Automated Detection of Dosing Errors in Clinical Trial Narratives: A Multi-Modal Feature Engineering Approach with LightGBM

Medication errors, particularly dosing errors in clinical trials (CT), can lead to patient harm, adverse drug events and worse patient outcomes. Dosing errors are preventable, and early identification can improve trial integrity and mitigate subsequent clinical and financial burden. This study aims to detect dosing errors within CT protocols by evaluating text representations of trial information using transformer-based language models trained on biomedical corpora. CT textual data was encoded using several models, including ClinicalBERT, PubMedBERT, BioBERT, and MedCPT, and integrated with categorical features. These text embeddings were used as input to classical machine learning models and neural network architectures within an experimental framework. Performance was primarily assessed using ROC-AUC with respect to predicting dosage error. Under a logistic regression baseline, BioBERT consistently outperformed alternative encoders, achieving an ROC-AUC of 0.794, a 3.95% improvement over the ClinicalBERT baseline. Combining multiple embeddings did not yield improvements, indicating that domain alignment outweighs representational stacking. Gradient boosting models, support vector classifiers, logistic regression, and residual neural networks achieved the strongest performance for predicting dosage error, achieving ROC-AUCs: 0.821 to 0.853. Overall, the integration of domain-specific transformer embeddings with structured metadata enables discrimination of trials meeting a predefined elevated dosing error risk criterion, advancing safety monitoring and supporting informed regulatory decision-making.

Objective: The objective of this study is to develop a machine learning (ML)-based framework for early risk stratification of clinical trials (CTs) according to their likelihood of exhibiting a high rate of dosing errors, using information available prior to trial initiation. Materials and Methods: We constructed a dataset from ClinicalTrials.gov comprising 42,112 CTs. Structured, semi-structured trial data, and unstructured protocol-related free-text data were extracted. CTs were assigned binary labels indicating elevated dosing error rate, derived from adverse event reports, MedDRA terminology, and Wilson confidence intervals. We evaluated an XGBoost model trained on structured features, a ClinicalModernBERT model using textual data, and a simple late-fusion model combining both modalities. Post-hoc probability calibration was applied to enable interpretable, trial-level risk stratification. Results: The late-fusion model achieved the highest AUC-ROC (0.862). Beyond discrimination, calibrated outputs enabled robust stratification of CTs into predefined risk categories. The proportion of trials labeled as having an excessively high dosing error rate increased monotonically across higher predicted risk groups and aligned with the corresponding predicted probability ranges. Discussion: These findings indicate that dosing error risk can be anticipated at the trial level using pre-initiation information. Probability calibration was essential for translating model outputs into reliable and interpretable risk categories, while simple multimodal integration yielded performance gains without requiring complex architectures. Conclusion: This study introduces a reproducible and scalable ML framework for early, trial-level risk stratification of CTs at risk of high dosing error rates, supporting proactive, risk-based quality management in clinical research.

Errors in medical text can cause delays or even result in incorrect treatment for patients. Recently, language models have shown promise in their ability to automatically detect errors in medical text, an ability that has the opportunity to significantly benefit healthcare systems. In this paper, we explore the importance of prompt optimisation for small and large language models when applied to the task of error detection. We perform rigorous experiments and analysis across frontier language models and open-source language models. We show that automatic prompt optimisation with Genetic-Pareto (GEPA) improves error detection over the baseline accuracy performance from 0.669 to 0.785 with GPT-5 and 0.578 to 0.690 with Qwen3-32B, approaching the performance of medical doctors and achieving state-of-the-art performance on the MEDEC benchmark dataset. Code available on GitHub: https://github.com/CraigMyles/clinical-note-error-detection