title: AIDS--challenges to basic and clinical biomedical research.
abstract: The epidemic of acquired immune deficiency syndrome (AIDS) presents unusual challenges to basic and clinical biomedical research. The issues of clinical trials and access to therapeutic drugs pose dilemmas for researchers, physicians, and AIDS patients and their families. Clinical trials are conducted for two related but separate purposes: definitive identification of which experimental drugs work and which do not (in scientifically controlled trials performed by clinical researchers); and to provide data as to whether drugs are safe and effective so that they can be licensed and made available (determined by the Federal Drug Administration). The public must be made aware of the distinction between the two processes and of the need for strict control of the procedures in each. The National Institute of Allergy and Infectious Diseases, recognizing the need for greater access to clinical trials of investigational drugs by a broader spectrum of the infected population, is establishing the Community Programs for Clinical Research on AIDS. This national program will involve greater participation by community physicians and patients in the design and implementation of AIDS-related research projects. Further, the institute is committed to addressing the implications of the disproportionate representation of blacks and Hispanics among people with AIDS. More minority patients, researchers, and physicians must be brought into the clinical trials of AIDS therapies.
authors.affiliation: National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20894.
authors.forename: A S
authors.initials: AS
authors.lastname: Fauci
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000208:ethnology; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation; D006801:Humans; D007880:Legislation, Drug; D008913:Minority Groups; D018579:Patient Selection; D012106:Research; D012107:Research Design; D035842:Research Subjects; D012586:Science; D014481:United States; D014486:United States Food and Drug Administration