gsDesign - Group Sequential Design

Derives group sequential clinical trial designs and describes their properties. Particular focus on time-to-event, binary, and continuous outcomes. Largely based on methods described in Jennison, Christopher and Turnbull, Bruce W., 2000, "Group Sequential Methods with Applications to Clinical Trials" ISBN: 0-8493-0316-8.

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biostatisticsboundariesclinical-trialsdesignspending-functions

14.23 score 56 stars 9 dependents 564 scripts 8.0k downloads

gMCPLite - Lightweight Graph Based Multiple Comparison Procedures

A lightweight fork of 'gMCP' with functions for graphical described multiple test procedures introduced in Bretz et al. (2009) <doi:10.1002/sim.3495> and Bretz et al. (2011) <doi:10.1002/bimj.201000239>. Implements a flexible function using 'ggplot2' to create multiplicity graph visualizations. Contains instructions of multiplicity graph and graphical testing for group sequential design, described in Maurer and Bretz (2013) <doi:10.1080/19466315.2013.807748>, with necessary unit testing using 'testthat'.

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7.10 score 14 stars 1 dependents 20 scripts 419 downloads

gsDesignNB - Sample Size and Simulation for Negative Binomial Outcomes

Provides tools for planning and simulating recurrent event trials with overdispersed count endpoints analyzed using negative binomial (or Poisson) rate models. Implements sample size and power calculations for fixed designs with variable accrual, dropout, maximum follow-up, and event gaps, including methods of Zhu and Lakkis (2014) <doi:10.1002/sim.5947> and Friede and Schmidli (2010) <doi:10.3414/ME09-02-0060> as well as extensions for score-test sizing and gaps between events. Supports group sequential monitoring by building on the 'gsDesign' package. Includes recurrent-event simulation utilities (including seasonal rates), interim data truncation, Wald and score-test inference for rate ratios, and blinded or unblinded information estimation and sample size re-estimation.

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6.65 score 1 stars 19 scripts 134 downloads