Document 0590 DOCN M9590590 TI AIDS clinical trials: why they have recruiting problems. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023. DT 9509 AU Mirkin B SO AIDS Treat News. 1995 Feb 17;(no 217):1-4. Unique Identifier : AIDSLINE AIDS/95700328 AB Enrolling the number of volunteers needed for clinical trials is a significant problem. There are generally two obstacles to enrollment in AIDS trials: the quality of the publicity and outreach efforts, and the design of the trials themselves. Drug companies' efforts at maintaining secrecy for their new treatment drugs are viewed as a roadblock to properly promoting clinical trials. Variances in quality and content of news releases, flyers, and other promotional materials regarding new trials lead to either excellent understanding of the treatment being studied, or to confusion. Food and Drug Administration (FDA) guidelines for advertisements to recruit subjects also dilute promotional effectiveness. Large candidate resources such as women, people of color, and other underserved populations are largely ignored for clinical trials. Reasons include additional costs of caring, transporting, and sheltering many of these people; and unspoken prejudices. Study designs with too many exclusion rules or overly narrow inclusion criteria often disrupt recruiting vigor and sometimes bar the very people the study needs. There is also a tendency for study designs to not fit real-world needs. For example, long-term monotherapy trials become less attractive over time as combination therapy becomes more promising. Finally, there is a belief that potential volunteers are becoming burnt out due to pessimism about what trials can do for them. DE *Acquired Immunodeficiency Syndrome Blacks CD4 Lymphocyte Count *Clinical Trials Ethics, Medical Hispanic Americans Human Women's Health NEWSLETTER ARTICLE SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).