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Keaven M. Anderson

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Delayed effect asymptotic approximations and simulation

Overview
Computing preliminaries
Design assumptions
Fixed design
Simulation of fixed design
Group sequential design
Same design with weighted logrank
Accumulation of events and average treatment effect over time
Alternate analysis timing and \(\alpha\)-spending strategies
Simulation to verify operating characteristics
Simulate a single trial and perform…

Smoothing hazard rates and survival curves with bshazard

National Aquarium Denmark, Den Blå Planet. Photo by Sandro Katalina. Introduction The R package bshazard (Rebora, Salim, and Reilly 2014) has been available on CRAN since 2014. It might be useful where there is interest in where smoothed hazard rates cross. When there is excess in one arm early and excess in the other arm late, the time at which (smoothed) hazard rates cross can come well before…

gsDesign2 1.1.1, new preprint, and practice award

We are excited to announce the release of gsDesign2 1.1.1. This is a maintenance update that brings both new features and improvements. Built upon the gsDesign experience, gsDesign2 is an R package designed for group sequential clinical trial design under non-proportional hazards.
You can install gsDesign2 from CRAN with:
install.packages("gsDesign2") What’s new in gsDesign2 1.1.1…

simtrial is on CRAN

We are excited to announce the first release of simtrial on CRAN. simtrial is a fast and extensible clinical trial simulation framework for time-to-event endpoints.
You can install simtrial from CRAN with:
install.packages("simtrial") A clinical trial simulation framework simtrial is intended to be a general purpose tool for simulating fixed, group sequential, or adaptive clinical trials.…

gsDesign 3.6.0

We are thrilled to announce the release of gsDesign 3.6.0. gsDesign makes it easy to create group sequential clinical trial designs in R. gsDesign also offers a web interface to enable both design creation/updates without coding and code generation to reproduce the design.
You can install gsDesign from CRAN with:
install.packages("gsDesign") What’s new in gsDesign 3.6.0 Time-to-event…

Books

Clinical trial design Group Sequential Design in R: A Practical Guide to the gsDesign Web Interface
Learn how to use a web interface to design, explore, and optimize group sequential clinical trials leveraging the flexible capabilities of the R package gsDesign.
Springer, Use R! series, forthcoming 2026. Preprint version
gsDesign Technical Manual
Design and analyze group sequential…

Publications

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Selected talks

2025 Conditional Power: The Good, The Bad (and The Ugly?) - Applications to Interim Analyses and Adaptation in Clinical Trials Joint Statistical Meetings, Nashville, TN. Design and simulation software for clinical trials NESS 2025: The 38th New England Statistics Symposium, New Haven, CT. 2024 Design Software for Pivotal Trials Joint Statistical Meetings, Portland, OR. The 7th International…

Software

gsDesign: group sequential design
CRAN | GitHub | Documentation
Video - gsDesign: 15 Years of Development in 5 Minutes
gsDesign Explorer: group sequential design web interface
rinpharma mirror | gsdesign mirror | Documentation
Video - The gsDesign Shiny app for clinical trial design (R/Pharma 2021)
gsDesign2: group sequential design under non-proportional hazards
CRAN |…