Faithful by Design: Evaluating and Improving LLM-Generated Clinical Trial Summaries for Multi-Stakeholder Audiences
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.