128MO Impact of in-vitro diagnostic regulation (IVDR) implementation on authorization timelines and access to oncology clinical research

A. Matres Rojo; N. Farràs; Paula Chiquillo; M. Rotxes Costa; C. Perez Alonso; L. Cruz Ballús; S. Vázquez Vinuesa; E. Aliende; L. Saucedo Martin; E. Banus; A. Almodovar; Laia Catalan; A. Meire Barrio; O. Padros; Ana Vivancos; S. Aguilar Izquierdo; Josep Tabernero; E. Felip; A. Hernando Calvo; Elena Garralda

doi:10.1016/j.esmoop.2026.106270

Key Points

This research aims to evaluate how the IVDR affects the timeline for authorizing oncology clinical trials.
Analyzed authorization timelines for performance studies
Focused on a reference oncology clinical trial unit
Reviewed implications of IVDR on non-CE-marked diagnostic tests
IVDR has increased the complexity of CT submissions
Longer timelines for authorizations were observed
Access to oncology clinical research may be hindered due to regulatory changes

Implication

Analysis shows longer authorization timelines in oncology due to IVDR, suggesting reduced access to clinical research.

Abstract

The IVDR implementation has added complexity to CT submissions by requiring additional authorization of performance studies for non-CE-marked diagnostic tests. This study analyzes the impact of the IVDR in a reference oncology CT unit.

Discussion

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Cite This Study

Rojo et al. (2026) studied this question.

synapsesocial.com/papers/69cf5ea85a333a821460d21a https://doi.org/10.1016/j.esmoop.2026.106270

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128MO Impact of in-vitro diagnostic regulation (IVDR) implementation on authorization timelines and access to oncology clinical research

Key Points

Implication

Abstract

Discussion

Cite This Study

128MO Impact of in-vitro diagnostic regulation (IVDR) implementation on authorization timelines and access to oncology clinical research

Key Points

Implication

Abstract

Discussion

Cite This Study

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