Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making

Didrik Wessel () and Nicolai Pogrebnyakov
Additional contact information
Didrik Wessel: Copenhagen Business School
Nicolai Pogrebnyakov: Copenhagen Business School

Drug Safety, 2024, vol. 47, issue 5, No 8, 495-511

Abstract: Abstract Introduction While pharmaceutical companies aim to leverage real-world data (RWD) to bridge the gap between clinical drug development and real-world patient outcomes, extant research has mainly focused on the use of social media in a post-approval safety-surveillance setting. Recent regulatory and technological developments indicate that social media may serve as a rich source to expand the evidence base to pre-approval and drug development activities. However, use cases related to drug development have been largely omitted, thereby missing some of the benefits of RWD. In addition, an applied end-to-end understanding of RWD rooted in both industry and regulations is lacking. Objective We aimed to investigate how social media can be used as a source of RWD to support regulatory decision making and drug development in the pharmaceutical industry. We aimed to specifically explore the data pipeline and examine how social-media derived RWD can align with regulatory guidance from the US Food and Drug Administration and industry needs. Methods A machine learning pipeline was developed to extract patient insights related to anticoagulants from X (Twitter) data. These findings were then analysed from an industry perspective, and complemented by interviews with professionals from a pharmaceutical company. Results The analysis reveals several use cases where RWD derived from social media can be beneficial, particularly in generating hypotheses around patient and therapeutic area needs. We also note certain limitations of social media data, particularly around inferring causality. Conclusions Social media display considerable potential as a source of RWD for guiding efforts in pharmaceutical drug development and pre-approval settings. Although further regulatory guidance on the use of social media for RWD is needed to encourage its use, regulatory and technological developments are suggested to warrant at least exploratory uses for drug development.

Date: 2024
References: View references in EconPapers View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-024-01409-5 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:47:y:2024:i:5:d:10.1007_s40264-024-01409-5

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

DOI: 10.1007/s40264-024-01409-5

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 ().