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Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

Publication ,  Journal Article
Seifert, HA; Malik, RE; Bhattacharya, M; Campbell, KR; Okun, S; Pierce, C; Terkowitz, J; Turner, JR; Krucoff, MW; Powell, GE
Published in: Am Heart J
December 2017

This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2017

Volume

194

Start / End Page

107 / 115

Location

United States

Related Subject Headings

  • Humans
  • Heart
  • Endpoint Determination
  • Drug Monitoring
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • Cardiovascular Agents
  • Biomedical Research
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Seifert, H. A., Malik, R. E., Bhattacharya, M., Campbell, K. R., Okun, S., Pierce, C., … Powell, G. E. (2017). Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank. Am Heart J, 194, 107–115. https://doi.org/10.1016/j.ahj.2017.08.021
Seifert, Harry A., Raleigh E. Malik, Mondira Bhattacharya, Kevin R. Campbell, Sally Okun, Carrie Pierce, Jeffrey Terkowitz, J Rick Turner, Mitchell W. Krucoff, and Gregory E. Powell. “Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.Am Heart J 194 (December 2017): 107–15. https://doi.org/10.1016/j.ahj.2017.08.021.
Seifert HA, Malik RE, Bhattacharya M, Campbell KR, Okun S, Pierce C, et al. Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank. Am Heart J. 2017 Dec;194:107–15.
Seifert, Harry A., et al. “Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.Am Heart J, vol. 194, Dec. 2017, pp. 107–15. Pubmed, doi:10.1016/j.ahj.2017.08.021.
Seifert HA, Malik RE, Bhattacharya M, Campbell KR, Okun S, Pierce C, Terkowitz J, Turner JR, Krucoff MW, Powell GE. Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank. Am Heart J. 2017 Dec;194:107–115.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2017

Volume

194

Start / End Page

107 / 115

Location

United States

Related Subject Headings

  • Humans
  • Heart
  • Endpoint Determination
  • Drug Monitoring
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • Cardiovascular Agents
  • Biomedical Research
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services