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Clinical Trials: Building Partnerships to Improve Cancer Outcomes

Michigan Cancer Consortium Update

April 21, 2004

The major advancements in cancer prevention and clinical treatment are the

result of clinical research.

Cancer Clinical Trials

• Advance scientific knowledge

• Avoid useless treatment

• Offer options to those who have not responded to standard treatment regimens

• Reporting and analysis of adverse events improve care

ASCO’s Definition of Clinical Trials

• “Clinical investigation in oncology is hypothesis-driven research that employs measurements in whole patients or normal human subjects, in conjunction with laboratory measurements as appropriate, on the subjects of clinical biology, natural history, prevention, screening, diagnosis, therapy or epidemiology of neoplastic disease.”

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

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


Phase II = DOES THE DRUG DO WHAT IT’S SUPPOSED TO DO?

• Test effect on a single type of cancer

Slightly larger # patients (30 - 50) than Phase I trialPatients 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


Phase III = IS THE NEW DRUG A BETTER ALTERNATIVE TO CURRENT PRACTICE?

• Last step in testing• Randomized controlled trials that determine how a

new treatment compares with the current, standard treatment (Participants are randomized into 2 groups:standard of care vs. new treatment

Require large #’s patients (100’s or 1000’s)-- conducted thru many settings nationwide

1997

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

U of M and MSHO Convene the Clinical Trials Action Plan Committee

• Karmanos Cancer Institute• Henry Ford Health System• 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

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”

Implementation Plan

• Establish a mechanism to measure clinical trials participation

• Reduce physician and/or provider bias

• Resolve insurance coverage issues

• Collaborate with minority agencies to increase diversity

• Influence patient attitudes• Advocate for

improvement in clinical trial design and eligibility

• Expand access and infrastructure support to community physicians

• Support efforts by accrediting bodies to include clinical trial participation criteria

Establishing a Mechanism to Measure Michigan Patients and Providers Participation in Clinical Trials

Clinical Trials Enrollment Pilot

– Collaboration among Michigan Public Health Institute, MCC Clinical Trials Action Plan Committee, MSHO, MDCH and Michigan Working Group to Improve Cancer Outcomes members.

Current Project Leader: Sandra Herman, Ph.D

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

Need for a pilot study

• Baseline data are critical

• No single source of enrollment data

• Goal to increase enrollments in clinical trials

Who participated?

• Target population– Universities– Hospitals– Cancer centers– Community Clinical Oncology Programs

(CCOPs)

• 53 eligible institutions identified

Pilot Study Results

Figure 1. Gender of Persons Enrolled

Unknown13%

Male37%

Female50%

Figure 2. Ethnicity of Persons Enrolled

83.1%

14.6%2.4%

0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%

100.0%

White Black All other

Figure 3. Ages of Persons Enrolled

2.8%

24.0%

51.4%

16.6%

0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%

100.0%

15-29 30-49 50-69 70 +

Figure 4. Erollment by Sponsor Type

NIH55%Intramural

26%

Industry19%

Moving Forward – Funding the Next Phase

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

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

Data Sources

• CDUS/CTES data– Studies reporting data as part of Cancer

Therapy Evaluation Program– No additional reporting on these trials

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

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

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

2004 Time Line

• August– Final follow-up on data submissions– CDUS data received for 2001, 2002, 2003

• September– Preparation of report

Changes in 2004 Study

• Clinical trials utilizing Cancer Therapy Evaluation Program do not need to report

• Online data collection available

Addressing Physician Bias

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

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

MSHO Clinical Trials Assessment Sample Questions (Strongly Agree to Strongly Disagree)

1. My practice is limited by the hospital or HMO formulary.

2. Hospital policy dictates some of my treatment options.

3. Protocols do not include all patients and are therefore too restrictive.

4. My income is adversely affected by placing patients on clinical trials.

5. Protocols do not always include what I consider standard therapy.

6. I am concerned about being audited by insurers who exclude payments for clinical trials.

7. Other responsibilities prevent me from learning what I need to know to place patients on clinical trials.

8. Protocols require a large increase in time spent on each patient.

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

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.

