Sixth National Conference on Quality Health Care for Culturally Diverse Populations: Main Conference Concurrent Workshops Eliminating disparities in clinical trials
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C-3 Increasing minority participation in clinical trials

Eliminating disparities in clinical trials
Tuesday, September 23, 2008: 2:00 PM-4:00 PM, Minn Marriott, 4th Floor - Pine/Cedar/Birch
Clinical trials are a critical resource for developing new life-saving drugs as well better prevention, diagnostic, and treatment methods.  However, people with low income, the elderly, racial/ethnic minorities, women and those who live in rural areas represent the smallest percentage of clinical trial participants.  Unfortunately, these same populations also bear a disproportionate burden of disease.  The result is often that clinical research does not assess how treatments may differently affect members of different populations.  Consequently:
  • The scientific quality of clinical research is lowered.
  • The financial cost of clinical research is increased as it takes more time, effort, and money to recruit and retain adequate numbers of participants.
  • Ultimately, social justice is not served as the fruits of biomedical research are not equitably distributed.
The EDICT (Eliminating Disparities in Clinical Trials) Project was developed to design practical and realizable policy solutions to disparities in clinical trial participation.  Specifically, EDICT:
  • Brings together representative stakeholders from the public, private, and non-profit sectors to develop policy recommendations that comprehensively address disparities in clinical trials.
  • Emphasizes a systems approach to identifying both the root causes of disparities and the critical policymakers who can address them.
  • Communicates policy recommendations to the widest possible audience using a creative and pro-active dissemination model.
Housed in the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine, EDICT is a collaboration of over 300 medical researchers, healthcare professionals, patient advocates, public health officials, and pharmaceutical company representatives.  Nine working groups have developed over 30 policy recommendations in the following areas:
  1. Reinvigorating regulation & policy related to disparities in clinical trials
  2. Collaboration with the pharmaceutical industry
  3. Fostering community involvement in clinical trials
  4. Involving biomedical publications in setting standards for inclusion in clinical trials
  5. Professional education for researchers, health care professionals, and members of Institutional Review Boards (IRBs)
  6. Reallocating research funding to avoid duplication and address disparities
  7. Enhancing public and community education about clinical trials
  8. Navigation and support for individuals in clinical trials
  9. Assuring insurance coverage (private insurance, Medicare, Medicaid, and SCHIP) for costs of participating in clinical trials
This presentation will describe these recommendations plus several complementary EDICT Dissemination Projects.  These include implementing the Department of Health and Human Services (DHHS) Office of Minority Health’s National Standards for Culturally and Linguistically Appropriate Services (CLAS) as well as other evidence based policies, practices, programs, and projects to reduce clinical trials disparities.

Presentation Information:

Program: Main Conference Concurrent Workshops


Cynthia Spiker, MPH , Chronic Disease Prevention and Control Research Center, Baylor College of Medicine, Houston, TX
    Instructor of Medicine
    Baylor College of Medicine
    Chronic Disease Prevention and Control Research Center
    1709 Dryden, Suite 10.25
    Houston TX, USA 77030

    Phone: 713-798-4615
    Fax: 713-798-3990
    Email Address: cspiker@bcm.edu

    Biographical Sketch:     Cynthia Spiker, MPH is the Project Manager of the Policy Research Arm of the Eliminating Disparities in Clinical Trials (EDICT) Project. Launched in 2005, the EDICT initiative is a research study designed to address the problems and find workable solutions to recruiting and retaining populations that are underrepresented in clinical trials such as low income, elderly, racial-ethnic minorities or those who live in rural areas. Recognizing that medically underserved populations have the lowest rates of participation in clinical trials, EDICT is focusing on two critical components – policy and intervention research – to remedy this inequality in representation. Conducted by the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine in collaboration with the Intercultural Cancer Council (ICC), this four-year project is funded through an unrestricted educational grant from Genentech, Inc. She began her career at Baylor College of Medicine in 1975 as Project Manager of the Secondary and University Education Section, Education Division, of the National Health and Blood Vessel Research and Demonstration Center. The Education Division evolved into the Chronic Disease Prevention and Control Research Center, where she continued developing public and continuing medical education programs applying proven biobehavioral research models to all chronic diseases. In 1986, she became Health Education Manager at CIGNA HealthCare of Texas, directing wellness and disease management programs and overseeing quality and accreditation for preventive medicine activities. In 2000, she returned to the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and became an instructor in the Department of Medicine.
Larry Laufman, Ed.D. , Chronic Disease Prevention & Control Research Center, Baylor College of Medicine, Houston, TX
    Associate Director for Educational Development
    Baylor College of Medicine
    Chronic Disease Prevention & Control Research Center
    1709 Dryden - Suite 1025
    Houston TX, USA 77030

    Phone: 713-798-5387
    Fax: 713-798-3990
    Email Address: llaufman@bcm.edu

    Biographical Sketch:     Dr. Laufman is an Assistant Professor and Associate Director for Educational Development in the Chronic Disease Prevention and Control Research Center, in the Department of Medicine at Baylor College of Medicine in Houston, Texas. His work includes research, demonstration, and program evaluation projects in health and medical education targeting the public, patients and their families, medical students, physicians, and other health care professionals. He has been involved with the Eliminating Disparities in Clinical Trials (EDICT) project for the past three years and is currently Project Director for a related project, Culturally and Linguistically Appropriate Services And Clinical Trials (CLAS-ACT). The EDICT CLAS-ACT Project provides background resources as well as a self-study for investigators and institutions to assess how well they implement CLAS standards in clinical trials and other research studies. A second project is the EDICT BackPack Project, which collects and makes available evidence based and promising policies, practices, programs, projects, and other resources in support of eliminating disparities in clinical trials. Both CLAS-ACT and BackPack have been funded by the DHHS Office of Minority Health. Dr. Laufman Co-Directs a cancer prevention elective course at Baylor, where he is also a group facilitator for the medical problem solving and medical ethics courses. Since 1998, he has been a site visitor for the Subcommittee for Continuing Medical Education Accreditation of the Texas Medical Association. Previous activities have included a city wide cholesterol screening of 33,000 individuals over 10 days during February “Heart Month”; local and international HIV/AIDS prevention and treatment studies, and consulting with community based organizations on program development and evaluation. Dr. Laufman began his career in health education in 1977 as a research assistant in the Education Division of the DeBakey Heart Center at Baylor College of Medicine. During that time he also worked in the Research and Evaluation Department of the Houston Independent School District. After receiving his doctorate in Foundations of Education from the University of Houston in 1983, he was an Associate in Medical Education and an Instructor in the Department of Surgery at the University of Texas Medical Branch at Galveston. He joined the Baylor College of Medicine faculty in 1987. From 1989-1993, he coordinated the Stop-Smoking Program of the Institute for Preventive Medicine at The Methodist Hospital in Houston, where he is currently a member of the Professional Advisory Group for the Clinical Pastoral Education Program.
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