Sequential Event Rate Monitoring.

ABSTRACT: Effective monitoring of event rates is essential for maintaining statistical power and study integrity in clinical trials, particularly when the primary endpoint involves time-to-event outcomes. We propose Sequential Event Rate Monitoring (SERM), a new and innovative approach for continuous monitoring of event rates. SERM leverages the Sequential Probability Ratio Test (SPRT) with improved boundaries derived from the nonlinear renewal theorem by Kim and Woodroofe (2003). This method represents the first practical implementation of their theoretical work in this area. SERM offers several tangible benefits, including ease of implementation, efficient use of data, and broad applicability to trials. Decision boundaries can be directly obtained from simple formula. A detailed illustration of th

SUBMITTER: Kim DY 

PROVIDER: S-EPMC12828109 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature