AI-assisted Protocol Information Extraction For Improved Accuracy and Efficiency in Clinical Trial Workflows

Abstract

Increasing clinical trial protocol complexity, amendments, and challenges around knowledge management create significant burden for trial teams. Structuring protocol content into standard formats has the potential to improve efficiency, support documentation quality, and strengthen compliance. We evaluate an Artificial Intelligence (AI) system using generative LLMs with Retrieval-Augmented Generation (RAG) for automated clinical trial protocol information extraction. We compare the extraction accuracy of our clinical-trial-specific RAG process against that of publicly available (standalone) LLMs. We also assess the operational impact of AI-assistance on simulated extraction CRC workflows. Our RAG process was measured as more accurate (87.8%) than standalone LLMs with fine-tuned prompts (62.6%) against expert-supported reference annotations. In the simulated extraction workflows, AI-assisted tasks were completed 40% faster, rated as less cognitively demanding and strongly preferred by users. While expert oversight remains essential, this suggests that AI-assisted extraction can enable protocol intelligence at scale, motivating the integration of similar methodologies into real world clinical workflows to further validate its impact on feasibility, study start-up, and post-activation monitoring.