SEARCH

SEARCH BY CITATION

References

  • 1
    Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998; 20(Suppl. C): C404.
  • 2
    Stephenson WP, Hauben M. Data mining for signals in spontaneous reporting databases: proceed with caution. Pharmacoepidemiol Drug Saf 2007; 16: 35965.
  • 3
    Molokhia M, Tanna S, Bell D. Improving reporting of adverse drug reactions: systematic review. Clin Epidemiol 2009; 1: 7592.
  • 4
    Hennessy S. Use of health care databases in pharmacoepidemiology. Basic Clin Pharmacol Toxicol 2006; 98: 31113.
  • 5
    Garcia Rodriguez LA, Perez Gutthann S. Use of the UK General Practice Research Database for pharmacoepidemiology. Br J Clin Pharmacol 1998; 45: 41925.
  • 6
    Suissa S, Garbe E. Primer: administrative health databases in observational studies of drug effects–advantages and disadvantages. Nat Clin Pract Rheumatol 2007; 3: 72532.
  • 7
    Chen RT, Glasser JW, Rhodes PH et al. Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team. Pediatrics 1997; 99: 76573.
  • 8
    Platt R, Wilson M, Chan KA, Benner JS, Marchibroda J, McClellan M. The new Sentinel Network–improving the evidence of medical-product safety. N Engl J Med 2009; 361: 6457.
  • 9
    Robb MA, Racoosin JA, Worrall C, Chapman S, Coster T, Cunningham FE. Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration. Med Care 2012; 50: 94853.
  • 10
    Platt R, Carnahan RM, Brown JS et al. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012; 21(Suppl. 1): 18.
  • 11
    Nguyen M, Ball R, Midthun K, Lieu TA. The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise. Pharmacoepidemiol Drug Saf 2012; 21(Suppl. 1): 2917.
  • 12
    Stang PE, Ryan PB, Racoosin JA et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010; 153: 6006.
  • 13
    Coloma PM, Schuemie MJ, Trifiro G et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf 2011; 20: 111.
  • 14
    Valenciano M, Ciancio B. I-MOVE: a European network to measure the effectiveness of influenza vaccines. Euro Surveill 2012; 17: 12.
  • 15
    Dieleman J, Romio S, Johansen K, Weibel D, Bonhoeffer J, Sturkenboom M. Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 2011; 343: d3908.
  • 16
    Wijnans L, Lecomte C, de Vries C et al. The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns. Vaccine 2013; 31: 124654.
  • 17
    Suissa S, Henry D, Caetano P et al. CNODES: the Canadian Network for Observational Drug Effect Studies. Open Med 2012; 6: e13440.
  • 18
    Schadt EE. The changing privacy landscape in the era of big data. Mol Syst Biol 2012; 8: 612.
  • 19
    Meyboom RH, Egberts AC, Gribnau FW, Hekster YA. Pharmacovigilance in perspective. Drug Saf 1999; 21: 42947.
  • 20
    Re-use of Mini-Sentinel data following rapid assessments of potential safety signals using customizable modular programs. Available from: http://www.mini-sentinel.org/work_products/Statistical_Methods/Mini-Sentinel_Methods_Re-use-of-Mini-Sentinel-Data.pdf.
  • 21
    VAESCO Consortium. Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigationSeptember 2012: Available from: http://www.ecdc.europa.eu/en/publications/publications/vaesco%20report%20final%20with%20cover.pdf.
  • 22
    McClellan M. Drug safety reform at the FDA–pendulum swing or systematic improvement? N Engl J Med 2007; 356: 17002.
  • 23
    Hammond IW, Gibbs TG, Seifert HA, Rich DS. Database size and power to detect safety signals in pharmacovigilance. Expert Opin Drug Saf 2007; 6: 71321.
  • 24
    Coloma PM, Trifiro G, Schuemie MJ et al. Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf 2012; 21: 61121.
  • 25
    Andrews N, Stowe J, Miller E et al. A collaborative approach to investigating the risk of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark. Vaccine 2012; 30: 30426.
  • 26
    Blake KV, Devries CS, Arlett P, Kurz X, Fitt H. Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol Drug Saf 2012; 21: 6906.
  • 27
    Sturkenboom MC, Verhamme KM, Nicolosi A et al. Drug use in children: cohort study in three European countries. BMJ 2008; 337: a2245.
  • 28
    Mini-Sentinel. Overview and Description of the Common Data Model v2.1. 2012; Available from: http://www.mini-sentinel.org/work_products/Data_Activities/Mini-Sentinel_Common-Data-Model_v2.1.pdf.
  • 29
    Overhage JM, Ryan PB, Reich CG, Hartzema AG, Stang PE. Validation of a common data model for active safety surveillance research. J Am Med Inform Assoc 2012; 19: 5460.
  • 30
    OMOP. Observational Medical Outcomes Partnership Common Data Model Specifications Version 4.0. Available from: http://omop.fnih.org/CDMvocabV4.
  • 31
    Reich C, Ryan PB, Stang PE, Rocca M. Evaluation of alternative standardized terminologies for medical conditions within a network of observational healthcare databases. J Biomed Inform 2012; 45: 68996.
  • 32
    Trifiro G, Pariente A, Coloma PM et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf 2009; 18: 117684.
  • 33
    Lindberg DA, Humphreys BL, McCray AT. The unified medical language system. Methods Inf Med 1993; 32: 28191.
  • 34
    Avillach P, Coloma PM, Gini R et al. Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project. J Am Med Inform Assoc 2013; 20: 18492.