# Critical appraisal of artificial intelligence for rare-event recognition: principles and pharmacovigilance case studies

arXiv: https://arxiv.org/abs/2510.04341 · HTML: https://mlsanity.com/paper/2510.04341/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 8 of its 41 references that are in the map.
- First posted on arXiv 5 Oct 2025.

## Builds on (most cited first, 8 of 8)

- [BERT: Pre-training of Deep Bidirectional Transformers for Language Understanding](https://mlsanity.com/paper/1810.04805/) (2018)
- [Language Models are Few-Shot Learners](https://mlsanity.com/paper/2005.14165/) (2020)
- [GPT-4 Technical Report](https://mlsanity.com/paper/2303.08774/) (2023)
- [Judging LLM-as-a-Judge with MT-Bench and Chatbot Arena](https://mlsanity.com/paper/2306.05685/) (2023)
- [Adapted Large Language Models Can Outperform Medical Experts in Clinical Text Summarization](https://mlsanity.com/paper/2309.07430/) (2023)
- [From Concept Drift to Model Degradation: An Overview on Performance-Aware Drift Detectors](https://mlsanity.com/paper/2203.11070/) (2022)
- [A Comprehensive Survey on Rare Event Prediction](https://mlsanity.com/paper/2309.11356/) (2023)
- [A Scalable Predictive Modelling Approach to Identifying Duplicate Adverse Event Reports for Drugs and Vaccines](https://mlsanity.com/paper/2504.03729/) (2025)

## Abstract (arXiv)

Many high-stakes AI applications target low-prevalence events, where apparent accuracy can conceal limited real-world value. Relevant AI models range from expert-defined rules and traditional machine learning to generative LLMs constrained for classification. We outline key considerations for critical appraisal of AI in rare-event recognition, including problem framing and test set design, prevalence-aware statistical evaluation, robustness assessment, and integration into human workflows. In addition, we propose an approach to structured case-level examination (SCLE), to complement statistical performance evaluation, and a comprehensive checklist to guide procurement or development of AI models for rare-event recognition. We instantiate the framework in pharmacovigilance, drawing on three studies: rule-based retrieval of pregnancy-related reports; duplicate detection combining machine learning with probabilistic record linkage; and automated redaction of person names using an LLM. We highlight pitfalls specific to the rare-event setting including optimism from unrealistic class balance and lack of difficult positive controls in test sets - and show how cost-sensitive targets align model performance with operational value. While grounded in pharmacovigilance practice, the principles generalize to domains where positives are scarce and error costs may be asymmetric.