Work

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

Year: 2025

Type: article

Abstract: 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.

Source: European Journal of Cancer

DOI: 10.1016/j.ejca.2025.115790

Authors: Denis Lacombe, Fabio Borges, Stephanie Kromar, Bertrand Tombal

Institutions: European Organisation for Research and Treatment of Cancer, Cliniques Universitaires Saint-Luc

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology (medical)

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,270