Large EU-grant to leverage real world data for patient centered drug licensing and reimbursement decisions

The Radboudumc (Kit Roes, Methodology – Department of Health Evidence) and the UMC Groningen (Peter Mol, overall lead) were granted a large Horizon Europe project to make better use of patient registries to improve drug development and licensing and reimbursement decisions. The project (More-EUROPA) focuses on the more effective and ethical use of registry data to support patient-centered decisions by drug regulators and Health Technology Assessment agencies. The budget for the project is €6.9 million. The grant is awarded from the EU Horizon program, the main EU fund for research and innovation.

The project involves 14 both public and private organizations from seven EU countries, and started on January 1, 2023 and will last five years. The main objectives of the More-EUROPA project are 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 guidelines and decision-making.