Abstract

In this paper, we respond to Andrew Avins's recent review of methods whose use he advocates in clinical trials, to make them more ethical. He recommends in particular, “unbalanced randomisation”. However, we argue that, before such a recommendation can be made, it is important to establish why unequal randomisation might offer ethical advantages over equal randomisation, other things being equal. It is important to make a pragmatic distinction between trials of treatments that are already routinely available and trials of restricted treatments. We conclude that unequal randomisation could, indeed, be an ethical compromise between protecting the interests of participants and those of society.