1. 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

2. ○ 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

3. 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

4. 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

5. Evidence Report #99  Utilization of CBPR can improve research quality, enhance intervention quality, improve outcomes, and enhance research recruitment efforts

7. 7 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

8. Awareness Barriers/Promoters Knowledge Attitudes/Beliefs Self-Efficacy Organizational Environment Health Literacy Opportunity Barriers/Promoters Provider Knowledge Provider Attitudes/Beliefs Eligibility/Exclusions by Design Access Medical Insurance Advanced Disease Co-morbidity Organizational 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 Opportunity Awareness Acceptance/ Refusal

9. 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

10. 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

11. 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)www.cbprcurriculum.info

12. 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?

13.  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

14. 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.

15. 5 steps, 3 years Laying the Foundation for CBPR in Cancer Clinical Trials (3/07-8/07 ) Convening 1 st of Two Invitational Meetings (9/2007) Developing Preliminary Draft Recs (11/07 – 2/08) Vetting and Refining Initial Draft Recs (3/08-8/08) Disseminating and Implementing Plan (9 /08 – 9/09)

16. Report Release- 9/30/08 1 st 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.

17. 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

18. 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

19. Thank You! www.enacct.org www.ccph.net