Annual meeting 2021 on 26/10

Pragmatic trials: academic, regulatory, and industry perspective

Whereas the traditional randomized controlled trial is designed to establish efficacy of a specific drug, i.e. the effect under ideal conditions, the pragmatic trial is designed to establish effectiveness, i.e. how well the drug works in everyday clinical practice. The topic will be addressed by speakers from regulatory agencies, academia, and the industry.

The meeting take place online 26/10/2021, 12.30-16.00. Please sign up by sending an email to, no later than October 20th. We hope as many of you as possible are able to participate and we are looking forward to see you!

You can find the programme and description of the presenters in this pdf .


12h 30 to 12h 40WelcomeMette Bliddal, University of Southern Denmark and OPEN, DSFE chair
12h 40 to 13h 30Academic perspective on pragmatic trials:
The why and how of pragmatic trials – an academic perspective
Mira G.P. Zuidgeest, Assistant Professor, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
13h 30 to 13h 40Break
13h 40 to 14h 05General assembly (only for members of Danish Society for Pharmacoepidemiology)
14h 05 to 14h 50Regulatory perspective on pragmatic trials
Title: Pragmatic clinical trials in the context of regulation of medicines
Daniel Morales, Wellcome Trust Clinical Research Fellow, Population Health and Genomics, School of Medicine, University of Dundee & Department of Public Health, University of Southern Denmark.
14h 50 to 15h 00Short break
15h 00 to 15h 45Industry perspective on pragmatic trials: The changing face of clinical trials – pragmatic trials from an industry perspectiveSimon Skibsted, Senior Director and Head of Real World Data Science & Innovation, Novo Nordisk Inc
15h 40 to 16h 00Closing remarksMette Bliddal, University of Southern Denmark, DSFE chair

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