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Convergence of science, regulations and society in cancer clinical research: A perspective based on the EORTC
Denis Lacombe1, Fabio Borges1, Stephanie Kromar1
1EORTC Headquarters, Brussels, Belgium.
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.
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