gms | German Medical Science

Background: There is increasing interest by the industry to use R for data analysis as well as for designing trials. At the moment, no R package is available for performing confirmatory adaptive designs in a comprehensive sense (e.g., design and analysis for continuous, binary, and survival endpoint). Nevertheless, for group sequential tests there is the R package gsDesign, developed by Keaven Anderson (copyright Merck Research Laboratories), which is well established and covers many relevant designs. There are several R packages that address the issue of adaptive designs, most of them with special reference to research results from the authors, but none covers the broad range of applications that is nowadays available.

Methods: In rpact (R Package for Adaptive Clinical Trials) particularly, the methods described in the recent monograph of Wassmer and Brannath [1] are implemented and made available for the public. It includes methods for group sequential and for adaptive confirmatory designs. The validation of the package is done compliant to FDA/GxP guidelines and to the validation process of “Base R” and “Recommended Packages”.

In my talk, I will give an overview of existing R packages for adaptive designs and the current status of rpact. I will describe the background of our development strategy including aspects of our technical environment.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.