Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR–Guided Scoping Review of Global Guidance and Evidence (2017–2025)

Abstract

: Evidence and regulatory expectations for AIaMD remain fragmented. Harmonization of terminology, trial design principles, and post-market governance-supported by standardized reporting-would improve clinical validity, safety assurance, and scalability across regions. This review has several limitations. As a scoping synthesis, it prioritizes breadth of coverage rather than quantitative meta-analysis. Included sources vary in methodological rigor and reporting detail, and evolving regulatory guidance may change rapidly over time. Nevertheless, integrating peer-reviewed and regulatory evidence provides a comprehensive overview of current expectations and emerging gaps. In conclusion, effective evaluation of AIaMD requires a shift from static, one-time validation toward continuous lifecycle oversight that integrates adaptive trial designs, transparent reporting standards, bias surveillance, and structured post-market monitoring. Regulatory heterogeneity currently poses significant barriers to multinational development; however, coordinated adoption of standardized evidence frameworks and collaborative governance mechanisms may reduce duplication while preserving patient safety. By translating methodological principles into operational guidance, this review aims to support regulators, sponsors, and clinical investigators in designing trials that are both scientifically rigorous and practically implementable for continuously learning systems.

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