CPE, with the European Organisation for Research and Treatment of Cancer (EORTC), is proud to announce the launch of the White Paper: “Embedding Treatment Optimisation and Pragmatic Clinical Trials in EU Cancer Research Policy.”
The White Paper calls for a shift in how cancer treatments are evaluated after they reach the market. While traditional regulatory trials remain essential for securing approval, they often fail to answer the practical questions that matter most to patients and clinicians in daily care. Treatment Optimisation (TO) studies, conducted through Pragmatic Clinical Trials (PCTs), can bridge this gap by determining how therapies should best be used in real-life settings—addressing questions such as treatment duration, dosage, sequencing, and quality-of-life impact
This white paper calls for the integration of TO and PCTs into EU cancer research, alongside reforms to the EU Pharmaceutical Legislation, to advance a more patient-centered research model that strengthens both patient outcomes and the sustainability of healthcare systems. Key recommendations include:
- Embedding Treatment Optimisation as a formal stage of research in EU pharmaceutical policy.
- Encouraging Post-Licensing Trials in routine clinical practice to generate real-world evidence.
- Ensuring meaningful patient involvement in the design and evaluation of studies.
- Securing public funding for studies that serve the public interest, such as testing lower doses or simplified regimens that reduce side effects and costs.
The White Paper will be officially launched at the event “Treatment Optimisation: Making Cancer Treatment Accessible and Sustainable in Europe” at the European Parliament on 24 September 2025, 15:00–17:00 CEST (SPINELLI A3H1, Brussels). The programme will feature a high-level discussion on how to ensure therapies are used optimally across Europe.
Our CEO, Antonella Cardone, will present the patient perspective during the panel discussion, highlighting why Treatment Optimisation is crucial for ensuring that patients not only gain access to innovation but also benefit from the best possible treatment outcomes.
At CPE, we are committed to making the voices of patients heard at every stage of cancer research and policy. With this White Paper, we reaffirm our dedication to building a European cancer research model that is inclusive, evidence-driven, and truly centred on patients’ needs. By embedding Treatment Optimisation into European research and policy frameworks, we can ensure that every cancer therapy delivers maximum value for patients and health systems alike.
