Enrollment success…This is what we all strive for but unfortunately it does not always happen and there is no money-back guarantee. In 2000, interviews among clinical operations managers found that 20% of all investigative sites fail to enroll a single patient. Since then, results of a 2012 quantitative study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) provided updated metrics characterizing investigative site enrollment performance: 1 in 10 sites, on average, fail to enroll a single patient in a given clinical trial. 1 At an average of $20,000 site start-up cost, and 100 sites needed for your study, that is a potential loss of $200,000. But, how do we reduce the chance of selecting a non-enrolling site?

This paper will review strategies for reducing the likelihood of including a non-enrolling site in your next clinical trial by making a data-driven ‘choice’ instead of making selections by ‘chance.’ The highlighted approaches are certainly not all-encompassing, however, there are a few key strategies that can mitigate your risk of selecting a non-enrolling site. This case study was prepared in collaboration with Janssen and reviews metastatic castrate-resistant prostate cancer in order to outline these research strategies.