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 email@example.com, 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 40||Welcome||Mette Bliddal, University of Southern Denmark and OPEN, DSFE chair|
|12h 40 to 13h 30||Academic 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 40||Break|
|13h 40 to 14h 05||General assembly (only for members of Danish Society for Pharmacoepidemiology)|
|14h 05 to 14h 50||Regulatory 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 00||Short break|
|15h 00 to 15h 45||Industry perspective on pragmatic trials: The changing face of clinical trials – pragmatic trials from an industry perspective||Simon Skibsted, Senior Director and Head of Real World Data Science & Innovation, Novo Nordisk Inc|
|15h 40 to 16h 00||Closing remarks||Mette Bliddal, University of Southern Denmark, DSFE chair|