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

Large language models (LLMs) have shown promise on summarization tasks, but they often produce hallucinations, which are unsupported or incorrect statements that limit their reliability in specialized healthcare applications. We introduce Hallucination Detection Guided Self-Refinement (HDSR), an inference-time method that leverages hallucination detectors to guide iterative summary revisions toward factual corrections. Building on this, we propose HDSR for Preference Learning (HDSR-PL), which converts detector-guided refinement trajectories into preference pairs for model finetuning. Extensive experiments show that our methods substantially reduce hallucinations for Llama and Gemma models in summarizing real-world clinical notes from MIMIC-IV-Note v2.2. For example, HDSR reduces 24% and HDSR-PL reduces 48% hallucinations in Llama-3.1-8B-Instruct. Importantly, both methods preserve summary fluency, coherence, and relevance according to human expert and LLM-Jury evaluations. Together, these results demonstrate that detection-informed refinement and preference learning offer an automated solution for improving factual faithfulness in clinical summarization.

Large language models (LLMs) are increasingly used for medical summarization, but their outputs can omit medically important information and introduce unsupported claims. Existing error-detection methods produce heuristic or uncalibrated scores, providing no formal control over missed errors and no principled way to trade off safety against clinician review burden. We introduce Conformal Assessment for Risk Evaluation (CARE), a post-hoc, model-agnostic safety layer that uses conformal risk control to overlay calibrated omission and hallucination flags onto summaries from any LLM without retraining. CARE provides finite-sample, distribution-free guarantees through two controllers: a hallucination controller that bounds the probability of a document containing any unflagged hallucinated sentence, and an omission controller that bounds the expected fraction of important omissions not surfaced for review. Unlike hallucination detection, omissions depend jointly on whether a source sentence is important and whether it is covered by the summary. We show that calibrating only one dimension can violate the target risk bound, while marginal decompositions remain valid but overly conservative. By jointly calibrating over the full $(τ,γ)$ threshold space, CARE preserves formal guarantees while surfacing up to 5$\times$ fewer sentences than alternative calibrated baselines. Across five medical summarization tasks, CARE satisfies the target risk bound at $α= 0.15$ with 95% confidence across 100 calibration/test resplits, using only ~100 labeled documents per domain. In a preliminary clinician study (75 document reviews), calibrated flags improved omission detection by 28.6 percentage points on average. These results show that sentence-level safety guarantees are feasible for LLM-assisted medical summarization and offer a tunable mechanism for balancing residual risk and review effort.

Evaluation of faithfulness of text summarization treats a model generated summary as faithful only if every of its sentences is supported by the source document: a strict conjunctive rule under which a single unsupported sentence makes the whole summary unfaithful. Yet most faithfulness benchmarks collect only one global human annotation label per summary. We ask whether such global human labels actually implement the conjunctive rule. We hypothesize that annotators may accept a summary as faithful when most sentences are faithful, not only when all are faithful. To test our hypothesis, we use five large language model (LLM) judges as per-sentence raters across four widely used faithfulness benchmarks. We find that global human labels correlate better with the average of per-sentence LLM judgments than with the implementation of the strict conjunctive rule. A manual review confirms that a substantial fraction of summaries labeled faithful by humans contain genuine local factual errors. We call this tendency Averaging Bias. Our results reveal that human labels on widely used faithfulness benchmarks contain measurable Averaging Bias, calling for carefully structured designs for trustworthy human annotations