Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments

Jürgen Dietrich () and André Hollstein
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Jürgen Dietrich: Bayer AG
André Hollstein: Bayer AG

Drug Safety, 2025, vol. 48, issue 3, No 8, 287-303

Abstract: Abstract Introduction Recent artificial intelligence (AI) advances can generate human-like responses to a wide range of queries, making them a useful tool for healthcare applications. Therefore, the potential use of large language models (LLMs) in controlled environments regarding efficacy, reproducibility, and operability will be of paramount interest. Objective We investigated if and how GPT 3.5 and GPT 4 models can be directly used as a part of a GxP validated system and compared the performance of externally hosted GPT 3.5 and GPT 4 against LLMs, which can be hosted internally. We explored zero-shot LLM performance for named entity recognition (NER) and relation extraction tasks, investigated which LLM has the best zero-shot performance to be used potentially for generating training data proposals, evaluated the LLM performance of seven entities for medical NER in zero-shot experiments, selected one model for further performance improvement (few-shot and fine-tuning: Zephyr-7b-beta), and investigated how smaller open-source LLMs perform in contrast to GPT models and to a small fine-tuned T5 Base. Methods We performed reproducibility experiments to evaluate if LLMs can be used in controlled environments and utilized guided generation to use the same prompt across multiple models. Few-shot learning and quantized low rank adapter (QLoRA) fine-tuning were applied to further improve LLM performance. Results and Conclusion We demonstrated that zero-shot GPT 4 performance is comparable with a fine-tuned T5, and Zephyr performed better than zero-shot GPT 3.5, but the recognition of product combinations such as product event combination was significantly better by using a fine-tuned T5. Although Open AI launched recently GPT versions to improve the generation of consistent output, both GPT variants failed to demonstrate reproducible results. The lack of reproducibility together with limitations of external hosted systems to keep validated systems in a state of control may affect the use of closed and proprietary models in regulated environments. However, due to the good NER performance, we recommend using GPT for creating annotation proposals for training data as a basis for fine-tuning.

Date: 2025
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DOI: 10.1007/s40264-024-01499-1

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