Margo Michaels, MPH

Executive Director, ENACCT

Co PI, Communities as Partners in Cancer Clinical Trials, R13-HS016471

Panel on Use and Implementation of EHC and EPC Research Products

September 10, 2008

Using EPC Reports to Promote Changes in Research, Practice

and Policy: A Perspective from Two NGOs

○The only national organization solely devoted to community-centered approaches to cancer clinical trials education.

○Dedicated to finding evidence based approaches that work to change attitudes, behaviors and ultimately, accrual.

2

About us…The only national organization devoted solely to promoting

health through partnerships between communities and higher educational institutions, including community-based participatory research

Conducts research & evaluation, provides training & technical assistance, convenes stakeholders, disseminates info

3

Community Based Participatory Research“Scientific inquiry …in which community members, persons affected by condition or issue under study and other key stakeholders … (are) full participants in each phase of the work – conception, design, conduct, analysis,interpretation, conclusions and communication of results.”

Definition of CBPR. Federal Interagency Working Group on CBPR. Retrieved 2007 from National Institute of Environmental Health Sciences Web site: http://www.niehs.nih.gov/translat/IWG/iwghome.htm

 

Evidence Report #99 Utilization of CBPR

can improve research quality, enhance intervention quality, improve outcomes, and enhance research recruitment efforts

Health

Concerns

Identified

Study

Designed

and

Funding

Sought

Participants

recruited and

retention

systems

implemented

Measurement

instruments

designed and

data collected

Intervention

designed and

implemented

C. helps

identify key

issues

Incr.

motivation

to

participate

C. helps with

study design,

budget,

proposal

submission

Incr.

acceptability

and “ buy - in ”

Issues

selected

Design: science

and feasibility

CommunityCommunity -- Based Participatory Research Based Participatory Research (from AHRQ evidence report on CBPR)(from AHRQ evidence report on CBPR)

C. gives

guidance re

recruitment

and retention

Enhanced

recruitment

and retention

C. helps with

measures

development

and testing

Increased

reliability and

validity

C. helps guide

intervention

development

Greater

relevance and

likelihood for

success

Intervention

designed by

Measures

adopted or

Recruitment and

Retention based

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Evidence Report #122

Uncertainty about effective approaches for cancer clinical trials recruitment

Need further investigation of effective communication and trust-building strategies

CBPR should be explored as a way to address persistent barriers

Awareness Barriers/Promoters

KnowledgeAttitudes/Beliefs

Self-EfficacyOrganizational Environment

Health Literacy

Opportunity Barriers/PromotersProvider Knowledge

Provider Attitudes/Beliefs

Eligibility/Exclusions by Design Access

Medical InsuranceAdvanced Disease

Co-morbidityOrganizational Environment

Acceptance/Refusal Barriers/Promoters

Perceived Harms/Benefits

Trust in Sponsor/Investigator

Self-efficacyAltruism

Religious BeliefsPersonal ExperienceNo Cost TreatmentFinancial Incentives

Timing

Opportunity

Awareness Acceptance/

Refusal

Use of the EPCs by our Respective Organizations: ENACCT Training

Community Leaders Community Health Care Providers Training of Trainers Program: “What do you see as the greatest barrier to CCTs in your community?”

Rationale for Grants Training Model

ENACCT’s 3-pronged training program Many barriers relate to lack of knowledge

and underlying attitudes and beliefs among patients, communities, primary care providers, oncology teams

In order to increase CCT participation, it is critical to enhance the knowledge, attitude, and skills of each of these groups

Use of the EPCs by our Respective Organizations: CCPH Evidence Report on CBPR:

2004: Disseminated report through CCPH website, listservs & newsletter (4000+ audience)

2004: Sponsored first teleconference on the report, featuring authors as speakers (300 attendees)

2005-2007: Incorporated findings into CBPR institutes at APHA and CCPH conferences (500 attendees)

2005-2008: Incorporated review guidelines into merit review for Healthier Wisconsin Partnership Program

2006: Incorporated findings into evidence-based curriculum, www.cbprcurriculum.info (2000+ hits)

Use of the EPCs by ENACCT & CCPH together: Rationale for Conference Grant Application to

AHRQNIH, NCI, IOM and the literature have called for the

inclusion of public representatives in research design and implementation to address low accrual and improve research outcomes

How can we leverage the findings of these two evidence reports into action recommendations that will lead to changes in design and implementation of Phase III treatment clinical trials?

A national strategic planning effort with core funding from the Agency for Healthcare Research and Quality and the National Cancer Institute (NCI).

Additional core financial support from The Lance Armstrong Foundation American Society of Clinical Oncology Genentech GlaxoSmithKline

Communities as Partners in Cancer Clinical Trials

Project Purpose

To bring together a diverse group of stakeholders to explore ways to improve Phase III cancer treatment trials, utilizing the principles & approaches of CBPR.

To develop a national strategic plan for research, practice & policy for incorporating CBPR principles & approaches into Phase III cancer clinical trials.

5 steps, 3 years

Report Release-9/30/08

1st report to detail how the cancer clinical trial process would involve communities affected by cancer– from trial design to implementation to dissemination of results - with a strong focus on community engagement and CBPR.

Seven Areas of Recommendation I. Ensuring a Meaningful Role for Community

Representatives/Patient Advocates in Trial Design II. Ensuring Community Perspectives in the IRB Review Process III. Improving the Informed Consent Process IV. Ensuring Community Perspectives in Protocol Development,

Trial Design and Implementation V. Improving Trial Participant Recruitment, Accrual and Retention VI. Enhancing Local Community Support for Cancer Research VII. Enhancing Community Interpretation, Dissemination and

Implementation of Trial Outcomes

Next Steps: Dissemination and Implementation

Sponsors: NCI and the pharmaceutical industry Those designing and implementing: The national

Cooperative Groups, industry, and local clinical research sites

Oversight and quality improvement agencies: FDA, OHRP, AHRQ, and local Institutional Review Boards

Accreditation organizations: Association for the Accreditation of Human Research Protection Programs and the American College of Surgeons’ Commission on Cancer

Thank You!

www.enacct.org

www.ccph.net