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Objectives and ambition More-EUROPA

We word towards a more efficient use of real-world data in the development, registration and assessment of medicinal products in Europa
We word towards a more efficient use of real-world data in the development, registration and assessment of medicinal products in Europa
More-EUROPA has the following specific objectives: 

  1. Expand knowledge on drug efficacy and safety using RWD augmenting RCT data (establish value) using specific case studies in WP2 that are supported by novel analytical tools developed in WP1, and by creating a protocol for a registry-based RCT in WP5;
  2. Develop a methodological framework (establish value) including analytical tools to integrate evidence derived from RCTs and (multiple) RWD sources (WP1);
  3. Develop and standardize methods to increase usability of RWD across different registries (enable use) (WP1, WP2);
  4. Develop a screening tool to timely identify suitable registries and RWD (enable use; WP3);
  5. Develop an ethical framework describing practice-oriented ethical requirements (enable use) for generating and using patient-relevant RWD to support decision-making (WP4);
  6. Create an integrated More-EUROPA framework, incorporating methodological tools and ethical considerations, to favour adoption and use of RWE across the drug lifecycle in regulatory & HTA guidelines and decision-making (WP5);
  7. Increase the skills and competencies of HTA staff and regulators towards the use of RWD (favour adoption and use) through interactive multi-stakeholder training sessions (WP6);
  8. Create an integrated multi-stakeholder platform for RWD/RWE engaging and aligning with other European programs and initiatives (favour adoption and use) (WP6).

This will ultimately decrease the costs associated to drug development/licensing and speed up the accessibility and reimbursement of drugs to European people/patients in need