RECITE: Revising Eligibility Criteria Incorporating Textual Evidence
TL;DR
This work introduces RECITE (Revising Eligibility Criteria Incorporating Textual Evidence), a framework for automated discovery, extraction, and implementation of evidence-based eligibility criteria revisions and suggests that existing clinical knowledge can be operationalized into actionable trial design recommendations.
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 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. 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 ?qw = 0.694 ± 0.096). The best open-weight model, Gemma 2 9B, achieves ?qw-aligned ordinal score 3.0 ± 0.9 on a 0-4 scale (normalized 0.742) and the best closed-weight model, GPT-4o, reaches 3.0 ± 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.
