Pharma’s next frontier: Can Europe’s drugmakers turn clinical reality into a catalyst for cancer breakthroughs?

Unlocking the Promise of Real-World Evidence in European Oncology
Pharma’s next frontier: Can Europe’s drugmakers turn clinical reality into a catalyst for cancer breakthroughs?

Brussels — As cancer rates continue to rise across Europe, pharmaceutical companies are facing increasing pressure to accelerate innovation in oncology. A growing chorus of experts believes the key may lie not in the lab — but in the real world.

Real-world evidence (RWE) — clinical insights drawn from data collected outside traditional randomized trials — has emerged as a critical tool for understanding how treatments perform in everyday settings. With cancer therapies becoming more personalized, and health systems increasingly data-rich, the question is no longer whether RWE is useful — but whether Europe’s pharma sector is ready to harness its full potential.

“RWE offers an opportunity to complement clinical trial results with insights from actual patient populations,” said Dr. Elena Rossi, head of oncology research at MedEurope Pharma. “Especially in oncology, where treatments can vary widely based on genetics, comorbidities, and care settings, this data is invaluable.”

The European Medicines Agency (EMA) has signaled openness to integrating RWE into regulatory decision-making, particularly for post-market surveillance and label expansions. Meanwhile, collaborations between pharma companies, hospital networks, and data analytics firms are growing — with platforms like EHDEN and DARWIN EU aiming to harmonize real-world data (RWD) across borders.

Yet challenges remain. Fragmented healthcare systems, varying data quality, and privacy regulations complicate efforts to build robust, scalable RWE infrastructures. “Europe has the advantage of rich data, but not yet the mechanisms to leverage it effectively,” noted Professor Jan Müller, a health economist at the University of Heidelberg.

Pharma executives agree the shift will require cultural as well as technical change. “We need to move from seeing RWE as secondary to clinical trials, to seeing it as a co-equal source of evidence,” said Lisette Berger, VP of Clinical Strategy at OncoNova Europe. “That means embedding RWE teams into early drug development — not as an afterthought.”

In oncology, the stakes are especially high. Immunotherapies and targeted agents often behave differently outside of controlled trial environments. Real-world data can reveal patterns of resistance, underperformance in certain subgroups, or unexpected long-term benefits — insights that can inform both clinical practice and future trial design.

Health systems, too, have a role to play. Some European nations are expanding cancer registries, mandating electronic health record (EHR) integration, and launching national data initiatives to bridge the RWE gap. But for true progress, a pan-European approach may be essential.

“If Europe wants to lead in oncology innovation, it must treat real-world data as a strategic asset,” said Dr. Charlotte Moreau of the Paris Oncology Centre. “Otherwise, we risk falling behind regions like the U.S. and China, where RWE is already shaping drug pipelines and reimbursement models.”

With cancer incidence projected to increase by nearly 25% in Europe by 2035, the urgency is clear. The path forward will require unprecedented collaboration between pharma, policymakers, clinicians, and patients. But if Europe’s pharmaceutical sector can unlock the full promise of real-world evidence, it could change the face of oncology care for generations to come.