Blog – Wilmar Igl, PhD

Comments on the 3-year work plan
for the Methodology Working Party (MWP) of the EMA

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…

2023-11-27wiliglUncategorized

Macro “ExtractComments” –
Export comments from MS Word to MS Excel

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…

2023-08-11wiliglUncategorized

Hype, not hope – A comment on Ruberg et al. (2023) “Application of Bayesian approaches in drug development: starting a virtuous cycle”

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…

2023-05-17wiliglUncategorized

Federated Analysis with R/DataSHIELD –
Installation, Data Import, Data Analysis [Tutorial]

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…

2023-02-07wiliglUncategorized

Handling multiple windows with a searchable Window Switcher
(MS Windows, Linux, Browsers )

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…

2022-10-01wiliglUncategorized

The Dandelion Hub – A (technical) review of an open-source web app (R/Shiny, MariaDB) to support global civil-rights movements

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?…

2021-11-20wiliglUncategorized

SAS University Edition – free for non-commercial use (hear, hear)

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…

2019-06-11wiliglUncategorized

AV in an AI world: How to make tele-conferences more effective

In this blog, I would like to argue that current standards of tele-conferences can and should be further improved and tele-conferences may help to reduce job-related travels and carbon emissions. I used the title “AV in an AI world” because I am still surprised to see how low the quality of tele-conferences (AV=audiovisuals) in many…

2018-10-14wiliglUncategorized

Tech suffers from lack of humanities, says Mozilla head

Considering myself an academic with a social science (MSc, PhD in psychology) and tech (MSc Medical Statistics, Post-doc in genomics) background, I find it highly interesting that Mitchell Baker, head of the Mozilla Foundation (cf Firefox browser), is arguing that hiring employees who mainly come from STEM (Science, technology, engineering and maths) will produce a…

2018-10-14wiliglpolitics

Doug Altman: A good one gone …

Doug Altman, a professor of statistics at the University of Oxford, died June 3, 2018. Some of his achievements from the Orbituary in The Scientist [1] and Cochrane Library [2]: 1986: Publication of Bland-Altman plot, an incredibly popular technique to visually compare two different methods of taking clinical measurements. According to Nature in 2014, their…

2018-07-04wiliglUncategorized