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 th e work of research is devoted to the identification of strategies which ens ure a successful recruitment of patients. Every researcher has learned from experience the many methods needed to enhance patient enrollment into tria ls. Superiority trials in SLE have not been frequent in previous years. Thi s paper describes the challenges encountered with the multicentre SMILE tri al in progress across Canada. We identify areas where patient recruitment i s a problem, potential reasons for the problem, and the results of tactics used to increase enrollment.