Ethnic minority under-representation in clinical trials. Whose responsibility is it anyway?

Abstract

Ethnic minority people are frequently under-represented in clinical trials. This potentially affects the generalisability/external validity of the trial findings. This not only has important repercussions regarding the safety and the efficacy of new drug use in ethnic minority groups, but also reduces opportunities for subgroup analysis. There can be no scientific basis for excluding this group of people from clinical trials. Aims to provide a mix of theoretical and empirical debates, in order to make sense of ethnic minority exclusion from clinical trials, and suggest possibility of change. Recommends that educational programmes should be directed at clinical trial investigators and funding bodies, to increase their awareness of under-representation of ethnic minority people in clinical trials. Ethics committees could also redress this inequality by providing guidance for investigators, and by being more rigorous about reviewing clinical trial protocols. Provides a set of guidelines to "enlighten" and aid health professionals in working with ethnic, linguistic and culturally diverse populations. The guidelines require additional work and have cost implications. Argues that cost should not be allowed as an acceptable excuse for excluding ethnic minority people from clinical trials.