Convergence of science, regulations and society in cancer clinical research: A perspective based on the EORTC DE-ESCALATE Study.

Recent or upcoming regulations are significantly shaping the European clinical research landscape. Assessing their impact is crucial to ensure pragmatic implementation and identify areas requiring legislative refinement. The DE-ESCALATE trial, addressing treatment optimisation for prostate cancer, highlights key challenges in applying current regulatory frameworks, particularly regarding their suitability for pragmatic, patient-centred clinical research. Advancing clinical research to facilitate access to treatment in the EU demands urgent engagement from policymakers to implement risk-based and proportionate regulations, enabling all types of clinical trials.