Embedding Treatment Optimisation and Pragmatic Clinical Trials in EU Cancer Research Policy: Call to Action

Embedding Treatment Optimisation and Pragmatic Clinical Trials in EU Cancer Research Policy: Call to Action

This Call to Action, led by Cancer Patients Europe and co-signed by patient organisations, healthcare professionals, scientific societies, and academic researchers, urges EU institutions and Member States to embed Treatment Optimisation (TO) and Pragmatic Clinical Trials (PCTs) into EU pharmaceutical and clinical research policy. It argues that current regulatory trial models fail to reflect real-world patient needs, exclude diverse populations, and rely on surrogate endpoints. The document calls for specific legislative reforms within the ongoing EU pharmaceutical legislation revision to create a patient-centred post-licensing research framework in oncology.