Tufts CSDD presents the findings of a new study assessing practices and inefficiencies associated with site selection, study startup, and site activation in starting clinical trials.
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.
goBalto Select, a purpose-built study startup (SSU) site selection and feasibility tool can improve site selection capability by combining internal and external data sources so a complete target site profile can be created. Select mitigates risk factors for recruitment and retention by finding the optimum alignment of top-performing sites with substantial patient databases, and quickly assessing which sites have performed best in similar studies. As part of this effort, Select provides information on start-up time, patient retention and quality. It can also facilitate communications and a desire to build a collaborative long lasting partnership, fostering a foundation of trust and commitment.