Reasons Patients Do or Do Not Enroll in Cancer Clinical Trials

DO ENROLL: DO NOT ENROLL:• Perceive their needs not

physician’s priority• Disrupt quality of life, functional

abilities• Anxiety about randomization • Worry might not receive best

treatment• Concern about logistical difficulties• Perceive insurance problems • Concern about excessive toxicity• Poor understanding of study• Family against study participation• Worry about excessive burden on

family/friends

Trust in their physician

Physician recommended study

Physician responsive to questions and issues

Encouragement by family

Manageable side effects

Altruism

Desire to live

Albrecht,T. Ruckdeschel et al 2003

– Accrual more likely when MD:• reviewed items in informed consent document, was

supportive, responsive and reflective

• discussed benefits, side effects, patient concerns and resources to manage concerns

Physicians using both legal/info and social influence strategies enrolled

more patients

Albrecht, T, Ruckdeschel et al 2003

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

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

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

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

Categories of Approval

Network Cancer Program (NCP)

NCI-designated program (NCIP) Comprehensive Cancer Program

Teaching Hospital Cancer Program (THCP)

Community Hospital Comprehensive Cancer Program (COMP)

Community Hospital Cancer Program (CHCP)

Hospital Associate Cancer Program (HACP)

Affiliate Hospital Cancer Program (ACP)

Integrated Cancer Program (ICP)

Freestanding Cancer Center Program (FCCP

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

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.

Conclusions

To improve accrual to cancer trials we should 1. Enhance the recognition, visibility, and credibility of

those physicians & institutions that participate in cancer clinical trials

2. Educate the public about the benefits of participating in clinical trials

3. Educate our medical colleagues about the benefits of referring their patients to physicians & institutions that participate in cancer clinical trials

Conclusions

4. Develop more trials – adjuvant & non-adjuvant that serve males and disease sites other than breast

5. Offer all trials to appropriate, good performance status elderly patients

6. Work with our ethicists, IRB’s, and behavioral experts to structure our presentation of clinical trials, including “consent forms” to take advantage of the importance of “doctor influence” and “altruism” and to better present the scope of “positive” and “negative” effects of investigational treatments

Industry Generated Patient Education

Insurance Industry Publications

Cancer Information Service Clinical Trials Train the Trainer

Program

Using Media

• Publication inserts• Editorial Boards• Key local contacts for

press, radio and TV• Advertising

Resolving Insurance Coverage Issues for Those Enrolled in Clinical

Trials

The Issue

• The expansion of quality clinical research needed to improve cancer outcomes is impeded by patients’ and providers’ reluctance to participate in trials without assurance of health plan coverage.

The Dialogue Begins

March 5, 1999

Cancer Clinical Trials: Building Partnerships for the Future

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.

“Cooperation not legislation offers the greatest advantage to

Michigan’s cancer patients.”

The Honorable John J. H. Schwarz, M.D.

Michigan Working Group to Improve Cancer Outcomes

The Economic Alliance for Michigan

Prostate Education & Support Network

What Did Payers Say About Clinical Trial Coverage Prior to 2000?

“Manage the benefit!”

• View all trials as “investigational”• Build the infrastructure for denial

Carver – Michigan Working Group Meeting February 23, 2000

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


• Educated medical directors

• Enlightened administrators

• Educated patients• Educated physicians

Solution=Barrier Removal


Consensus Guidelines for Coverage of Routine Patient Care Costs for Those

Enrolled in Clinical Trials

Michigan Working Group to Improve Cancer Outcomes

Executive GroupPhilip Stella, MD

Mary Malloy

Tom Simmer, MD Sam Silver, MD Marshall Katz, MD

Gene Farnum

Carolyn Schmit, RN

Bob Chapman, MD

Mike Rosenberg, MD Carol Callaghan

Sue Haviland

Aaron Scholnick MD Noah Smith Chris Goeschels RN

Beverly Blaney, MD Ellen Sprental-Nakervis

Charles Schiffer, MD Chuck Gayney

Laura Champagne

Joe Carver, MD

Bruce Carl, MD MBA Jim Ball Sheldon Schwartz Ed Ervin Oliver Kim

Prostate Education& Support Network

The Economic Alliance for Michigan

Clinical Trials Costs/Responsibilities Model

• Administrative Costs (TrialSponsor)

