Rethinking clinical trials for medical AI with dynamic deployments of adaptive systems
Open accessAbstract
There is a growing recognition of the need for clinical trials to safely and effectively deploy artificial intelligence (AI) in clinical settings. We introduce dynamic deployment as a framework for AI clinical trials tailored for the dynamic nature of large language models, making possible complex medical AI systems which continuously learn and adapt in situ from new data and interactions with users while enabling continuous real-time monitoring and clinical validation.
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The existence of such frameworks does not ensure robust post-deployment oversight in routine care.
“However, the existence of such frameworks does not ensure robust post-deployment oversight in routine care”
From Beyond Model Development in Healthcare AI: Post-Development Robustness, Post-Deployment Monitoring, and Lifecycle Governance—A Scoping Review of Reviews (2026) · cites this paper as [16]
Uptake of formal guidance in clinical AI trials remains incomplete.
“and uptake of formal guidance in clinical AI trials remains incomplete [15,16].”
From Beyond Model Development in Healthcare AI: Post-Development Robustness, Post-Deployment Monitoring, and Lifecycle Governance—A Scoping Review of Reviews (2026) · cites this paper as [16]
The References list identifies the CONSORT-AI and SPIRIT-AI guidance, and the Existing precedent section says those guidelines excluded continuously learning trial designs. Neither passage addresses how often clinical AI trials follow formal guidance (searched for guideline uptake, adoption, and compliance). (LLM, conf=0.72)
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- Authors
- Rosenthal, J. T., Beecy, A., & Sabuncu, M. R.
- Affiliations
- Weill Cornell Medicine (US)
- Cornell University (US)
- Corresponding author
- Rosenthal, Jacob T.
- Venue
- npj Digital Medicine
- Published
- 2025-05-06
- Volume
- 8
- Issue
- 1
- Pages
- 252-252
- ISSN
- 2398-6352 (ISSN-L)
- PMC
- PMC12056174
- OpenAlex
- W4410111118
- Cited by
- 59
- References
- 54
- Citations by year
- 2026: 41 · 2025: 18
- FWCI
- 3.49
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- npj Digital Medicine (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Institute of General Medical Sciences (T32GM152349)
- Topics
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Physical Sciences › Computer Science › Artificial Intelligence › Machine Learning in Healthcare
- Physical Sciences › Engineering › Safety, Risk, Reliability and Quality › Safety Systems Engineering in Autonomy
- Keywords
- clinical trials, artificial intelligence in healthcare, dynamic deployment, adaptive systems, large language models, continuous learning, real-time monitoring, clinical validation, AI safety
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