Ensuring Reliability of Curated Electronic Health Record-Derived Data: The Validation of Accuracy for Large Language...

Large language models (LLMs) are increasingly used to extract clinical data from electronic health records, offering significant improvements in scalability and efficiency for real-world data (RWD) curation in oncology. However, the adoption of LLMs introduces new challenges in ensuring the reliability, accuracy, and fairness of extracted data, which are essential for research, regulatory, and clinical applications. Existing quality assurance frameworks for RWD and artificial intelligence (AI) do not fully address the unique error modes and complexities associated with LLM-extracted data. In this paper, we propose a comprehensive framework for evaluating the quality of clinical data extracted by LLMs. The framework integrates variable-level performance benchmarking against expert human abstraction, verification checks for internal consistency and plausibility, and replication analyses comparing LLM-extracted data to human-abstracted data sets or external standards. This multidimensional approach enables the identification of variables most in need of improvement, systematic detection of latent errors, and confirmation of data set fitness-for-purpose in real-world research. Additionally, the framework supports bias assessment by stratifying across demographic subgroups. By providing a rigorous and transparent method for assessing LLM-extracted RWD, this framework advances industry standards and supports the trustworthy use of AI-powered evidence generation in oncology research and practice.