Information Bias in Electronic Health Records and Administrative Claims Data: A Targeted Review of the Recent Literature

As real-world evidence (RWE) plays an increasingly significant role in regulatory and health technology assessment (HTA) decisions, concerns about information bias and measurement error persist as a major challenge. In this targeted literature review, published in Clinical Pharmacology and Therapeutics, researchers synthesize mitigation measures for information bias in RWE studies using electronic health records (EHRs) and administrative claims data.

Study Overview

The review examined 38 articles and guidance documents published between 2019 and 2024, including U.S.-based case studies and the U.S. Food and Drug Administration’s guidance on evaluating EHR and claims data. From these sources, the authors developed a 15-point framework spanning study design, variable definition, and statistical analysis, emphasizing validation, data linkage, and quantitative bias analysis. The framework offers practical recommendations to reduce information bias and strengthen the validity of RWE used in regulatory and HTA decision-making.

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