Digital biomarkers for post-licensure safety monitoring

Luis Garcia-Gancedo; Andrew Bate

doi:10.1016/j.drudis.2022.103354

Digital biomarkers for post-licensure safety monitoring

Drug Discov Today. 2022 Nov;27(11):103354. doi: 10.1016/j.drudis.2022.103354. Epub 2022 Sep 13.

Authors

Luis Garcia-Gancedo¹, Andrew Bate²

Affiliations

¹ Value Evidence and Outcomes (VEO), GSK, Stevenage, UK.
² Global Safety, GSK, Brentford, UK; Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; Department of Medicine, NYU Grossman School of Medicine, New York, NY, USA.

PMID: 36108916
DOI: 10.1016/j.drudis.2022.103354

Abstract

Post-licensure safety data form the cornerstone of safety surveillance. However, such data have some limitations related to the subjectiveness of reporting and recording, primary purpose of the collected data, or heterogeneity. Routine capture of richer data would in part help mitigate these limitations, enabling earlier, more reliable safety insights. Digital health tools that remotely acquire health-related information are increasingly available and used by patients and the wider population. However, they are rarely used for pharmacovigilance purposes. Here, we review different cases that reveal the opportunities and challenges of using these technologies for enhanced safety assessment in routine healthcare delivery. We believe such approaches will advance our understanding of the safety of drugs and vaccines in the future.

Keywords: Digital biomarkers; Digital health tools; Pharmacovigilance; Safety.