Issues of Special Populations in Drug Development

Abstract

Following registration approval, most drugs are used by people representing a wide spectrum of ages, races, and ethnic groups, as well as both sexes. Yet historically, most clinical studies have been almost exclusively conducted in adults (mostly white males) aged 18–65 years. To discuss the issues of special populations in drug development, experts from the pharmaceutical industry, government, and academia convened at a recent workshop. There they spoke frankly about the challenges and opportunities in this important but controversial area of drug development.