Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems

Yoshihiro Noguchi () and Tomoaki Yoshimura ()
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Yoshihiro Noguchi: Gifu Pharmaceutical University
Tomoaki Yoshimura: Gifu Pharmaceutical University

Drug Safety, 2024, vol. 47, issue 6, No 4, 535-543

Abstract: Abstract Medical science has often used adult males as the standard to establish pathological conditions, their transitions, diagnostic methods, and treatment methods. However, it has recently become clear that sex differences exist in how risk factors contribute to the same disease, and these differences also exist in the efficacy of the same drug. Furthermore, the elderly and children have lower metabolic functions than adult males, and the results of clinical trials on adult males cannot be directly applied to these patients. Spontaneous reporting systems have become an important source of information for safety assessment, thereby reflecting drugs’ actual use in specific populations and clinical settings. However, spontaneous reporting systems only register drug-related adverse events (AEs); thus, they cannot accurately capture the total number of patients using these drugs. Therefore, although various algorithms have been developed to exploit disproportionality and search for AE signals, there is no systematic literature on how to detect AE signals specific to the elderly and children or sex-specific signals. This review describes signal detection using data mining, considering traditional methods and the latest knowledge, and their limitations.

Date: 2024
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DOI: 10.1007/s40264-024-01404-w

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