Using large language models for safety-related table summarization in clinical study reports

Abstract Objectives The generation of structured documents for clinical trials is a promising application of large language models (LLMs). We share opportunities, insights, and challenges from a competitive challenge that used LLMs for automating clinical trial documentation. Materials and Methods As part of a challenge initiated by Pfizer (organizer), several teams (participant) created a pilot for generating summaries of safety tables for clinical study reports (CSRs). Our evaluation framework used automated metrics and expert reviews to assess the quality of AI-generated documents. Results The comparative analysis revealed differences in performance across solutions, particularly in factual accuracy and lean writing. Most participants employed prompt engineering with generative pre-trained transformer (GPT) models. Discussion We discuss areas for improvement, including better ingestion of tables, addition of context and fine-tuning. Conclusion The challenge results demonstrate the potential of LLMs in automating table summarization in CSRs while also revealing the importance of human involvement and continued research to optimize this technology.