Paris NASH Meeting 2022 has distinguished EU-PEARL’s poster presentation “Boosting drug development in NASH through integrated research platforms: proposal of a master protocol for a NASH platform trial” with the Best Poster Presentation Award. Paris NASH is an important international scientific conference which brings together key opinion leaders in the field of NASH (Nonalcoholic steatohepatitis).
The poster authors are: Juan M. Pericàs, Nicholas DiProspero, Mette SKALSHØJ-KJÆR, Quentin M. Anstee, Peter Mesenbrink, Elena Sena, Jesús Rivera-Esteban, Ramiro Manzano, Franz Koenig, Raluca Pais, Joan Genescà, Frank Tacke, Vlad Ratziu.
Co-designing master protocol templates with patients and regulators
A specific work stream in EU-PEARL is developing this reusable master protocol template to design and execute multi-drug platform trials in non-alcoholic steatohepatitis (NASH), focused on early clinical development. This is set to address critical existing challenges: selection of the optimal trial phase and trial endpoints, use of biomarkers and biopsies and statistical and regulatory considerations.
To this end, the project has engaged with patient representatives and regulators to discuss critical characteristics of a reusable master protocol template for platform trials in NASH. Furthermore, EU-PEARL is creating a clinical site network around NASH, collaborating with the LITMUS project and identifying international recruiting sites for establishing a NASH Integrated Research Platform.
Besides developing a generic framework and a set of tools to conduct collaborative platform trials in any disease area, EU-PEARL is also designing master protocols templates for 4 specific diseases: NASH, Depression, Tuberculosis and Neurofibromatosis.
Access poster here.