On the inclusion of non-concurrent controls in platform trials with a futility interim analysis

This is an accompanying repository for the paper “On the inclusion of non-concurrent controls in platform trials with a futility interim analysis” by Pavla Krotka, Martin Posch, and Marta Bofill Roig. It contains the code to reproduce all simulations and figures presented in the manuscript and supplementary material.

The repository is structured as follows:

• Folder functions:

  This folder contains all functions necessary to run the simulation study:

  • runtrial_IA_MAE.R - function for running a platform trial with 2 treatment arms and an interim analysis of Arm 1 at the time of adding the Arm 2, where Arm 2 is evaluated using the mean adjusted estimator
  • get_mae.R - function for computing the mean adjusted estimator
  • bootstrap_functions.R - function for performing stratified bootstrap with interim analysis to compute the variance of the mean adjusted estimator
  • sim_function_MAE_par.R - wrapper function for performing simulation studies for a given set of scenarios

• Folder paper_sim:

  • simscript_paper_final.R: This script contains the code to reproduce all simulations included in the paper and supplementary material. The results for the individual scenarios are then saved in the subfolder results_final.
  • figures_paper_final.Rmd: This file contains the code to create all figures presented in the paper and the supplementary material. The figures are saved in the subfolder figures in a .pdf and .tiff formats.

Working directories

The required working directory for each code file is the folder where this file is located, i.e., for running the simulations, the working directory should be set to the folder paper_sim.

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Funding

This publication is supported by the predoctoral program AGAUR-FI ajuts (2024 FI-1 00401) Joan Oró, which is backed by the Secretariat of Universities and Research of the Department of Research and Universities of the Generalitat of Catalonia, as well as the European Social Plus Fund.

This work was supported by Grant PID2023-148033OB-C21 funded by MICIU/AEI/10.13039/501100011033 and by FEDER/UE; and the Departament d’Empresa i Coneixement de la Generalitat de Catalunya (Spain) under Grant 2021 SGR 01421 (GRBIO).

Marta Bofill Roig is a Serra Húnter Fellow.