“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

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.

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.

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.pdf

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/proceedings2/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

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

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.

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.

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.

Health Policy Arm

Objectives:1) assess policy issues related to

underrepresented populations’ participation in oncology and asthma clinical trials;

2)2) To host a National Policy Roundtable To host a National Policy Roundtable Meeting to create a policy agendaMeeting to create a policy agenda;

3) Conduct dissemination activities involving policy education and advocacy

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

Methodology: Meeting Development & Facilitation

What accelerates Change?• Purpose• Shared Strategy• Leadership• Critical Mass• Roadmap• Infrastructure• Sustaining Momentum

Whole-ScaleWhole-Scale®® Change Changeinternational trademark of Dannemiller Tyson Associatesinternational 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" 

Converge/Diverge Model for Sustaining Whole-Scale® Change

Whole-ScaleWhole-Scale®® Change Change

Large Group Work Large Group Work Large Group Work

Small Group Work Small Group Work

Methodology: Methodology: Meeting Development & FacilitationMeeting Development & Facilitation

©Dannemiller Tyson Asso, 2000

Roadmap for ChangeRoadmap for Change(Converge/Diverge)(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/Checkpoint

Event

Event Planning

Team

Plan - Do - Check - Act

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.pdf

• 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

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

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