Margo Michaels, MPH

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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

• Margo Michaels, MPH
• Executive Director, ENACCT
• Co PI, Communities as Partners in Cancer Clinical
  Trials, R13-HS016471

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• 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.

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• 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

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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/iwghom
  e.htm
•  

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Evidence Report 99

• Utilization of CBPR can improve research quality,
  enhance intervention quality, improve outcomes,
  and enhance research recruitment efforts

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(No Transcript)
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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

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Opportunity Barriers/Promoters Provider
Knowledge Provider Attitudes/Beliefs Eligibility/E
xclusions by Design Access Medical
Insurance Advanced Disease Co-morbidity Organizati
onal Environment
Acceptance/Refusal Barriers/Promoters Perceived
Harms/Benefits Trust in Sponsor/Investigator Self-
efficacy Altruism Religious Beliefs Personal
Experience No Cost Treatment Financial
Incentives Timing
Awareness Barriers/Promoters Knowledge Attitudes/B
eliefs Self-Efficacy Organizational
Environment Health Literacy
Opportunity
Acceptance/ Refusal
Awareness
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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

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ENACCTs 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

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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)

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Use of the EPCs by ENACCT CCPH together

• Rationale for Conference Grant Application to
  AHRQ
• NIH, 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?

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Communities as Partners in Cancer 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

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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.

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5 steps, 3 years
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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.
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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

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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

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Thank You!

• www.enacct.org
• www.ccph.net