencies can define barriers and
suggest interventions. A "buy in" from these groups will increase enrollment of targeted
minorities




Organizations involved in implementation will keep the Michigan Cancer Consortium informed
of its effort to acquire additional funding for the implementation strategies. If appropriate,
organizations may collaborate with other partners and/or work in conjunction with the MCC to
develop funding for those objectives that are more cost-intensive and will require more time to
implement. The workplan included in this action plan contains more specific information about
resources, including estimates of resources needed and suggested potential sources, specific to
each objective and strategy.
                                           Evaluation
The MCCI Clinical Trials Action Planning Group's primary endpoint, as stated in the goal, is the
doubling of enrollment in clinical trials and increasing the diversity of those enrolled in studies.
The survey being developed should provide the measurement required.

Other measures of success:
• Numbers of community and professional volunteer trained for Speakers' Bureau
• Number of presentations on Clinical Trials given to the Community and recorded attendance
• Number of Grand Rounds presentations on Clinical Research and recorded attendance
• Number of physicians enrolled in Research Networks
• Statistics on ad campaign contacts
• Numbers accessing web site
                           Feedback and Internal Monitoring

Organizations responsible for coordinating the implementation of specific strategies will ensure
that there is a process to facilitate communication among the various responsible parties involved
with the implementation. Organizations will need to consider what information should be
communicated among implementation partners, how that information should be shared and how
frequently formal communication should take place.
                                    Progress Reporting

Organizations participating in implementation plan are expected to report progress indicators to
the Michigan Cancer Consortium. Implementers should develop a method for tracking and
reporting the progress toward the goal and milestones, and use the required reporting forms to
share that information with the MCC.

				
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