PMID- 38388828
OWN - NLM
STAT- Publisher
LR  - 20240222
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
DP  - 2024 Feb 22
TI  - Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting 
      Systems.
LID - 10.1007/s40264-024-01404-w [doi]
AB  - 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.
CI  - (c) 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Noguchi, Yoshihiro
AU  - Noguchi Y
AUID- ORCID: 0000-0002-9110-9604
AD  - Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, 
      Daigakunishi, Gifu, 501-1196, Japan. noguchiy@gifu-pu.ac.jp.
FAU - Yoshimura, Tomoaki
AU  - Yoshimura T
AD  - Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, 
      Daigakunishi, Gifu, 501-1196, Japan.
LA  - eng
GR  - 22K12890/JSPS KAKENHI/
PT  - Journal Article
PT  - Review
DEP - 20240222
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
EDAT- 2024/02/23 00:42
MHDA- 2024/02/23 00:42
CRDT- 2024/02/22 23:56
PHST- 2024/02/04 00:00 [accepted]
PHST- 2024/02/23 00:42 [medline]
PHST- 2024/02/23 00:42 [pubmed]
PHST- 2024/02/22 23:56 [entrez]
AID - 10.1007/s40264-024-01404-w [pii]
AID - 10.1007/s40264-024-01404-w [doi]
PST - aheadofprint
SO  - Drug Saf. 2024 Feb 22. doi: 10.1007/s40264-024-01404-w.