Poorly performing sites have long been a challenge for the industry. Research indicates that half of investigative sites under-enroll with 11% of sites in a multi-center study failing to recruit a single patient. Over 80% of clinical trials fail to meet their original timelines, with poor site selection increasing cost of trials by 20% or more. The downstream cost ramifications are significant with a typical Phase III study incurring $2.25 million in expenses for non-active and under-enrolling sites.
Sponsors are under increasing pressure to choose the 'right' sites at the same time that competition is intensifying and recruitment rates are falling. The current practice of adding more sites per study and requiring each sight to recruit fewer subjects per site is a questionable risk mitigation approach.