Digital biomarkers for post-licensure safety monitoring. Issue 11 (November 2022)

• Record Type: Journal Article
• Authors: Garcia-Gancedo, Luis; Bate, Andrew
• Is Part Of: Drug discovery today. Volume 27:Issue 11(2022)
• Publication Date: 2022-11
• Subjects: Digital health tools -- Digital biomarkers -- Safety -- Pharmacovigilance; Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2022.103354
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: Post-licensure safety data are paramount for the safe use of medicines. Capturing richer data would facilitate earlier and more-reliable safety insights. Digital personal health-related data are often collected but not necessarily used in safety evaluation. Broader use of these data could facilitate approaches to the safety assessment of medicines. 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.