Evaluating medicines: Let's use all the evidence

Chris W. Kelman*, Sallie Anne Pearson, Richard O. Day, C. D.Arcy J. Holman, Erich V. Kliewer, David A. Henry

*Corresponding author for this work

    Research output: Contribution to journalReview articlepeer-review

    34 Citations (Scopus)

    Abstract

    • The current drug regulatory system is outdated and relies primarily on a process of premarketing evaluation, followed by periodic reviews of reported adverse events. • While long-term medicine use for chronic conditions is now commonplace, current drug evaluation systems do not incorporate the comprehensive evidence accruing over time in clinical practice. Good quality, routinely collected data on medicines use are now available in some countries. • Consistent with international opinion, we propose an expanded and integrated system of medicines regulation for Australia, based on a surveillance system that improves safety monitoring by complementing existing systems, making best use of routinely collected data, and leveraging the power of information technology. • Australia is well placed to pilot such a model system.

    Original languageEnglish
    Pages (from-to)249-252
    Number of pages4
    JournalMedical Journal of Australia
    Volume186
    Issue number5
    DOIs
    Publication statusPublished - 5 Mar 2007

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