RECITE: Revising Eligibility Criteria Incorporating Textual Evidence

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 $\kappa_{qw} = 0.694 \pm 0.096$). It comes from a paper posted to arXiv on 2 November 2026. 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 ClinicalTrials.gov to construct a dataset of 11,913 curated instances across 5,735 trials, each pairing original criteria with documentary evidence and target revisions. 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.

Why it counts

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 $\kappa_{qw} = 0.694 \pm 0.096$).

Sources

Primary source: primary source

What is not known

This brief does not claim independent replication. Claims that appear only on X and not in the primary source stay unknown.