The challenge of minority recruitment in clinical trials for AIDS

The underrepresentation of minorities among participants in HIV-related drug trials is of serious concern, and of ethical, social, and scientific importance. Clinical trials are the initial arena in which promising compounds are studied. As a direct consequence of the results of these trials, recommendations on their use in a wider population are developed. The absence of a segment of the population with specific ethnic characteristics from initial trials may prevent scientists from detecting important differences in the response to these agents and particular side effects. Factors like concomitant medications, associated medical conditions, or illicit drug intake may determine the response or the lack of response to the specific agent. Indeed, in any study that attempts to address differences in response in minority populations, these populations must be oversampled in relation to their proportion in the population in order to have sufficient statistical power to detect such differences. An opportunity to receive a potentially lifesaving or clinically beneficial treatment should be available to all who need it. The compelling scientific, ethical, and social reasons for inclusion of minorities in clinical trials justify the necessary efforts to accomplish this goal.