• Investigative Agents (Pharmaceutical Company)

• Routine Patient Care Costs (Insurer/Accounts)

• Exceptional Tests (Trial Sponsor)

Payer Issues and Restraints

• Contract language

• Extrapolation

• Fiduciary responsibility

• Moral responsibility

• Cost

Insurers’ Perspective

Traditional Experience

• Insurer paid for routine care because system could not identify services 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


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


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

Key Elements of the Consensus Guidelines

• Voluntary agreement• Rigorous patient

protection safeguards are addressed

• Peer review scrutiny of trial design for therapeutic benefit & scientific validity is required

• Coverage applies to Phase II and Phase III

• Off Protocol use of any protocol is not covered under this agreement

• Coverage includes costs associated with routine patient care, delivery of the investigational agent or service and adverse effects

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.


Implementing the Guidelines

• Insurers cover routine costs of medical services delivered in clinical trials.

• Insurers override payment edits for off-label and unproven indications when members are enrolled in clinical trials.

• Off protocol delivery of investigational treatment remains beyond scope of coverage


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


Insurers’ PerspectiveBenefits

• 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


MAHP Clinical Trials Resource Packet to

Primary Care Physicians

Collaboration with Minority Agencies to Increase Diversity

Exploratory Meeting/ African American Thought Leaders

• MDCH identifies and invites prominent African American leaders to meet with the directors of Michigan’s research programs.

• Feasibility of a “Blue Ribbon” advisory panel will be proposed

for collaboration on strategies to resolve insufficient minority participation in clinical research.

• Group initially convened by MDCH, December, 2000

Improving Cancer Outcomes of African Americans In Michigan

Presented by: E. Yvonne LewisMichigan Cancer Consortium Board Meeting

April 21, 2003Lyon Meadows Conference Center

New Hudson, MI

Project Overview

• February 15, 2002

– Minority Enrollment Work Group of the Michigan Cancer Consortium provided an overview of the concept for a project to “Increase African American Participation in Cancer Clinical Trials”

– Concept was intended to have statewide impact, involving five large communities

– A total of 1,147,375 African Americans resided in these counties, constituting 81.3% of Michigan’s black population

Identified Communities• Detroit (Wayne County)

• Flint (Genesee County)

• Lansing (Ingham County)

• Saginaw (Saginaw County)

• Pontiac (Oakland County)

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.

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

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

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

Data Collection

• Modified Behavioral Risk Factor Survey (BRFS)

• Specifically surveyed African Americans in 5 communities

• 2194 respondents – overall response rate 52.7%

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


• 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


• Margin of 2:1 – African Americans found it more difficult to

communicate about cancer

– Believe that early diagnosis means more time to worry

– More likely to have difficulty arranging transportation and childcare

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

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.

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.

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

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.

MarchApril May June July August September

SaginawMarchSchool

Principal’s Orientation

LansingMarch 18, 2004Lift Every Voice

Training

FlintMarch 31, 2004Family Reunion Implementation

Team Orientation

DetroitMid-May

City Council Town Hall Meeting

FlintMay 20& 21,

2004Faith Leaders

Training

SaginawJune 5, 2004

African American Health Expo

DetroitJune 12 & 13, 2004

Praise Fest

FlintAugust 21, 2004Family Reunion

LansingEarly- Sept.Straight Talk About Cancer

SaginawEssay Contest

LansingLift Every Voice Implementation

DetroitApril 21, 2004Parish Nurse

Training

Timeline

Project Staff

• Project Director• E. Yvonne Lewis, Executive Director

Faith Access to Community Economic Development

• Project Specialist• Latecia Matthews

• Community Design Team

• Community Liaisons

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

Expanding Access and Infrastructure Support to Community Physicians

Growth of CCOPs in Michigan

Kalamazoo CCOP

Beaumont CCOP

Creating Awareness of Advances in Clinical Trial Design & Research

Resources

• ABOUT THE CTSU The Cancer Trials Support Unit (CTSU) is a pilot project sponsored by the National Cancer Institute (NCI) 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)

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.










