futility: Interim Analysis of Operational Futility in Randomized Trials with Time-to-Event Endpoints and Fixed Follow-Up

Randomized clinical trials commonly follow participants for a time-to-event efficacy endpoint for a fixed period of time. Consequently, at the time when the last enrolled participant completes their follow-up, the number of observed endpoints is a random variable. Assuming data collected through an interim timepoint, simulation-based estimation and inferential procedures in the standard right-censored failure time analysis framework are conducted for the distribution of the number of endpoints–in total as well as by treatment arm–at the end of the follow-up period. The future (i.e., yet unobserved) enrollment, endpoint, and dropout times are generated according to mechanisms specified in the simTrial() function in the 'seqDesign' package. A Bayesian model for the endpoint rate is used for generating future data (see the vignette for details).

Version: 0.1
Imports: graphics, stats, utils
Suggests: knitr, rmarkdown
Published: 2017-07-28
Author: Yingying Zhuang and Michal Juraska, with contributions from Doug Grove, Peter B. Gilbert, and Alexander R. Luedtke
Maintainer: Michal Juraska <mjuraska at fredhutch.org>
License: GPL-2
NeedsCompilation: no
CRAN checks: futility results

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Reference manual: futility.pdf
Vignettes: Bayesian Model for Incidence Rate
Package source: futility_0.1.tar.gz
Windows binaries: r-devel: futility_0.1.zip, r-release: futility_0.1.zip, r-oldrel: futility_0.1.zip
OS X El Capitan binaries: r-release: futility_0.1.tgz
OS X Mavericks binaries: r-oldrel: futility_0.1.tgz

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