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Abstract:
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In this talk we propose Sequential Patient Recruit Monitoring (SPRM), a new and efficient accrual monitoring method. Built on a sequential probability ratio test using Woodroofe boundaries, SPRM is an evidence-based, decision-support tool that provides opportunity for corrective action in a timely manner. Suitable for the modern, centralized data management environment, it requires minimal effort to maintain. The method can easily accommodate protocol changes involving sample size and/or recruitment period modification. We illustrate the method using real accrual data from two phase III, multi-center clinical trials.
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