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

Abstract

Background: Site identification, site selection, and study start-up have become the focus of improvement by organizations conducting clinical trials.

Methods: 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.

Results: 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.

Conclusion: Tufts CSDD will explore this area in future research to gather additional insights into other factors that may be associated with speed and efficiency.

Keywords: cycle time; performance; site identification; site selection; study start-up; technology.