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.