The challenge of minority recruitment in clinical trials for AIDS

Abstract

The underrepresentation of minorities among participants in\nHIV-related drug trials is of serious concern, and of ethical, social, and\nscientific importance. Clinical trials are the initial arena in which\npromising compounds are studied. As a direct consequence of the results of\nthese trials, recommendations on their use in a wider population are\ndeveloped. The absence of a segment of the population with specific ethnic\ncharacteristics from initial trials may prevent scientists from detecting\nimportant differences in the response to these agents and particular side\neffects. Factors like concomitant medications, associated medical conditions,\nor illicit drug intake may determine the response or the lack of response to\nthe specific agent. Indeed, in any study that attempts to address differences\nin response in minority populations, these populations must be oversampled in\nrelation to their proportion in the population in order to have sufficient\nstatistical power to detect such differences. An opportunity to receive a\npotentially lifesaving or clinically beneficial treatment should be available\nto all who need it. The compelling scientific, ethical, and social reasons for\ninclusion of minorities in clinical trials justify the necessary efforts to\naccomplish this goal.