1. “Identifying Opportunities in Health Policy to Eliminate Disparities in Clinical Trials” Presented by: Tisha Fowler, M.S.W. Chronic Disease Prevention & Control Research Center Baylor College of Medicine, Houston, TX American Cancer Society Bridging the Health Care Divide Research and Programs to Eliminate Cancer Disparities Conference 2007

2. Presentation Objectives Identify barriers and facilitators to participation in clinical trials for underrepresented populations. Describe a process for identifying and prioritizing policy concerns related to clinical trials participation. Recognize important policy areas related to improving participation of underrepresented groups in clinical trials. Discuss the importance of equal access to clinical trials in the quality of life of cancer patients.

3. Background Among surveyed U.S. adults 15% ever had an opportunity to participate in a clinical research study, but only 10% ever participated (Harris Interactive, 2005) Cancer: Estimated 3-5% for adults compared to 60% for children (NCI) Review of Food & Drug Administration (FDA) approved drugs showed that racial/ethnic minorities collectively represented less than 15% of clinical trial participants (Evelyn et al., 2001) Federal mandates for National Institutes of Health in 1993 [Pub L. 103-43] & FDA in 1997 [Pub. L.105-33] requires women and minorities be included in clinical trials, yet minorities continue to be underrepresented in clinical trials, particularly cancer prevention and treatment trials.

4. Barriers & Facilitators to Clinical Trial Participation Taken from: Powe, N. (2003). Cultural Issues in the Retention of Minority Populations in Clinical Trials. In Increasing Diversity in Clinical Trials Health Disparities Symposium. National Institute of Allergies & Infectious Diseases, National Institutes of Health. Available at: http://www.niaid.nih.gov/healthdisparities/HDSYMPOSIUM/proceedings2/proceedings.pdfhttp://www.niaid.nih.gov/healthdisparities/HDSYMPOSIUM/proceedings2/proceedings.pdf

5. Barriers & Facilitators (cont). Barriers Participant –Mistrust/Fear –Lack of awareness –Sociocultural factors (beliefs, language etc) –Economic factors (insurance, childcare, etc) Institution –Lack of funds for appropriate recruitment Investigator –Study design issues –Ineffective staff communication Sponsor –Lack of investigator incentives –Bottom-line Facilitators Participant & physician educational efforts –Partnerships with community-based organizations –Working with primary care –Mass mailings –Targeted media Reduction of structural barriers –Providing childcare –Transportation Additional references: Powe, N. (2003). Cultural Issues in the Retention of Minority Populations in Clinical Trials. In Increasing Diversity in Clinical Trials Health Disparities Symposium. National Institute of Allergies & Infectious Diseases, National Institutes of Health. Available at: http://www.niaid.nih.gov/healthdisparities/HDSYMPOSIUM/proceedin gs2/proceedings.pdf http://www.niaid.nih.gov/healthdisparities/HDSYMPOSIUM/proceedin gs2/proceedings.pdf Knowledge and Access to Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials. Available at: http://www.ahrq.gov/clinic/epcsums/recruitsum.htm http://www.ahrq.gov/clinic/epcsums/recruitsum.htm

6. EDICT Project Project Purpose: To address problems and develop solutions related to increasing the participation of minority and other underrepresented patients in asthma and cancer clinical trials Project Arms: Field Demonstration Health Policy

7. EDICT Project Credo The following beliefs guide our work together: –All individuals will have the opportunity and necessary support to participate voluntarily in clinical trials for which they are eligible. –Participants and researchers will understand and promote the benefits of diversity in clinical trials. –Results from clinical research will benefit the participants’ communities and society at large.

8. Field Demonstration Arm To test the effect of various interventions on patient accrual and retention rates in cancer and asthma trials when applied to underrepresented participant/patient populations and to study recruiting physicians and staff, compared to no intervention.

9. Health Policy Arm To develop practical and implement able policy solutions to disparities in clinical trials through which change can occur at the federal government, state government, institutional levels; and/ or public, private or non-profit sectors.

10. Health Policy Arm Objectives: 1)assess policy issues related to underrepresented populations’ participation in oncology and asthma clinical trials; 2)To host a National Policy Roundtable Meeting to create a policy agenda 2)To host a National Policy Roundtable Meeting to create a policy agenda; 3)Conduct dissemination activities involving policy education and advocacy

11. Methodology: Participant Representation Structured Matrix Sector –Public –Private –Non-profit Specialization –Research –Clinician –Public Health –Advocacy Focus –Asthma –Cancer Invited 300 participants across the matrix Assigned “mixed” seating for small group discussion Qualitatively synthesized group suggestions into themes

12. Methodology: Meeting Development & Facilitation What accelerates Change? Purpose Shared Strategy Leadership Critical Mass Roadmap Infrastructure Sustaining Momentum Whole-Scale ® Change international trademark of Dannemiller Tyson Associates Reference: Blixt, AB & James, SL. Accelerating Strategic Change: Application of the Whole-Scale Approach to Leading and Managing Change. Learnende Organisation" January/February 2004 issue, Institut für Systemisches Coaching und Training, Vienna, Austria"

13. Converge/Diverge Model for Sustaining Whole-Scale® Change Whole-Scale ® Change Large Group Work Small Group Work Methodology: Meeting Development & Facilitation

14. ©Dannemiller Tyson Asso, 2000 Roadmap for Change (Converge/Diverge) Getting Started Event Planning Team Leadership Team Alignment Event Small Group Work Small Group Work Event Planning Team Organizational Alignment Event Special Purpose Work Leadership and Core Teams Support the Change Small Group Work Task Team Work Small Group Work Reunion/Check point Event Event Planning Team Plan - Do - Check - Act

15. Roundtable Meeting Results 143 attendees across sectors and specializations 9 policy theme areas Evaluation results: Attendees felt very confident that we would act on what we had committed to during the 2 day meeting; Attendees felt very confident project was in a position for success Full Evaluation available at: http://www.bcm.edu/edict/PDF/EDICT- 2006RoundtableMeetingEvaluationSummary.pdfhttp://www.bcm.edu/edict/PDF/EDICT- 2006RoundtableMeetingEvaluationSummary.pdf

16. Allocation of Research Funding Proportionate to Case Fatality Assuring Healthcare Coverage in Clinical Trials Education and Training - Institutional and Professional Education and Training - Public and Patients Fostering Community Input and Involvement and Relationships Patient/Participant Navigation Pharmaceutical Partnerships Publication-Related Policies Regulatory Oversight and Enforcement Roundtable Meeting Results: Policy Theme Areas

17. Sustainability: Current Progress Core Leadership Teams Development of recommendations for policy in theme areas WebEx Technology May 7-8, 2007 http://www.bcm.edu/edict/teams.html

18. Future Plans Development of dissemination plan Roll out of project results: Intercultural Cancer Council (ICC) biennial –April 3-6, 2008 For more information, please visit our website!! http://www.bcm.edu/edict