A cluster randomization trial is one in which intact social units, or clusters of individuals, are randomized to different intervention groups. Trials randomizing clusters have become particularly widespread in the evaluation of non-therapeutic interventions, including lifestyle modification, educational programmes and innovations in the provision of health care. The increasing popularity of this design among health researchers over the past two decades has led to an extensive body of methodology on the subject. This is the first book to present a systematic and united treatment of this topic; it contains distinctive chapters on the history of cluster randomized trials, ethical issues and reporting guidelines.

Allan Donner is Professor and Chair of the Department of Epidemiology and Biostatistics, University of Western Ontario, Canada.

Neil Klar is Senior Biostatician in the Division of Preventive Oncology, Cancer Care Ontario, Canada.