Faculty of Pharmacy of Universidade de Lisboa (FFUL) is one of the fourteen winners of the Horizon Europe Health’s Program – More Effectively Using Registries to SuppOrt PAtient-Centered Regulatory and HTA Decision-Making. Led by University Medical Center Groningen, the project has a length of 60 months with a funding of 6.99 million euros.
The project aims to:
“a) expand the knowledge of drug efficacy and safety using ‘Real World Data’ (RWD; data obtained from clinical practice) and to supplement data from clinical trials (so-called RCTs = randomized controlled trials) using specific ‘case’ studies supported by developed new analytical tools and by establishing a protocol for a registry-based RCT;
b) develop a methodological framework including analytical tools to integrate evidence derived from RCTs and (multiple) RWD sources;
c) develop an ethical framework describing practice-based ethical requirements for generating and using patient-relevant RWD to support decision making;
d) create an integrated framework, incorporating methodological tools and ethical considerations, to promote the acceptance and use of evidence based on RWD (=RWE, Real World Evidence) throughout the drug life cycle in drug registration and HTA (=HTA, Health Technology Assessment) guidelines and decision-making.”
At FFUL the project is coordinated by Bruno Sepodes and Carla Torre from Systems Integration Pharmacology, Clinical & Regulatory Science Lab at Research Institute for Medicines (iMed.ULisboa). The project also counts with the participation of Beatriz da Silva Lima and João Rocha, from the same Lab.