Introduction This tutorial describes how to install Rstudio Server on a Windows 11 host system by installing it as a Docker image in Ubuntu 22.04 LTS as virtual machine as a guest system using the Windows Subsystem for Linux (WSL2). This way the complete functionality of the Linux operating system will be available for Rstudio…
“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…
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…
The Methodological Working Party (MWP) of the EMA has published a draft 3-year work plan [1] on October 30, 2023, which I have commented below. Content L43-45: The strategic goals of The Methodological Working Party (L43-45) are supported. However, innovation and best-practice efforts should be complemented by efforts to provide a standardized, “same practice” harmonized…
Introduction The development of clinical documentation in drug development requires interdisciplinary communication and collaboration regarding complex, comprehensive text documents over multiple revision cycles resulting in documents of 50 to 200 pages with several hundreds of comments and replies. Reviewing such documents is time-consuming because it is often not clear: To answer these questions, text-related comments…
Wilmar Igl, PhD1 & John Constant, PhD2 1Biostatistics Consulting Services, ICON PLC, Sweden2Scientific Affairs, ICON PLC, Canada “It’s about getting things down to one number.Using the stats the way we read them,we’ll find value in players that no one else can see.”Peter Brand, Moneyball [1] Introduction Ruberg et al.2 have recently published a perspective on…
Introduction Federated Analysis (FA) has received rapidly increasing attention over the last three years in the scientific literature (Figure 1). It describes the centralized analysis of de-centralized databases while preserving the privacy of personal data. FA was proposed for the identification of rare adverse events in international post-marketing studies to overcome legal barriers [1]. This…
1. Background A common user problem is the handling of multiple open documents (windows, buffers, tabs) with long and similar file names, titles and paths, which have similar content. For example, if you have to merge the revisions of multiple authors of the same document. The problem is to find a specific (open) document in…
In the following blog I am taking a critical look a the The Dandelion Hub platform (https://dhub.global), which seems a promising open-source project to support the global civil-right movements, or in the words of the developers “to create a movement of movements for science, people power, and a livable future”. Can’t be wrong, can it?…
A retired friend with extensive SAS experience asked me, what free or open-source programme similar to SAS was available. After I hadn’t used SAS much over the last years, I did some research and actually found out that SAS is offering the SAS University edition [1] for free for non-commercial use (as it seems since…
