CURRENT ISSUES SURROUNDING WOMEN AND MINORITIES IN DRUG TRIALS

OBJECTIVE: Our principal objective is to make readers aware of conflic ting demands placed on investigators and the pharmaceutical industry r egarding inclusion of women and minorities in clinical research. Treme ndous pressures have been placed to expedite the drug approval process . Moreover, during the last decade certain segments of society, partic ularly women and minorities, have demanded greater participation in cl inical drug trials and earlier access to investigational drug therapie s. Regulations that have served the clinical research community (pharm aceutical industry, investigators, institutional review boards) as gui delines 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 clin ical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research. DATA SOURCE S: Literature for this paper was retrieved from a variety of sources i ncluding the nonmedical press, editorials, peer-reviewed journals, Dep artment of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration. DATA SYNTHESIS: Scientists evaluating new therape utic agents ask specific research questions to assess safety, efficacy , and the mechanism(s) of action. Because of concerns for scientific v alidity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ulti mate users of a new drug. Federal regulations and ethical principles a llow certain groups of people to be excluded from early research propo sals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, a nd other populations are demanding greater access to investigational d rugs. The focus has changed from protection from research risks and bu rdens to the potential benefits a person or class of people may obtain by participating in a study. CONCLUSIONS: Scientists, the pharmaceuti cal industry, regulators, and society must agree on a safe and efficie nt mechanism for new drug development that permits more equitable part icipation of subjects in the various phases of research.