| アブストラクト | This study measured the exposure to different categories of medicinal products discussed by the European Union (EU) Pharmacovigilance Risk Assessment Committee from September to November 2018 in four electronic primary care health databases: IQVIA Medical Research Data-UK, IQVIA Medical Research Data-France, IQVIA Medical Research Data-Germany, and Clinical Practice Research Datalink Aurum, in the entire lifespan of each database until August 31, 2018. The assessment of 83 centrally authorized products and 45 nationally authorized products showed that coverage was better for products marketed for longer duration and worse for orphan drugs. The ability to detect associations against hypothetical comparators was better for more common events and for larger effect sizes. Coverage of advanced therapies was worse for those typically administered in a specialized rather than primary care setting. This study shows that to enable better informed regulatory decisions there is a need to access complementary data sources, particularly capturing secondary care prescribing. |
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| ジャーナル名 | Clinical pharmacology and therapeutics |
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| Pubmed追加日 | 2020/1/20 |
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| 投稿者 | Flynn, Robert; Hedenmalm, Karin; Murray-Thomas, Tarita; Pacurariu, Alexandra; Arlett, Peter; Shepherd, Hilary; Myles, Puja; Kurz, Xavier |
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| 組織名 | Pharmacovigilance and Epidemiology Department, European Medicines Agency,;Amsterdam, The Netherlands.;Medicines Monitoring Unit (MEMO), Division of Molecular and Clinical Medicine,;University of Dundee, Dundee, UK.;Clinical Practice Research Datalink (CPRD), Medicines and Healthcare Products;Regulatory Agency (MHRA), London, UK. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/31955404/ |
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