Center for Bioethics

Cluster Randomized Clinical Trials: Ethics and Science

Cluster randomized clinical trials can have an advantage over individual subjects being randomized. It can be a cost-effective method to obtain data. Some of the disadvantages can be the increase in complexity and statistical analysis.

Related Resources

Weijer, C., Grimshaw, J. M., Taljaard, M., Binik, A., Boruch, R., Brehaut, J. C., … Zwarenstein, M. (2011). Ethical issues posed by cluster randomized trials in health research. Trials, 12, 100.

Osrin, D., Azad, K., Fernandez, A., Manandhar, D. S., Mwansambo, C. W., Tripathy, P., & Costello, A. M. (2009). Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Bulletin of the World Health Organization, 87(10), 772–779.

Hutton, J. L. (2001). Are distinctive ethical principles required for cluster randomized controlled trials? Statistics in medicine, 20(3), 473-488.

Edwards, S. J. L., Braunholtz, D. A., Lilford, R. J., & Stevens, A. J. (1999). Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ: British Medical Journal, 318(7195), 1407–1409.