Methodology for developing a multi-center clinical research study

Multi-center research designs enhance patient recruitment, facilitate timely completion of the study and increase the generalizability of the study results. To establish a multi-center research project meticulous attention should be given to the study design, data quality, and coordination of participating centers. This paper outlines the background, and details the steps that we took to develop a multi-center research study utilizing Botulinum Toxin-A in the treatment of ambulatory children with cerebral palsy.