Evaluating artificial intelligence in medicine: phases of clinical research

JAMIA Open
Yoonyoung ParkAmar K Das

Abstract

Increased scrutiny of artificial intelligence (AI) applications in healthcare highlights the need for real-world evaluations for effectiveness and unintended consequences. The complexity of healthcare, compounded by the user- and context-dependent nature of AI applications, calls for a multifaceted approach beyond traditional in silico evaluation of AI. We propose an interdisciplinary, phased research framework for evaluation of AI implementations in healthcare. We draw analogies to and highlight differences from the clinical trial phases for drugs and medical devices, and we present study design and methodological guidance for each stage.

References

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Citations

Nov 17, 2020·Health Information Science and Systems·Marjo Rissanen
Feb 1, 2021·Journal of the American Medical Informatics Association : JAMIA·Suthida SuwanvechoNarongsak Kiatikajornthada
May 1, 2021·Cancer Cell·Benjamin H KannHugo J W L Aerts
May 8, 2021·Cancer Medicine·Isaac S ChuaMichael Hassett
Aug 26, 2021·Academic Medicine : Journal of the Association of American Medical Colleges·Jai Prashar
Aug 26, 2021·Academic Medicine : Journal of the Association of American Medical Colleges·Thomas Robert Savage
Oct 4, 2021·BMC Medical Informatics and Decision Making·Rosy TsopraAnita Burgun

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