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)

PLEASE NOTE: Cooperative Group sites located within

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.










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)

PLEASE NOTE: Cooperative Group sites located within

• Assurances and IRB Registration

• Compliance Oversight

• Education

• Policy Guidance

• Quality Program Improvement

• Workshops

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

Locating Information on Current Trials

• 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

• Updated: 12/18/2001

Related Pages:Search 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.

• 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.

How Do We Proceed?

MCC Collaboration:Measuring Clinical Trial Enrollment in

Michigan• Champion importance of study with research

investigators and managers – intervening with those who do not respond to the survey

– Health system members

– Michigan Health and Hospital Association

• Continue to Seek Financial Support to Complete Project

– MSHO

MCC Collaboration:Addressing Physician Bias

• Educate our medical colleagues about the benefits of referring their patients to physicians & institutions that participate in cancer clinical trials.– Michigan Association of Health Plans & Individual Payers– Michigan Academy of Family Physicians– Michigan Osteopathic Association– Michigan Primary Care Association– MSHO– Michigan State Medical Society

• Enhance the recognition, visibility, and credibility of those physicians & institutions that participate in cancer clinical trials– MCC Award

MCC Collaboration:Addressing Physician Bias

• Highlight participation in Clinical Trials as a Quality Indicator for Providers and Institutions– Recognition of American College of Surgeons Research

Standards

– Health Plans and Purchasers of Healthcare should be encouraged to use clinical trial participation as a benchmark for program excellence

MCC Collaboration:Influencing Patient and Family

Attitudes• Educate cancer patients and their families about the

benefits of participating in clinical trials • ACS• Health Departments• Michigan Association of Health Plans & Individual Plans• Cancer Information Service – Train the Trainer• ONS• Michigan Academy of Family Physicians• Michigan Dietetics Association• Michigan Primary Care Association

– Work with Patient Advocacy Groups to insure awareness of Michigan Clinical Trial Issues

MCC Collaboration:Influencing Patient and Family

Attitudes• Engage Media/Public Press

– Identify and develop partnering opportunities with pharmaceutical companies using their marketing, education and funding resources.

– Use editorial boards, local contacts in print, radio & TV

• ACS• Healthcare Systems – Public Relations Departments• Health Plans – Marketing Departments

MCC Collaboration:Resolving Insurance Coverage

Issues• Promote awareness of the Guidelines to providers,

payers and purchasers of healthcare.– BCBSM– HAP– MAHP– MSHO– Michigan Working Group to Improve Cancer Outcomes

• Inclusion of Phase I trials, Prevention and Screening Trials in the Guidelines– Michigan Working Group to Improve Cancer Outcomes

MCC Collaboration:Resolving Insurance Coverage

Issues• Long term organization and funding of the Michigan

Working Group to Improve Cancer Outcomes– MSHO– Pharmaceutical Industry Grants– Health Plan/Industry Foundations

• A mechanism to review promising trials that do not fall within the “deemed” status criteria

• Development of a registry of current “deemed” clinical trials in Michigan

MCC Collaboration:Collaborating with Minority

Community Thought Leaders to Increase Clinical Trials of

Underrepresented Populations

• ACCESS

• Faith Access to Community Economic Development

• Healthy Asian Americans project

• Inter-Tribal Council of Michigan

• National Association of Hispanic Nurses

MCC Collaboration:Expanding Access and Infrastructure

Support to Community Physicians

• Contribute to the growth of CCOPs and Networks• Promote Awareness and Access to Resources for

Community Physicians to Participate in Trials• Support Research Managers’ Networking

Opportunities– MSHO

– MDCH

Clinical Trial Action Plan Modifications

• Extend Goal Deadline to 2006

• Modify Workplan

– Dedicated Michigan Clinical Trial Registry may be satisfied with collaboration/modification of ACS and other registries.

– Professional Education efforts to be revisited

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Documents

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