Black Swan Events and Intelligent Automation for Routine Safety Surveillance

Oeystein Kjoersvik and Andrew Bate ()
Additional contact information
Oeystein Kjoersvik: R&D IT, MSD
Andrew Bate: Global Safety, GSK

Drug Safety, 2022, vol. 45, issue 5, No 3, 419-427

Abstract: Abstract Effective identification of previously implausible safety signals is a core component of successful pharmacovigilance. Timely, reliable, and efficient data ingestion and related processing are critical to this. The term ‘black swan events’ was coined by Taleb to describe events with three attributes: unpredictability, severe and widespread consequences, and retrospective bias. These rare events are not well understood at their emergence but are often rationalized in retrospect as predictable. Pharmacovigilance strives to rapidly respond to potential black swan events associated with medicine or vaccine use. Machine learning (ML) is increasingly being explored in data ingestion tasks. In contrast to rule-based automation approaches, ML can use historical data (i.e., ‘training data’) to effectively predict emerging data patterns and support effective data intake, processing, and organisation. At first sight, this reliance on previous data might be considered a limitation when building ML models for effective data ingestion in systems that look to focus on the identification of potential black swan events. We argue that, first, some apparent black swan events—although unexpected medically—will exhibit data attributes similar to those of other safety data and not prove algorithmically unpredictable, and, second, standard and emerging ML approaches can still be robust to such data outliers with proper awareness and consideration in ML system design and with the incorporation of specific mitigatory and support strategies. We argue that effective approaches to managing data on potential black swan events are essential for trust and outline several strategies to address data on potential black swan events during data ingestion.

Date: 2022
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
http://link.springer.com/10.1007/s40264-022-01169-0 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:45:y:2022:i:5:d:10.1007_s40264-022-01169-0

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-022-01169-0

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().