Convergence of science, regulations and society in cancer clinical research: A perspective based on the EORTC DE-ESCALATE Study.
(2025) European journal of cancer (Oxford, England : 1990) — Vol. 229, p. 115790 (2025)
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- 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.
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Citations
Lacombe, D., Borges, F., Kromar, S., & Tombal, B. (2025). Convergence of science, regulations and society in cancer clinical research: A perspective based on the EORTC DE-ESCALATE Study. European journal of cancer (Oxford, England : 1990), 229, 115790. https://doi.org/10.1016/j.ejca.2025.115790 (Original work published 2025)