Advancing Healthcare: The Role of Real-World Evidence in Decision-Making

By Danélia Botes

April 25, 2024


Real-world evidence (RWE) plays a crucial role in the continuously evolving healthcare landscape. It shapes our understanding and application of medical treatments. As healthcare systems aim for precision and personalisation, they look to RWE for guidance. It lights the way to more informed decisions and improved patient outcomes.

The Emergence of Real-World Evidence

The healthcare sector recognises the limitations of traditional clinical trials. Particularly when it comes to rapidly approved medicines for niche patient groups. Real-world evidence provides a complementary narrative, one that captures the effectiveness of treatments in diverse, everyday settings. This evidence is crucial for Health Technology Assessment (HTA) bodies, as it can reduce uncertainties and expedite reimbursement decisions.

The Challenges of Harnessing Big Data

However, despite its potential, creating robust RWE is fraught with challenges. The sheer volume of data, coupled with source heterogeneity and standardisation issues, complicates its use in regulatory decision-making. This is where innovative projects, such as those funded by the European Commission’s Horizon Europe program, come into play.

Spotlight on Horizon Europe’s Trailblazing Projects

The MetReal Cluster, a collective of five pivotal projects under Horizon Europe, epitomises the EU’s dedication to refining data-driven methodologies. These projects, including Real4Reg and More-EUROPA, lead the integration of RWE and artificial intelligence (AI) into drug development and regulatory processes. Here’s a brief overview of each initiative:

  • Real4Reg: Utilising AI to analyse RWD, this project aims to strengthen the acceptance and impact of real-world and synthetic data throughout the product lifecycle.
  • More-EUROPA: By integrating evidence from RCTs and RWD, this project aspires to streamline drug development, making it more efficient and cost-effective.
  • REDDIE: Focusing on diabetes care, REDDIE employs machine learning to enhance data analysis and set RWE standards, aiming to improve data augmentation.
  • REALM: Concentrating on medical device software, REALM is working to simplify data location and standardise evaluations for innovative health solutions.
  • ONCOVALUE: Specialising in cancer therapy evaluations, ONCOVALUE merges hospital data with clinical outcomes and patient-reported metrics to advance cancer treatment decisions.

The Future of Real-World Evidence in Healthcare

The integration of real-world evidence into healthcare decision-making is a collective endeavour, with each project contributing to a larger vision. In short, the shared objective is clear: to leverage RWE for more effective, personalised healthcare. Stakeholder collaboration, innovative initiatives, diverse medical applications, along with advanced technologies like AI are the pillars of this transformative movement. The patient-centric approach remains paramount, ensuring that real-world evidence serves the needs and improves the outcomes of those at the heart of healthcare.


Real-world evidence is redefining the healthcare industry, offering new perspectives on treatment efficacy and safety. Therefore, as these Horizon Europe-funded projects advance, their impact is set to extend beyond European borders, influencing global healthcare practices. With an eye on the horizon, the promise of real-world evidence is one of a more nuanced, effective, and patient-focused healthcare system.

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