Plotting N-T Plane for Decision on Performing an Interim
Analysis
Description
In randomized-controlled trials, interim analyses are often planned for possible early
trial termination to claim superiority or futility of a new therapy. Blinded data also have
information about the potential treatment difference between the groups. We developed a blinded
data monitoring tool that enables investigators to predict whether they observe such an unblinded
interim analysis results that supports early termination of the trial. Investigators may skip
some of the planned interim analyses if an early termination is unlikely.
This tool will provide reference information about N: Sample size at interim analysis, and T: Total
number of responders at interim analysis for decision on performing an interim analysis.