CRAN/E | futility

futility

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

Installation

About

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, offering the option to specify a robust mixture prior distribution, is used for generating future data (see the vignette for details). Inference can be restricted to participants who received treatment according to the protocol and are observed to be at risk for the endpoint at a specified timepoint. Plotting functions are provided for graphical display of results.

github.com/mjuraska/futility
Bug report File report

Key Metrics

Version 0.4
Published 2019-04-11 1448 days ago
Needs compilation? no
License GPL-2
CRAN checks futility results

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Maintainer

Maintainer

Michal Juraska

mjuraska@fredhutch.org

Authors

Yingying Zhuang

aut

Michal Juraska

aut / cre

Doug Grove

ctb

Peter Gilbert

ctb

Alexander Luedtke

ctb

Sanne Roels

ctb

An Vandebosch

ctb

Material

README
Reference manual
Package source

Vignettes

Bayesian Model for Incidence Rate

macOS

r-release

arm64

r-oldrel

arm64

r-release

x86_64

r-oldrel

x86_64

Windows

r-devel

x86_64

r-release

x86_64

r-oldrel

x86_64

Old Sources

futility archive

Imports

graphics
stats
utils

Suggests

knitr
rmarkdown