Recruitment strategies in superiority trials in SLE: lessons from the study of methotrexate in lupus erythematosus (SMILE).

The task of recruiting patients for a research project can prove to be the most difficult aspect of the entire research process. A large portion of the work of research is devoted to the identification of strategies which ensure a successful recruitment of patients. Every researcher has learned from experience the many methods needed to enhance patient enrollment into trials. Superiority trials in SLE have not been frequent in previous years. This paper describes the challenges encountered with the multicentre SMILE trial in progress across Canada. We identify areas where patient recruitment is a problem, potential reasons for the problem, and the results of tactics used to increase enrollment.