Several European countries have been utilizing big data together with randomized control trials to guide healthcare decision making and to address market access issues. The Region Europe RWE Advisory Board was formulated to explore potential areas of real world evidence (RWE) use in countries like UK, France, Portugal etc. The board engages stakeholders including payers, providers, and patient organizations with the intent of developing a platform and widening the community for RWE. The board has developed a three-year road map of initiatives for the enhanced use of RWE. The contributors are spread across the areas of licensing, commissioning and access, clinical decision-making and patient outcome decision-making to prioritize four key action points.

The priorities include:

  • Engage in early dialogue with payers on RWE needs
  • To develop consensus exercise on use of RWE in clinical decisions and develop a universal definition of patient related outcome (PRO) for active patient engagement
  • Focus on developing a model approach for data collection mapping, data quality assessment to appropriately collect PRO data.


A multi-stakeholder approach with international collaboration is essential to ensure robust RWE generation and utilization. It is imperative to enhance data availability together with formulation of a high-quality system for the real world evidence generation.