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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)
Cecile Spiertz, MSC
, Netherlands
Integrated Research Platform concept and key deliverables from EU PEARL
Stefan Gold
Professor, Charité Universitätsmedizin Berlin, Germany
IRP for Major Depressive Disorder
Fanni-Laura Mantyla
, Patient Community Representative, Switzerland
IRP for Major Depressive Disorder
Franz Koenig, MSC
Associate Professor, Medical University of Vienna, Austria
Study Design and Statistical Methods for platform trials, including Regulatory guidance
Benjamin Hofner, PHD
Head of Data Science and Methods, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Study Design and Statistical Methods for platform trials, including Regulatory guidance
Olga Kholmanskikh Van Criekingen, MD, PHD
Clinical assessor, Federal Agency for Medicines and Health Products, Belgium
Regulatory Perspective on IRPs: Experience with EU CTR to support Complex Clinical Trials.