A single center analysis of factors influencing study start-up timeline in clinical trials

Abstract

Aim: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. Materials & methods: The start-up milestones were assessed for 38 studies and analyzed. Results: Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. Conclusion: Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.