Faithful by Design: Evaluating and Improving LLM-Generated Clinical Trial Summaries for Multi-Stakeholder Audiences
TL;DR
A benchmark evaluation framework for measuring the faithfulness of LLM-generated clinical trial summaries across three stakeholder audiences is introduced and a knowledge-graph-augmented retrieval system was developed and evaluated, producing statistically significant improvements in NLI-based faithfulness scores.
Abstract
Large language models are increasingly used to summarize clinical trial results for healthcare providers, patients, and payers, but their tendency to hallucinate poses significant risks in this high-stakes context. This study introduces a benchmark evaluation framework for measuring the faithfulness of LLM-generated clinical trial summaries across three stakeholder audiences. The framework consists of 200 stratified trials drawn from the Aggregate Analysis of ClinicalTrials.gov database, evaluated using audience-specific prompt templates and a six-dimension faithfulness annotation schema. Baseline measurements were established for GPT-4o, Claude Sonnet 4.6, and Gemini 2.5 Flash across 1,800 generated summaries scored using a cross-encoder natural language inference (NLI) model. Unsupported Claims was identified as the dominant failure mode across all three models, with a mean annotation score of 1.55 out of three. A knowledge-graph-augmented retrieval system was developed and evaluated against the baseline, producing statistically significant improvements in NLI-based faithfulness scores (entailment +0.0125, faithfulness +0.0130, p<0.0001). Improvement pathways were model-dependent, with GPT-4o improving primarily through contradiction reduction while Claude Sonnet 4.6 and Gemini 2.5 Flash improved through increased entailment.