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.
General surgery resident exposure to open vascular surgery has significantly decreased. Current and future graduates may not have adequate exposure to open vascular operations to be safely credentialed to perform these procedures in future practice without advanced vascular surgical training.
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