Recruit and enroll patients for a prospective medical device designed to obesity. The sponsor (a previous ThreeWire customer) had to complete enrollment in less than six months to meet the enrollment goal of randomized 230 patients across only 10 sites, with a protocol containing very restrictive I/E criteria.
ThreeWire implemented a custom recruitment program including patient outreach using print and broadcast media, a study website and site materials kits along with Patient Interaction Center® (PIC) screening and referral of pre-qualified candidates to participating sites. The program was designed and executed to generate the appropriate number of referrals to each site to avoid exceeding site capacity, and accounting for the learning curve for processing media referrals, as well.
1,177 patients were pre-screened, with 267 referred to sites, resulting in 12 enrolled patients. Based on the success, the sponsor decided to bring the program execution in-house with stated intention to save cost. ThreeWire referrals generated an additional 9 enrollments after the program was transitioned, resulting in a total of 21 enrolled patients.