Poster De Conférence Année : 2025

Narrative review on the clinical evaluation of AI-based digital medical devices from a methodological perspective

Résumé

The rapid evolution of algorithms over time, the differences in performance between users and within user, the validity of digital evaluation criteria and the organizational impact are all examples of issues that are both diverse and more specific to digital medical devices (DMDs) compared to drugs. Furthermore, some DMDs using artificial intelligence (AI) have the particularity to be developed using continuous learning systems, in which the algorithms learn from all the data they are used on. Despites these features, their clinical evaluation often follows existing frameworks designed for drugs and thus tailored to non-evolutive non-complex health technologies. Nevertheless, the specific features of AI-based DMDs call for an adapted clinical evaluation approach and raise new methodological questions. We propose a narrative review of these characteristics and the challenges they could imply for the evaluation of DMD. Hence, AI-based DMD could be closer to human-based interventions as studied in field of population health intervention research. The definition of users and intended use, the choice of data sets for analytical and clinical validation, the specification of outcomes of interest, the use of real-world data studies in addition to randomized clinical trials, and the choice of appropriate comparator are all key elements that can influence the design, analysis and generalizability of the clinical assessment. To conclude, this review can be taken as a starting point to define the design choices and methodological resolution of the issues raised and thus propose a rigorous framework for the clinical evaluation of AI-based DMDs.

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Dates et versions

hal-05364943 , version 1 (14-11-2025)

Identifiants

  • HAL Id : hal-05364943 , version 1

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Sandrine Boulet, Vincent Thévenet, Judith Abécassis, Corinne Collignon, Bruno Giraudeau, et al.. Narrative review on the clinical evaluation of AI-based digital medical devices from a methodological perspective. SbN 2025 - 10th Statistics & Biopharmacy Conference, Oct 2025, Paris, France. ⟨hal-05364943⟩
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