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Session 2: Platform Trials in Europe: EU PEARL Project and the ACT EU Vision
Session Chair(s)
Daniel Millar, MBA
Senior Director, Strategic Business Transformation
Johnson & Johnson, United States
The European Union-Patient-cEntric clinicAl tRial pLatform (EU-PEARL) initiative has developed new methodologies and tools to expand the master protocol approach into Integrated Research Platforms (IRPs) in collaboration with patient representatives and through consultation with FDA and EMA stakeholders. This session will highlight the deliverables now available to the clinical trial community, the path forward for IRPs in Europe, and the connection to the broader Accelerating Clinical Trials (ACT) EU vision.
Speaker(s)
Integrated Research Platform concept and key deliverables from EU PEARL
Cecile Spiertz, MSC
Netherlands
IRP for Major Depressive Disorder
Stefan Gold
Charité Universitätsmedizin Berlin, Germany
Professor
IRP for Major Depressive Disorder
Fanni-Laura Mantyla
Patient Community Representative, Switzerland
Study Design and Statistical Methods for platform trials, including Regulatory guidance
Franz Koenig, MSC
Medical University of Vienna, Austria
Associate Professor
Study Design and Statistical Methods for platform trials, including Regulatory guidance
Benjamin Hofner, PHD
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Head of Data Science and Methods
Regulatory Perspective on IRPs: Experience with EU CTR to support Complex Clinical Trials.
Olga Kholmanskikh Van Criekingen, MD, PHD
Federal Agency for Medicines and Health Products, Belgium
Clinical assessor