RECITE: Revising Eligibility Criteria Incorporating Textual Evidence

Authors: Russell Ro , Reza Abbasi-Asl

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Abstract: Overly restrictive eligibility criteria contribute to widespread enrollment failure in clinical trials, yet published recommendations for how specific criteria should be broadened remain disconnected from trial design at scale. We introduce RECITE (Revising Eligibility Criteria Incorporating Textual Evidence), a framework for automated discovery, extraction, and implementation of evidence-based eligibility criteria revisions. RECITE uses protocol amendment documents from this http URL to construct a dataset of 11,913 curated instances across 5,735 trials, each pairing original criteria with documentary evidence and target revisions. We benchmark fifteen LLM configurations under truncated-to-context-window and retrieval-augmented generation conditions, on a 3,116-instance sample under an LLM-as-judge protocol validated against ten domain experts (judge vs. human quadratic-weighted Cohen's $\kappa_{qw} = 0.694 \pm 0.096$). The best open-weight model, Gemma 2 9B, achieves $\kappa_{qw}$-aligned ordinal score $3.0 \pm 0.9$ on a 0--4 scale (normalized 0.742) and the best closed-weight model, GPT-4o, reaches $3.0 \pm 0.8$ (normalized 0.745). Using an agentic literature discovery system, we then identified 44 paper--trial matches across five publications providing trial-design and EC-modification evidence. Our findings suggest that existing clinical knowledge can be operationalized into actionable trial design recommendations.

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18 pages, 4 figures, 4 tables. Extended version of a paper in KDD 2026 (32nd ACM SIGKDD Conference on Knowledge Discovery and Data Mining). Code and data: this https URL

Subjects:

Artificial Intelligence (cs.AI)

Cite as:

arXiv:2610.41368 [cs.AI]

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arXiv:2610.41368v1 [cs.AI] for this version)

https://doi.org/10.48550/arXiv.2610.41368

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arXiv-issued DOI via DataCite (pending registration)

Related DOI :

https://doi.org/10.1145/3770855.3819027

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From: Russell Ro [ view email ]

[v1]

Fri, 30 Oct 2026 07:34:50 UTC (314 KB)

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