Article

When AI Meets the FDA: An Evaluation of Large Language Models Performance in Regulatory and Clinical Trial Data Extraction, Synthesis, and Analysis

2025-12-27

Abstract excerpt

<h4>Introduction:</h4> Clinical and population decision-making relies on the systematic evaluation of extensive regulatory evidence. The FDA drug reviews provide detailed information on clinical trial design, enrollment criteria, sample size, randomization, comparators, endpoints, and indications. However, extracting these data is resource-intensive and time-consuming. Generative Artificial Intelligence large lan...

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Literature Corpus work: 46362abd-506b-5a1b-b6c7-276bcfb6aab0
DOI: 10.64898/2025.12.22.25342875

Open publication

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