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Artificial Intelligence, Real-World Automation and the Safety of Medicines

Author

Listed:
  • Andrew Bate

    (GSK
    London School of Hygiene and Tropical Medicine)

  • Steve F. Hobbiger

    (GSK)

Abstract

Despite huge technological advances in the capabilities to capture, store, link and analyse data electronically, there has been some but limited impact on routine pharmacovigilance. We discuss emerging research in the use of artificial intelligence, machine learning and automation across the pharmacovigilance lifecycle including pre-licensure. Reasons are provided on why adoption is challenging and we also provide a perspective on changes needed to accelerate adoption, and thereby improve patient safety. Last, we make clear that while technologies could be superimposed on existing pharmacovigilance processes for incremental improvements, these great societal advances in data and technology also provide us with a timely opportunity to reconsider everything we do in pharmacovigilance operations to maximise the benefit of these advances.

Suggested Citation

  • Andrew Bate & Steve F. Hobbiger, 2021. "Artificial Intelligence, Real-World Automation and the Safety of Medicines," Drug Safety, Springer, vol. 44(2), pages 125-132, February.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:2:d:10.1007_s40264-020-01001-7
    DOI: 10.1007/s40264-020-01001-7
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    References listed on IDEAS

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    1. Shirley V. Wang & Olga V. Patterson & Joshua J. Gagne & Jeffrey S. Brown & Robert Ball & Pall Jonsson & Adam Wright & Li Zhou & Wim Goettsch & Andrew Bate, 2019. "Transparent Reporting on Research Using Unstructured Electronic Health Record Data to Generate ‘Real World’ Evidence of Comparative Effectiveness and Safety," Drug Safety, Springer, vol. 42(11), pages 1297-1309, November.
    2. Shaun Comfort & Sujan Perera & Zoe Hudson & Darren Dorrell & Shawman Meireis & Meenakshi Nagarajan & Cartic Ramakrishnan & Jennifer Fine, 2018. "Sorting Through the Safety Data Haystack: Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media," Drug Safety, Springer, vol. 41(6), pages 579-590, June.
    3. John Stekelenborg & Johan Ellenius & Simon Maskell & Tomas Bergvall & Ola Caster & Nabarun Dasgupta & Juergen Dietrich & Sara Gama & David Lewis & Victoria Newbould & Sabine Brosch & Carrie E. Pierce , 2019. "Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR," Drug Safety, Springer, vol. 42(12), pages 1393-1407, December.
    4. Rebecca E. Chandler & Kristina Juhlin & Jonas Fransson & Ola Caster & I. Ralph Edwards & G. Niklas Norén, 2017. "Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®," Drug Safety, Springer, vol. 40(1), pages 81-90, January.
    5. Karolina Danysz & Salvatore Cicirello & Edward Mingle & Bruno Assuncao & Niki Tetarenko & Ruta Mockute & Danielle Abatemarco & Mark Widdowson & Sameen Desai, 2019. "Artificial Intelligence and the Future of the Drug Safety Professional," Drug Safety, Springer, vol. 42(4), pages 491-497, April.
    6. Ramani Routray & Niki Tetarenko & Claire Abu-Assal & Ruta Mockute & Bruno Assuncao & Hanqing Chen & Shenghua Bao & Karolina Danysz & Sameen Desai & Salvatore Cicirello & Van Willis & Sharon Hensley Al, 2020. "Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination," Drug Safety, Springer, vol. 43(1), pages 57-66, January.
    7. Ed Whalen & Manfred Hauben & Andrew Bate, 2018. "Time Series Disturbance Detection for Hypothesis-Free Signal Detection in Longitudinal Observational Databases," Drug Safety, Springer, vol. 41(6), pages 565-577, June.
    8. Thomas A Lasko & Joshua C Denny & Mia A Levy, 2013. "Computational Phenotype Discovery Using Unsupervised Feature Learning over Noisy, Sparse, and Irregular Clinical Data," PLOS ONE, Public Library of Science, vol. 8(6), pages 1-13, June.
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