Epidemiological surveillance of drug safety using cumulative sequential analysis in electronic healthcare data

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Background: Methods for safety signal detection in electronic healthcare data analysing data sequentially are being developed to meet the limitations of spontaneous reporting systems. Objectives: This study aims to provide an overview of the literature on sequential analysis of electronic healthcare data and describe the development and testing of a novel epidemiological surveillance system. Methods: We searched Medline, Embase, PubMed, Scopus, Web of Science, and the Cochrane Library applying similar in- and exclusion criteria as those of a previous systematic review. The proposed system consisted of repeated cohort studies and was tested in an emulated prospective setting. Two signal evaluations were performed with several sensitivity analyses and a target trial emulation. Findings: In the literature, 11 studies analysed the data sequentially of which two applied traditional epidemiological methods. Epidemiological surveillance of several exposures and outcomes can be successfully conducted with the newly proposed sequential analysis of electronic healthcare data. Signal evaluation studies confirmed the results of the system. Conclusions: Very few studies in the literature analysed data at multiple time points, although this seems to be a prerequisite for testing the methods in a realistic setting. We demonstrated the feasibility of a sequential surveillance system using electronic healthcare data.

TidsskriftBasic and Clinical Pharmacology and Toxicology
Udgave nummer1
Sider (fra-til)129-140
StatusUdgivet - 2024

Bibliografisk note

Funding Information:
M.L.D.B. is employed by Utrecht University to conduct research under the umbrella of the Utrecht Centre for Pharmaceutical Policy and Regulation. This centre receives no direct funding or donations from private parties, including the pharma industry. Research funding from public–private partnerships (e.g., IMI, The Escher Project; http://escher.lygature.org/ ) is accepted under the condition that no company‐specific study is conducted. The centre has received unrestricted research funding from public sources (e.g., World Health Organization, Netherlands Organization for Health Research and Development, the Dutch National Health Care Institute, EC Horizon 2020, the Dutch Medicines Evaluation Board, and the Dutch Ministry of Health). M.An. has participated in research projects funded by AstraZeneca, H. Lundbeck & Mertz, Novartis, and Pfizer, and has received fees for leading courses and teaching from Atrium, the Danish. Association of the Pharmaceutical Industry. M.A. declared no competing interests for this work.

Funding Information:
This study was partly funded by a grant from the Novo Nordisk Foundation (NNF15SA0018404) to the University of Copenhagen.

Publisher Copyright:
© 2023 The Authors. Basic & Clinical Pharmacology & Toxicology published by John Wiley & Sons Ltd on behalf of Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

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