Article

From Protocol to Analysis Plan: Development and Validation of a Large Language Model Pipeline for Statistical Analysis Plan Generation using Artificial Intelligence (SAPAI)

2026-03-19

Abstract excerpt

<h4>Background</h4> Statistical Analysis Plans (SAPs) are essential for trial transparency and credibility but are resource-intensive to produce. While Large Language Models (LLMs) have shown promise in drafting protocols, their ability to generate high-quality, protocol-compliant SAPs remains untested against current content guidance. This study developed and validated an LLM-based pipeline for drafting SAPs fro...

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Literature Corpus work: d0085034-7c99-558f-aaa8-be9dee5b4ca3
DOI: 10.64898/2026.03.19.26348626

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