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The Role And Challenges Of Cluster Randomised Trials For Global Health, Louis Dron, Monica Taljaard, Yin Bun Cheung, Rebecca Grais, Nathan Ford, Kristian Thorlund, Fyezah Jehan, Etheldreda Nakimuli-Mpungu, Denis Xavier, Zulfiqar Ahmed Bhutta, Jay J H. Park, Edward J. Mills

Department of Paediatrics and Child Health

Evaluating whether an intervention works when trialled in groups of individuals can pose complex challenges for clinical research. Cluster randomised controlled trials involve the random allocation of groups or clusters of individuals to receive an intervention, and they are commonly used in global health research. In this paper, we describe the potential reasons for the increasing popularity of cluster trials in low-income and middle-income countries. We also draw on key areas of global health research for an assessment of common trial planning practices, and we address their methodological shortcomings and pitfalls. Lastly, we discuss alternative approaches for population-level intervention trials …