Abstract
SUMMARY Trials which randomize intact social groups, or clusters, to different interventions are becoming increasingly widespread. Although statistically less efficient than trials which randomize individuals, such designs are often preferred from a practical or ethical point of view, particularly in the evaluation of health care or educational strategies. We discuss selected issues that arise in the conduct of such trials, including the choice of design, ethical implications, sample size estimation and approaches to the analysis. The discussion is closely tied to methodological issues that have arisen in a recent evaluation trial of a new antenatal care programme, as sponsored by the Special Programme of Research, Development and Research Training in Human Reproduction of the World Health Organization.
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