Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations.

Abstract

Site identification, site selection, and study start-up have become the focus of improvement by organizations conducting clinical trials. To examine and measure the process from site identification through site activation, Tufts Center for the Study of Drug Development (CSDD) conducted a comprehensive survey among pharmaceutical organizations, biotech companies, and contract research organizations (CROs). Responses from over 400 unique companies were gathered and analyzed. The results indicate that the start-up process is on average 5 to 6 months in total duration, and cycle times across all activities, including site identification, site selection, and study start-up, are faster for repeat sites than for new sites. Comparisons between sponsor and CROs indicate that CROs completed all site-related activities 6 to 11 weeks faster than sponsors. Other areas impacting cycle times were examined, including centralized versus decentralized functions, investment in technology, and organizational strategies that improve cycle time efficiency and performance. Tufts CSDD will explore this area in future research to gather additional insights into other factors that may be associated with speed and efficiency.