Retrieval Augmented Generation (RAG) for Evaluating Regulatory Compliance of Drug Information and Clinical Trial Protocols
Abstract
The purpose was to evaluate retrieval‐augmented generative (RAG) artificial intelligence (AI) methods for assessing the regulatory compliance of drug information and adherence to best practices in clinical trial protocols. Integrated systems containing RAG and large language model (LLM) components were employed to evaluate drug information and clinical trial protocols. The drug information for adalimumab, insulin glargine, atorvastatin calcium, sertraline, and alprazolam was evaluated for compliance with Food and Drug Administration (FDA) clinical pharmacology guidance for indications, use in specific populations, and warnings and precautions. The reasons for the withdrawal of rofecoxib, valdecoxib, and troglitazone were elicited. The clinical trial protocol evaluation system was used to assess a Phase‐2a clinical trial protocol of Rifafour in tuberculosis with the FDA E9 and E9 (R1) guidance documents. The RAG system correctly identified the indications, use in specific populations, and warnings and precautions for adalimumab, insulin glargine, atorvastatin calcium, sertraline, and alprazolam. The drug information was evaluated against the requirements in the guidance documents, confirming compliance when present and providing explanations for deficiencies. The causes underlying the withdrawal of rofecoxib, valdecoxib, and troglitazone were explained. The clinical protocol summary included study design, population definitions, treatments, dose levels, and route of…
Read the paper
Related studies
- Knowledge Management Perspective of Generative Artificial Intelligence
- Navigating Generative Artificial Intelligence Promises and Perils for Knowledge and Creative Work
- Characterizing the evolving research on enterprise content management
- Large language models and multimodal foundation models for precision oncology
- From Generative AI to Extended Reality: Multidisciplinary Perspectives on the Challenges, Opportunities, and Future of Educational Computing
- Generative Artificial Intelligence: A New Engine for Advancing Environmental Science and Engineering
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.