Next May 20th is International Clinical Trials Day (ICTD). EU-PEARL will actively participate in the event organised every year by ECRIN, a partner in the Consortium, to foster debate around multinational clinical trials. This edition, ICTD will focus on platform trials, a topic at the heart of EU-PEARL. Indeed, this IMI project is creating a framework of collaborative platform trials, where patients play a bigger part in trial designs and outcomes.
Project leading members Cecile Spiertz (Janssen), Martin Posch (Medical University of Vienna) and Valentina Strammiello (European Patients’ Forum) will take part in a panel discussion (14h-16h CEST) on the statistical, regulatory & ethical challenges related to the trial, its design and implementation. The session will be chaired by EU-PEARL’s scientific coordinator, Joan Genescà (Hospital Universitari Vall d’Hebron), and will count also with the participation of Fergus Sweeney (European Medicines Agency), Frank Hulstaert (Belgian Health Care Knowledge Centre) and Marco Cavaleri (European Medicines Agency).
ICTD congregates each year representatives from academia and clinical research institutions, patient organisations, industry, health authorities and regulatory, ethics and public funding bodies from Europe and beyond. According to the organisers, this ICTD edition “hopes to help answer some of the following questions: What are the underlying objectives of a platform trial? Which parameters must be considered in the design, statistical plan and data management? How should one address regulatory and ethical issues as well as the involvement of patients? What types of management, economic and governance concerns may be encountered when we use this trial model?”
A full day agenda
Barbara Kerstiens (Research & Innovation DG, European Commission) will open the event at 10 am (CEST). Marion Mafham (RECOVERY trial) will offer a keynote on the power of large simple trials. Three other platform trials will be discussed during the morning session with a special focus on design and operational considerations and challenges.
The afternoon will begin with a session on the patient perspective lead by Valentina Strammiello (EPF) and will follow with a keynote by Liz Morrell (University of Oxford) about “The platform trial as a working environment”. The panel discussion is scheduled to start next. A session on the EMA Clinical Trial Information System (CTIS) for platform trials conducted by Noémie Manent (European Medicines Agency) and the intervention of ECRIN’s Director General, Jacques Demotes will close the ICTD.
Register here: ICTD