OptimalGoldstandardDesigns

Methods to calculate optimal design parameters for one- and two-stage three-arm group-sequential gold-standard non-inferiority trial designs with or without binding or nonbinding futility boundaries.

https://github.com/jan-imbi/optimalgoldstandarddesigns

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Methods to calculate optimal design parameters for one- and two-stage three-arm group-sequential gold-standard non-inferiority trial designs with or without binding or nonbinding futility boundaries.

README.Rmd

---
output: github_document
bibliography: paper/bibfile.bib
---



```{r, include = FALSE}
knitr::opts_chunk$set(
  collapse = TRUE,
  comment = "#>",
  fig.path = "man/figures/README-",
  out.width = "100%",
  cache = FALSE
)
```

# OptimalGoldstandardDesigns 


[![doi](https://img.shields.io/badge/doi-10.1002%2Fsim.9630-blue)](https://doi.org/10.1002/sim.9630)
[![Codecov test coverage](https://codecov.io/gh/jan-imbi/OptimalGoldstandardDesigns/branch/master/graph/badge.svg)](https://app.codecov.io/gh/jan-imbi/OptimalGoldstandardDesigns?branch=master)
[![R-CMD-check](https://github.com/jan-imbi/OptimalGoldstandardDesigns/actions/workflows/R-CMD-check.yaml/badge.svg)](https://github.com/jan-imbi/OptimalGoldstandardDesigns/actions/workflows/R-CMD-check.yaml)
[![License](https://img.shields.io/github/license/jan-imbi/OptimalGoldstandardDesigns)](https://github.com/jan-imbi/OptimalGoldstandardDesigns/blob/master/LICENSE.md)


This package contains the code used in the calculations for
our [paper](https://doi.org/10.1002/sim.9630)
on the optimization of the two-stage group sequential three-arm gold-standard
design for non-inferiority trials.

It allows for the simultaneous optimization of the
allocation ratios for both stages (in two-stage designs),
the efficacy boundaries, and the
futility boundaries. The optimization is performed
under type I and II error constraints and the objective function is
customizable by the user.
Methods to optimize two- and one-stage designs are available.

# Installation
You can install the CRAN version of this package by typing the following
command into your R console:
```{r, eval=FALSE}
install.packages("OptimalGoldstandardDesigns")
```

You can install the GitHub Version by typing:
```{r, eval=FALSE}
remotes::install_github("jan-imbi/OptimalGoldstandardDesigns")
```

You can also [clone this repository](https://docs.github.com/en/repositories/creating-and-managing-repositories/cloning-a-repository)
directly from github. This will
give you access to the /data/ subdirectory, which contains code to reproduce
the examples from the paper.

# Documentation
You can check out an online version of the documentation 
[using this link.](https://jan-imbi.github.io/OptimalGoldstandardDesigns/).
In particular, you might be interested in reading the [*Usage guidance* article](https://jan-imbi.github.io/OptimalGoldstandardDesigns/articles/Introduction.html).

# Example
## A one-stage desgin
```{r}
library(OptimalGoldstandardDesigns)
optimize_design_onestage(
  alpha = .025,
  beta = .2,
  alternative_TP = .4,
  alternative_TC = 0,
  Delta = .2,
  print_progress = FALSE
)
```

## A two-stage design
```{r}
optimize_design_twostage(
  beta = 0.2,
  alternative_TP = 0.4,
  alternative_TC = 0,
  Delta = 0.2,
  print_progress = FALSE,
  binding_futility = TRUE
)
```


# References
Meis, J, Pilz, M, Herrmann, C, Bokelmann, B, Rauch, G, Kieser, M. Optimization of the two-stage group
sequential three-arm gold-standard design for non-inferiority trials. *Statistics in Medicine.* 2023; 42(
4): 536 558. [doi:10.1002/sim.9630](https://doi.org/10.1002/sim.9630).

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