About

RPACT® (R Programming for Adaptive Clinical Trials) was founded by Gernot Wassmer and Friedrich Pahlke in May 2017 as a company to offer programming, training, and consultancy in confirmatory adaptive designs using the R software.

The idea is to establish an industry collaboration with the focus on the application of adaptive clinical trials using R.

As our business model, for pharmaceutical companies and CROs, we offer chargeable consultancy services and training in adaptive design methodology, R/Shiny programming, and R package development.

Gernot Wassmer has been an adjunct Professor for Biostatistics at the Institute of Medical Statistics, University of Cologne, Germany. He received his PhD 1993 at the University of Munich, Germany, and was a Research Fellow at the Institute of Statistics, University of Munich, at the Institute for Epidemiology, GSF Neuherberg, and at the Institute of Medical Statistics, University of Cologne, Germany.

His major research interest is in the field of statistical procedures for group sequential and adaptive plans in clinical trials. He has been a member in independent data monitoring committees for international, multi-center trials on different therapeutic fields and also serves as a consultant for the pharmaceutical industry. In 2017, he was a guest professor at the Medical University of Vienna, Austria.

Gernot Wassmer is author of many methodological papers in this area. Thanks to his many years of experience in clinical research, he brings theoretical and statistical know-how to the company. His tasks are as follows:

• Development of the statistical methods of the software
• Methodological advice on the planning, implementation, and analysis of clinical trials
• Planning and implementation of training courses
• Answering methodical customer questions about the software
• Documentation of the statistical methods and theory used
• Implementation of statistical algorithms

Gernot Wassmer's list of publications can be viewed here.

Friedrich Pahlke is an independent consultant for computer and data science, medical statistics and business analytics. He received his PhD 2008 at the University of Lübeck, Germany, and was a Research Fellow at the Institute of Medical Biometry and Statistics, University of Lübeck; major research interest during that time: statistical analysis of genetic data with R.

Friedrich Pahlke has been working full-time as a freelance computer scientist since 2008 and brings information technology know-how to the company through his many years of experience in software development. His tasks are as follows:

• Software requirements analysis
• Software functional specification and design
• Implementation of the software (programming)
• Validation, publication, and maintenance of the software
• User interface design and improvement
• Development of the rpact Shiny app

He has a special research interest in the field of randomization for clinical trials; since 2002 he has implemented, validated and simulated several randomization algorithms in Java and R, incl. covariate and response adaptive randomization methods (e.g. Biased Coin Minimization, Doubly-adaptive Biased Coin Design).

Friedrich Pahlke's list of publications can be viewed here.