2023 – 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

Wilmar Igl, PhD

Professional

Yearly Archives: 2023

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

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

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

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

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

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

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

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

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

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

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