Cited by 150Artificial Intelligence in Healthcare and EducationArtificial Intelligence in HealthcareEthics and Social Impacts of AI

Evaluating artificial intelligence in medicine: phases of clinical research

Open access
Park, Yoonyoung, Jackson, Gretchen Purcell, Foreman, Morgan A, Gruen, Daniel, Hu, Jianying, Das, Amar K·2020·JAMIA Open

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.

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Crossref · 10.1093/jamiaopen/ooaa033

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  • Successful pilot deployments act as a springboard for broader adoption.

    “Successful pilot deployments act as a springboard for broader adoption [58].”

    From Use of artificial intelligence in critical care: opportunities and obstacles (2024) · cites this paper as [58]

    Table 1 (Introduction, ‘AI versus AI implementation in healthcare’; page unavailable) lists a clinical pilot study as a phase 2 evaluation method. The ‘Phase 2: Efficacy and side effects’ section says validated improvements can justify larger phase 3 trials, but it does not say successful pilot deployments lead to broader adoption. (LLM, conf=0.81)

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Research works printed but not linked: 4

  1. [21]Core MG, Lane HC, van Lent M, Gomboc D, Solomon S, Rosenberg M. Building explainable artificial intelligence systems. In: Proceedings of the 18th Conference on Innovative Applications of Artificial Intelligence, vol. 2; 2006; 1766– 73.
  2. [32]Liao QV, Gruen D, Miller S. Questioning the Ai: toward design practices for explainable AI user experiences.In: proceedings of the 2020 CHI Conference on Human Factors in Computing Systems; 2020.
  3. [33]Saleiro P, Kuester B, Hinkson L, et al Aequitas: a bias and fairness audit toolkit. arXiv: 1811.05577. 2018. · arXiv
  4. [34]Bellamy RKE, Dey K, Hind M, et al AI fairness 360: an extensible toolkit for detecting, understanding, and mitigating unwanted algorithmic bias. arXiv: 1810.01943. 2018. · arXiv

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Authors
Park, Y., Jackson, G. P., Foreman, M. A., Gruen, D., Hu, J., & Das, A. K.
Affiliations
  • IBM Research - Cambridge (United States) (US)
  • IBM (United States) (US)
  • IBM Research - Thomas J. Watson Research Center (US)
Corresponding author
Park, Yoonyoung
Venue
JAMIA Open
Published
2020-09-08
Volume
3
Issue
3
Pages
326-331
ISSN
2574-2531 (ISSN-L)
OpenAlex
W3083901094
Cited by
150
References
34
Citations by year
2026: 19 · 2025: 26 · 2024: 33 · 2023: 35 · 2022: 20 · 2021: 15 · 2020: 2
FWCI
5.30
Type
journal article
Language
en
Open access
Locations
  • JAMIA Open (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Health Sciences › Health Professions › Health Information Management › Artificial Intelligence in Healthcare
  • Social Sciences › Safety Research › Ethics and Social Impacts of AI
Keywords
artificial intelligence in healthcare, AI evaluation, clinical trial phases, research design, real-world effectiveness, unintended consequences, AI implementation

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