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Yoshihiro Noguchi, Tomoya Tachi, Hitomi Teramachi
Continuous evaluation of drug safety is needed following approval to determine adverse events (AEs) in patient populations with diverse backgrounds. Spontaneous reporting systems are an important source of information for the detection of AEs not identified in clinical trials and for safety assessments that reflect the real-world use of drugs in specific populations and clinical settings. The use of spontaneous reporting systems is expected to detect drug-related AEs early after the launch of a new drug. Spontaneous reporting systems do not contain data on the total number of patients that use a drug; therefore, signal detection by disproportionality analysis, focusing on differences in the ratio of AE reports, is frequently used. In recent years, new analyses have been devised, including signal detection methods focused on the difference in the time to onset of an AE, methods that consider the patient background and those that identify drug-drug interactions. However, unlike commonly used statistics, the results of these analyses are open to misinterpretation if the method and the characteristics of the spontaneous reporting system cannot be evaluated properly. Therefore, this review describes signal detection using data mining, considering traditional methods and the latest knowledge, and their limitations.
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Noguchi, Y., Tachi, T., & Teramachi, H. (2021). Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source. Briefings in Bioinformatics, 22(6). https://doi.org/10.1093/bib/bbab347
Noguchi, Yoshihiro, et al. "Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source." Briefings in Bioinformatics, vol. 22, no. 6, 2021, https://doi.org/10.1093/bib/bbab347.
Noguchi, Yoshihiro, Tomoya Tachi, and Hitomi Teramachi. "Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source." Briefings in Bioinformatics 22, no. 6 (2021). https://doi.org/10.1093/bib/bbab347.
Noguchi Y., Tachi T., Teramachi H. Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source // Briefings in Bioinformatics. — 2021. — Vol. 22, № 6. — URL: https://doi.org/10.1093/bib/bbab347
@article{noguchi2021detection,
title = {{Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source}},
author = {Yoshihiro Noguchi and Tomoya Tachi and Hitomi Teramachi},
journal = {Briefings in Bioinformatics},
year = {2021},
volume = {22},
number = {6},
doi = {10.1093/bib/bbab347},
url = {https://doi.org/10.1093/bib/bbab347}
}TY - JOUR AU - Noguchi, Yoshihiro AU - Tachi, Tomoya AU - Teramachi, Hitomi TI - Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source JO - Briefings in Bioinformatics VL - 22 IS - 6 PY - 2021 DA - 2021/08/10 DO - 10.1093/bib/bbab347 UR - https://doi.org/10.1093/bib/bbab347 ER -
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