The full implementation of Regulation (EU) No. 536/2014 has transformed the European clinical research landscape, introducing a harmonised, risk-based framework for trial approval and conduct. In Italy, however, the lack of nationally standardised site suitability criteria beyond phase I trials remains a critical regulatory gap, leading to procedural inconsistencies, delayed activations, and unequal patient access. This paper examines the shortcomings in European and Italian regulations and operations and suggests a tiered framework of minimum requirements for investigational centres. The model adjusts requirements based on trial complexity and associated risk, while ensuring compliance with EU legislation. This approach supports wider participation in pragmatic and late-phase oncology trials and prevents excessive centralisation in a few key hubs. It also emphasizes the need for formal recognition of essential research roles, such as study coordinators, data managers, and research pharmacists, critical to high-quality trials. By adopting this risk-adapted, scalable approach, national authorities could improve site qualification, streamline trial timelines, and enhance Italy’s competitiveness in international oncology research. From a policy standpoint, establishing proportionate national standards is urgent to ensure equitable patient access, strengthen the resilience of the research system, and align with the inclusive and risk-oriented spirit of Regulation (EU) No. 536/2014. Policy summary Italy lacks nationally standardised site suitability criteria beyond phase I clinical trials, causing delays and inequities. This paper proposes a risk-based, proportionate framework of minimum requirements for investigational sites, aligned with Regulation (EU) No. 536/2014. Adoption by AIFA would provide consistent benchmarks for Ethics Committees and sponsors, improve trial activation, and expand equitable access to innovative therapies, while reinforcing Italy’s role in multinational oncology research.
Investigational sites requirements according to trial complexity and intervention level under EU Regulation No. 536/2014
Cagnazzo, Celeste;Facciolo, Valeria;Daniele, Gennaro;Di Maio, Massimo;Pinto, Carmine
2025-01-01
Abstract
The full implementation of Regulation (EU) No. 536/2014 has transformed the European clinical research landscape, introducing a harmonised, risk-based framework for trial approval and conduct. In Italy, however, the lack of nationally standardised site suitability criteria beyond phase I trials remains a critical regulatory gap, leading to procedural inconsistencies, delayed activations, and unequal patient access. This paper examines the shortcomings in European and Italian regulations and operations and suggests a tiered framework of minimum requirements for investigational centres. The model adjusts requirements based on trial complexity and associated risk, while ensuring compliance with EU legislation. This approach supports wider participation in pragmatic and late-phase oncology trials and prevents excessive centralisation in a few key hubs. It also emphasizes the need for formal recognition of essential research roles, such as study coordinators, data managers, and research pharmacists, critical to high-quality trials. By adopting this risk-adapted, scalable approach, national authorities could improve site qualification, streamline trial timelines, and enhance Italy’s competitiveness in international oncology research. From a policy standpoint, establishing proportionate national standards is urgent to ensure equitable patient access, strengthen the resilience of the research system, and align with the inclusive and risk-oriented spirit of Regulation (EU) No. 536/2014. Policy summary Italy lacks nationally standardised site suitability criteria beyond phase I clinical trials, causing delays and inequities. This paper proposes a risk-based, proportionate framework of minimum requirements for investigational sites, aligned with Regulation (EU) No. 536/2014. Adoption by AIFA would provide consistent benchmarks for Ethics Committees and sponsors, improve trial activation, and expand equitable access to innovative therapies, while reinforcing Italy’s role in multinational oncology research.
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