Adaptive trial designs with blinded selection of composite endpoints and sample size reassessment

This repository contains the R package and main code to reproduce the results in ``Adaptive clinical trial designs with blinded selection of binary composite endpoints and sample size reassessment'' [Paper] [Preprint] by M. Bofill Roig, G. Gómez, M. Posch and F. Koenig.

In this work, we consider two-arm randomized controlled trials with a primary composite binary endpoint and an endpoint that consists only of the clinically most important component of the composite endpoint. We propose a trial design that allows an adaptive modification of the primary endpoint based on blinded information obtained at an interim analysis.

R-package eselect

The R package is available on CRAN and GitHub. You can install the R package from GitHub using the following code:

# install.packages("devtools")
library(devtools)
install_github("MartaBofillRoig/eselect")

The R package contains the following functions:

eselect: Endpoint selection and sample size reassessment for composite endpoints based on blinded data
eselect_ub: Endpoint selection and sample size reassessment for composite endpoints based on unblinded data
eselectsim: Simulation trials with endpoint selection and sample size reassessment for composite endpoints based on blinded data
eselectsim_ub: Simulation trials with endpoint selection and sample size reassessment for composite endpoints based on unblinded data

Reproducible research

This repository also contains the source files of the paper. Specifically,

In the folder CODE_paper/example, there is the source code for reproduce the illustration;
In the folder CODE_paper/simulations, there is the code to reproduce the simulation study in the paper.