In randomized-controlled trials, interim analyses are often planned for possible early termination of the trial for claiming superiority or futility of a new therapy. Formal interim analyses are performed, closely following the specifications in the study protocol to maintain the overall type I error rate at a nominal level. While unblinding is necessary to conduct the formal interim analysis in blinded studies, data before unblinding also have information, to some extent, about the potential treatment difference between the groups. This tool can be used for investigators to determine appropriate timings of conducting the unblinded interim analyses. With this tool, investigators may skip some of the planned interim analyses when the interim result at that time point unlikely supports early termination of the trial for superiority or futility of the new treatment.
|Maintainer||Kyongsun Pak <[email protected]>|
|License||GPL (>= 2)|
|Package repository||View on GitHub|
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