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More-EUROPA
More-EUROPA
While randomized controlled trials (RCTs) remain the mainstay in drug development, approval, and reimbursement, the potential of real-world data (RWD) to contribute to the understanding of drug effects is increasingly realized.
Evidence based on RWD – real world evidence (RWE) – can contribute significantly to the evidence to support decision-making throughout all phases of (clinical) drug development, as well as improve efficiency in the design and conduct of clinical trial programs.

About More-EUROPA

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 (HTA) agencies. The project is funded by the Horizon Europe framework programme, the main EU fund for research and innovation. The project involves 15 public and private organizations from seven EU countries, and started on 1st January 2023 lasting for five years.

Objectives of the project

The main objectives of the More-EUROPA project are to:

  1. To generate a qualitatively generalizable account of patient and stakeholder perspectives on SWOTs of RWD use in regulatory/HTA decision-making.
  2. To explain to patients how data from other sources than clinical trials can be used to generate additional knowledge on medicines and medical devices: a training module on the analysis of data obtained from other sources than clinical trials, their limits, their potential contribution to scientific and medical knowledge.
  3. To assess the representativeness of the patient population in registries.
  4. To explore patient-relevant information and the current practices regarding PROs and patient-reported outcome measures (PROMs) of the case studies in More-EUROPA.
  5. To share More-EUROPA’s developments and findings with medical coordinators of ERNs and European Patient Advisory Groups, in the context of patient and disease registries created by ERNs.
  6. To develop a framework for the “Ethics of RWD decision-making”.

The main aim of More-EUROPA

The aim of the project is to develop, implement and establish evidentiary standards and methods to address the data and evidentiary needs of regulatory authorities and HTA bodies towards a more efficient use of RWD for the development, registration and assessment of medicinal products in Europe.
The key aims of More-EUROPA are revealed in its work packages (WPs):

  • WP1: Development of novel analytical tools (evidentiary standards)
  • WP2: Establishing RWD accessibility and usefulness (case studies)
  • WP3: Identifying and screening suitable registry-based RWD (screening tool)
  • WP4: Ethical perspectives and patient empowerment for RWD use (ethical and patient perspective)
  • WP5: Dissemination: Guideline development, training and implementation (adoption and use)
  • WP6: Project Management, ensuring a smooth functioning and successful execution of the project.