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    Health Canada's use of its priority review process for new drugs: a cohort study by Joel Lexchin

    Published 2015-05-01
    “…The purpose of this study is to compare Health Canada's use of priority reviews to therapeutic ratings from two independent organisations, the Patented Medicine Prices Review Board (PMPRB) and the French drug bulletin Prescrire International, over the period 1 January 1997–31 December 2012.Design Cohort study.Data sources Annual reports of the Therapeutic Products Directorate, and the Biologics and Genetic Therapies Directorate; evaluations of therapeutic innovation from PMPRB and Prescrire International; WHO Collaborating Centre for Drug Statistics Methodology.Interventions Assessments by PMPRB and Prescrire International treated as a gold standard for postmarket therapeutic value.Primary and secondary outcome measures Drug-by-drug comparison between the review status from Health Canada and the therapeutic status from PMPRB/Prescrire using κ values, and positive and negative predictive values. …”
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