FLEX-CP-DT: A Flexible Conditional Power Framework for Interim Futility Analysis in Clinical Trials with Count Endpoints and Temporal Trends
FLEX-CP-DT:计数终点与时间趋势下的期中无效性分析
Many large-scale phase III trials with recurrent event endpoints include a pre-planned interim analysis to evaluate early futility. Conditional power (CP), which quantifies the probability of achieving statistical significance at the final analysis given the interim data, is a commonly used tool to support such decisions. The standard negative binomial model with an offset term, widely adopted for analyzing recurrent events, implicitly assumes that event rates and treatment…