Description
Trial Design in Respiratory Disease Based on the Win Probability.
Description
Provides analysis results and trial simulation functions for the I-SPY Acute Respiratory Disease Syndrome trial based on composite ranked outcomes. The composite ranked outcome is a hierarchical outcome where trial participants are ranked first by 28 day mortality, then ventilator days, then by advanced respiratory support days. A Bayesian win probability approach is used for analysis. Trial design options include group sequential looks for safety, superiority, futility, and adjustment of randomization probabilities.