The Office of Special Populations and Research Training (OSPRT) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), hosted the health disparities symposium titled Increasing Diversity in Clinical Trials: Best Practices, at the Bethesda Marriott Hotel in Bethesda, Maryland, on Thursday, October 2, 2003. The symposium attracted approximately 150 attendees, representing a broad spectrum of disciplines in clinical trials research and practice.

The purpose of the symposium was to bring together clinical researchers, community physicians, nurse coordinators, community advisory board members, and other health care professionals with an interest in increasing the racial and ethnic diversity of participants in clinical trials. The symposium explored culturally appropriate methodologies in the outreach, recruitment, and retention of racial and ethnic minority participants in clinical trials.

The symposium objectives were to:

• Examine cultural issues that affect the recruitment and retention of minority participants in clinical trials
• Provide researchers, outreach workers, and community educators with effective strategies for outreach, recruiting, and retaining participants from minority populations
• Demonstrate best practices for utilizing electronic resources to identify applicable policies governing clinical trials and human subjects and for identifying funding sources and mechanisms.

Symposium events included a plenary session, panel discussion, three concurrent breakout sessions, three presentations, and concurrent session reports.

The symposium commenced with opening remarks by Dr. Milton Hernandez, Director of OSPRT, and a welcome statement by Dr. Anthony S. Fauci, Director of NIAID. The keynote speaker for the symposium was Dr. Neil Powe, a professor at the Johns Hopkins Medical Institutions and director of the Welch Center for Prevention, Epidemiology, and Clinical Research in Baltimore, Maryland. Dr. Milton Hernandez provided closing remarks.

Results from the overall evaluation forms and the anecdotal comments indicate that NIAID clearly reached its objectives for the symposium and that the symposium was well received by the attending professionals. Nearly all the participants (92 percent) either agreed or strongly agreed that the symposium increased their knowledge and understanding of culturally appropriate methodologies in the outreach, recruitment, and retention of racial and ethnic minority participants in clinical trials.

Two survey instruments were developed to collect data about the symposium and the concurrent breakout sessions. For the overall symposium, the instrument consisted of 10 close-ended and 4 open-ended questions. The survey for the concurrent breakout sessions consisted of five close-ended questions and two open-ended questions. Both surveys provided space for additional comments. Question 4 of the concurrent session instrument, although close ended, also allowed space for comments. Statistics used in the symposium are descriptive, and anecdotal comments extracted from the surveys are listed in their respective sections. See the Appendices section of this report for copies of the evaluation instruments.

A panel discussion following the opening remarks consisted of a moderator and four presenters:

• Moderator: Jane Delgado, Ph.D., M.S., President and Chief Executive Officer, National Alliance for Hispanic Health, Washington, D.C.
• Victoria A. Cargill, M.D., MSCE, Director of Minority Research and Director of Clinical Studies, Office of AIDS Research, NIH, Bethesda, Maryland
• Jacquelyn Fleckenstein, M.D., Associate Professor of Medicine, University of Tennessee, Memphis, Tennessee
• Donna Mildvan, M.D., Chief, Division of Infectious Diseases, and Principal Investigator, AIDS Clinical Trials Unit, Beth Israel Medical Center, New York, New York
• Herman E. Mitchell, Ph.D., Senior Research Scientist, Rho Federal Systems Division, Inc., Chapel Hill, North Carolina

Three concurrent breakout sessions were held at the end of the morning session, as follows:

Session 1: After the Clinical Trial? Then What?

Moderator: Paula Strickland, Ph.D., Acting Director, Office of International Extramural Activities, Division of Extramural Activities, NIAID, NIH, Bethesda, Maryland

Discussion Leaders:

• Marian C. Limacher, M.D., Professor of Medicine, University of Florida College of Medicine, Gainesville, Florida
• Deneen Robinson, B.S.W., HIV Treatment Consultant, Dallas, Texas

Session 2: Minority Investigators in Clinical Trials? How Important Are They?

Moderator: Jenise Gillespie, Ph.D., R.N., Nurse Consultant, Office of the Director, Division of Microbiology and Infectious Diseases, NIAID, NIH, Bethesda, Maryland

Discussion Leaders:

• Clemente Diaz, M.D., Professor and Chairman, Department of Pediatrics, University of Puerto Rico, San Juan, Puerto Rico
• Michele K. Evans, M.D., Deputy Scientific Director, Intramural Research Program, National Institute on Aging, NIH, Baltimore, Maryland

Session 3: Role of the Community Advisory Board and Outreach Activities

Moderators:

• Diane Adger-Johnson, Minority Health and Research Training Analyst, OSPRT, Division of Extramural Activities, NIAID, NIH, Bethesda, Maryland
• Joyce Hunter Woodford, M.P.P., Minority Health and Training Program Officer, OSPRT, Division of Extramural Activities, NIAID, NIH, Bethesda, Maryland

Discussion Leaders:

• Anne Madey, B.S., R.N., Research Nurse Coordinator, University of Tennessee Health Science Center, Memphis, Tennessee
• Matthew Murguia, Director, Office of Program Operations and Scientific Information, Division of AIDS, NIAID, NIH, Bethesda, Maryland

Three individual presentations were delivered during the afternoon session, as follows:

Clinical Trials Resources

Wilma Templin-Branner, M.S., Medical Education and Outreach Group, Oak Ridge Institute for Science and Education, Oak Ridge, Tennessee

Why Primary Care Physicians Don't Refer Their Patients

John Hogan, M.D., Medical Officer, Unity Health Care, Inc., Washington, D.C.

Recruitment and Retention: What Works and Why?

• Kathleen B. Drennan, Chief, Global Marketing and Strategic Business Development, Iris Global Clinical Trials Solutions, Chicago, Illinois
• Donald P. Orr, M.D., Professor of Pediatrics, Nursing Research, and Dietetics and Nutrition, and Director of Adolescent Medicine, Indiana University School of Medicine, Indianapolis, Indiana

Following the individual presentations, the discussion leaders summarized the breakout session discussions.

Symposium Surveys

A survey was administered at the close of each breakout session and at the conclusion of the symposium for the purpose of evaluating the following:

• Overall effectiveness of the initial clinical trials symposium
• Effectiveness of the individual breakout sessions
• Effectiveness of the speakers and of the information and materials disseminated during the symposium and concurrent sessions
• Gathering suggestions and comments about what is desired and needed to diversify clinical trial participation
• Obtaining information that would be useful and/or would enhance future clinical trial symposia

Additional Information

For more information on the symposium outcomes, please contact

Diane Adger-Johnson
Minority Health and Research Training Analyst
Office of Special Populations and Research Training
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases, NIH, DHHS
6700-B Rockledge Drive, Room 2261
Bethesda, Maryland 20892-7610
Office: (301) 402-8969
Fax: (301) 496-8729
da15a@nih.gov