A Regulatory R Packages Infrastructure (RRPI):
Supporting a Wider Use of R in the Pharma Industry

“Every business is a software business.” [1] Watts S. Humphrey, the “father of software quality” Background Corresponding to major changes in many other industries, also the pharmaceutical industry is going through a transformation in its business model from using proprietary software towards open-source software. The proprietary software model is based on external vendors delivering generic…

Approaches to reduce the estimated sample size in clinical trials – A checklist

The following approaches can be considered to reduce the estimated sample size in clinical trials: Objective Choose another objective, e.g. Reduce objectives of study, e.g. phase 2 instead of phase 3, fewer primary/key secondary endpoints, descriptive instead of inferential Change target concept, e.g. physical instead of psychological QOL Operating characteristics: Relax type 1 error Relax…