Ethical considerations in the design of pediatric clinical trials in low- and middle-income countries

Abstract

The global redistribution of clinical trials from high-income to low- and middle-income countries raises concern that populations of less developed countries may be exploited to provide data for marketing approval in developed countries. On the one hand, children lacking adequate healthcare may be exploited through offer of an unfair level of benefits in a clinical trial. On the other hand, a broader understanding of the principle of equipoise may allow for the incorporation of limited healthcare resources into the ethical justification of a clinical trial. In this context, two contrasting case studies involving the use of a placebo control are presented. These cases illustrate that uncertainty is not a sufficient justification for conducting a clinical trial where available treatments are constrained by socioeconomic factors. Rather, concerns about the fairness of a clinical trial based on distributive justice may require modifications to the trial, or motivate change to eliminate socioeconomic disparities.