Current issues surrounding women and minorities in drug trials

Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last dec...

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Bibliographic Details
Published in:	The Annals of pharmacotherapy Vol. 27; no. 7-8; p. 904
Main Authors:	Wermeling, D P, Selwitz, A S
Format:	Journal Article
Language:	English
Published:	United States 01-07-1993
Subjects:	Clinical Trials as Topic - standards Drug Approval Ethics Committees, Research Ethics, Professional Federal Government Female Government Regulation Human Experimentation Humans Minority Groups Multicenter Studies as Topic National Institutes of Health (U.S.) Patient Selection Research - legislation & jurisprudence Research Subjects Risk Assessment United States United States Dept. of Health and Human Services United States Food and Drug Administration Women United States National Institutes of Health Biomedical and Behavioral Research
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Summary:	Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last decade certain segments of society, particularly women and minorities, have demanded greater participation in clinical drug trials and earlier access to investigational drug therapies. Regulations that have served the clinical research community (pharmaceutical industry, investigators, institutional review boards) as guidelines for safe conduct of human clinical trials are being challenged by social and political change. This article provides an overview of some of the controversy relative to federal regulations governing clinical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research. Literature for this paper was retrieved from a variety of sources including the nonmedical press, editorials, peer-reviewed journals, Department of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration. Scientists evaluating new therapeutic agents ask specific research questions to assess safety, efficacy, and the mechanism(s) of action. Because of concerns for scientific validity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ultimate users of a new drug. Federal regulations and ethical principles allow certain groups of people to be excluded from early research proposals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, and other populations are demanding greater access to investigational drugs. The focus has changed from protection from research risks and burdens to the potential benefits a person or class of people may obtain by participating in a study. Scientists, the pharmaceutical industry, regulators, and society must agree on a safe and efficient mechanism for new drug development that permits more equitable participation of subjects in the various phases of research.
ISSN:	1060-0280
DOI:	10.1177/106002809302700719