From big data to bedside decision-making: the case for AdverseEvents

  • Giuseppe Biondi Zoccai | gbiondizoccai@gmail.com Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
  • Elena Cavarretta Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
  • Giacomo Frati Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.

Abstract

Evidence-based medicine has gained mainstream popularity, but it requires a delicate balance between clinical evidence, physician skills, patient preferences, and costs. Facing the individual patient, even a simple decision such as which antithrombotic agent should be prescribed becomes complex. There are several reasons for this conundrum, but one of the foremost is the limited external validity of pivotal randomized trials, with their extremely restrictive selection criteria. Post-marketing reporting of adverse events is a very useful and democratic means to appraise the risk-benefit profile, but to date such reports were not organized or available. The development of the Food and Drug Administration (FDA) venue for such task, the FDA Adverse Event Reporting System (FAERS) has substantially improved data collection. However, analysis of this extensive relational database remains complex for most but few companies or agencies. AdverseEvents is a novel online platform enabling updated and user-friendly inquiry of FAERS. Given its ease of use, flexibility and comprehensiveness, it is likely going to improve decision making for healthcare authorities and practitioners, as well as patients. This is clearly testified by the precise and informative comparative analysis that can be performed with AdverseEvents on novel antithrombotic agents.

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Published
2013-07-01
Info
Issue
Section
Editorials
Keywords:
AdverseEvents, anticoagulant therapy, antiplatelet therapy, antithrombotic therapy
Statistics
  • Abstract views: 3503

  • PDF: 514
How to Cite
Biondi Zoccai, G., Cavarretta, E., & Frati, G. (2013). From big data to bedside decision-making: the case for AdverseEvents. Drugs and Therapy Studies, 3(1), e3. https://doi.org/10.4081/dts.2013.e3