MINI-SYMPOSIUM 1: Beyond Conventional RCTs: Exploring Design Options and Modelling in Drug Development | Part I
Tracks
PARALLEL HALL 1 (Maurice Saltiel I & II Hall)
| Thursday, July 25, 2024 |
| 9:00 AM - 10:30 AM |
| PARALLEL HALL 1 (Maurice Saltiel I & II Hall) |
Overview
Organisers: Marcia Rueckbeil (Amsterdam NL), Els Goetghebeur (Ghent BE), Mouna Akacha (Basel CH) | Ιn collaboration with the ISCB Statistics in Regulatory Affairs (SiRA) Subcommittee
Details
This session will explore the changing landscape of study design options and modeling techniques in the field of drug development. While randomized controlled trials (RCTs) are considered the gold standard for establishing causal relationships and estimating treatment effects, alternative approaches have gained traction in recent years. This shift is also evident in the guidance provided by regulatory agencies such as the FDA and EMA, who have issued recommendations for externally controlled trials, single-arm trials and model-informed drug development.
With invited speakers representing academia, industry, and regulatory bodies, this session aims to foster a dynamic discussion on the opportunities and challenges encountered in adopting novel study designs and modelling approaches in drug development.
Presentations
Prof. Dr. Saskia le Cessie
Leiden UMC, Netherlands
Dr. Marc Vandemeulebroecke
UCB Farchim SA, Basel, Switzerland
Prof. Sarah Zohar
HeKA, Inria
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MINI-SYMPOSIUM 1 | Coffee break
10:30 AM - 11:00 AM
Prof. Dr. Kit Roes
Professor Of Biostatistics
Radboud University Medical Center, Faculty of Medical Sciences, Dept of Health Evidence
Prof. Martin Posch
Vienna Medical University, Center for Medical Data Science, Institute of Medical Statistics, Austria
Panel Discussion
All Speakers & Organisers & Marina Savelieva (Novartis Pharma AG)
Chair
Tim Friede
University Medical Center Goettingen
Marcia Rückbeil
European Medicines Agency
