Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005–2013

Pharmacoepidemiology and Drug Safety

Volumn 26, Issue 12, 2017, Pages 1442-1450

  Bouvy, Jacoline C ^a,b   Blake, Kevin ^a   Slattery, Jim ^a   De Bruin, Marie L ^b,c   Arlett, Peter ^a   Kurz, Xavier ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b UTRECHT UNIVERSITY   (Netherlands)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

European Medicines Agency; observational research; post marketing surveillance; registries; regulatory science

Indexed keywords

AMIFAMPRIDINE; BRENTUXIMAB VEDOTIN; CANAKINUMAB; CHOLIC ACID; CLOFARABINE; COMPLEMENT COMPONENT C1S INHIBITOR; DEFERASIROX; GALSULFASE; IDURONATE 2 SULFATASE; INFLUENZA VACCINE; IVACAFTOR; LENALIDOMIDE; LOMITAPIDE; PEGLOTICASE; PIRFENIDONE; POMALIDOMIDE; RALTEGRAVIR; RECOMBINANT ANTITHROMBIN III; RECOMBINANT OSTEOGENIC PROTEIN 1; RECOMBINANT SOMATOMEDIN C; REGENERON; RILONACEPT; RUFINAMIDE; SIPULEUCEL T; SITAXSENTAN; TAFAMIDIS; TEDUGLUTIDE; TELAVANCIN; TOCOFERSOLAN;

ARTICLE; CONTROLLED STUDY; DISEASE REGISTRY; DRUG INFORMATION; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; EUROPEAN MEDICINES AGENCY; FOLLOW UP; FRANCE; GERMANY; HUMAN; INFORMATION PROCESSING; ITALY; MAJOR CLINICAL STUDY; PERSONAL EXPERIENCE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; ADVERSE DRUG REACTION; DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; EUROPE; EUROPEAN UNION; FACTUAL DATABASE; POSTMARKETING SURVEILLANCE; PROCEDURES; REGISTER;

DATABASES, FACTUAL; DRUG APPROVAL; DRUG INDUSTRY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; PHARMACOVIGILANCE; PRODUCT SURVEILLANCE, POSTMARKETING; REGISTRIES; RETROSPECTIVE STUDIES;

EID: 85016417200     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.4196     Document Type: Article

References (19)

1. Blake KV, Prilla S, Accadebled S, et al. European Medicines Agency review of post-authorisation studies with implications for the European network of centres for pharmacoepidemiology and pharmacovigilance. Pharmacoepidemiol Drug Saf 2011; 20(10): 1021–1029.
2. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2010_1235/reg_2010_1235_en.pdf (accessed 7 February 2017).
3. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf (accessed 7 February 2017).
4. PARENT Joint Action. Methodological Guidelines and Recommendations for Efficient and Rational Governance of Patient Registries, 2015. http://patientregistries.eu/deliverables (accessed 7 February 2017).
5. Agency for Healthcare Research and Quality. Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition. http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=1897 (accessed 7 February 2017).
6. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Guide on Methodological Standards in Pharmacoepidemiology. Rev. 5, 2016. http://www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml (accessed 7 February 2017).
7. European Medicines Agency. Good pharmacovigilance practices. Module VIII. Post-authorisation safety studies, Rev. 2, 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf (accessed 7 February 2017).
8. Emilsson L, Lindhal B, Köster M, Lambe M, Ludvigsson JF. Review of 103 Swedish Healthcare Quality Registries. J Intern Med 2015; 277(1): 94–136.
9. European Medicines Agency 2015. Patient Registries. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000658.jsp&mid=WC0b01ac0580961211 (accessed 7 February 2017).
10. Arkema EV, Neovius M, Joelsson JK, Simard JF, van Vollenhoven RF. Is there a sex bias in prescribing anti-tumour necrosis factor medications to patients with rheumatoid arthritis? A nation-wide cross-sectional study. Ann Rheum Dis 2012; 71(7): 1203–1206.
11. Meissner Y, Zink A, Kekow J, et al. Impact of disease activity and treatment of comorbidities on the risk of myocardial infarction in rheumatoid arthritis. Arthritis Res Ther 2016; 18(1): 183.
12. Courvoisier DS, Alpizar-Rodriguez D, Gottenberg JE, et al. Rheumatoid arthritis patients after initiation of a new biologic agent: trajectories of disease activity in a large multinational cohort study. EBioMedicine 2016 Sep; 11: 302–306.
13. Mercer LK, Galloway JB, Lunt M, et al. Risk of lymphoma in patients exposed to antitumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Ann Rheum Dis 2017; 76(3): 497–503.
14. Gerhold K, Richter A, Schneider M, et al. Health-related quality of life in patients with long-standing rheumatoid arthritis in the era of biologics: data from the German biologics register RABBIT. Rheumatology 2015; 54(10): 1858–1866.
15. Olofsson T, Petersson IF, Eriksson JK, et al. Predictors of work disability during the first 3 years after diagnosis in a national rheumatoid arthritis inception cohort. Ann Rheum Dis 2014; 73(5): 845–853.
16. Bloom S. Registries in chronic disease: coming your way soon? Rheumatology (Oxford) 2011; 50(1): 4–5.
17. Krumholz HM. Registries and selection bias: the need for accountability. Circ Cardiovasc Qual Outcomes 2009; 2: 517–518.
18. Fereirra-Gonzalez I, Marsal JR, Mitjavila F, et al. Patient registries of acute coronary syndrome. Assessing or biasing the clinical real world data? Circ Cardiovasc Qual Outcomes 2009; 2: 540–547.
19. Eichler HG, Baird LG, Bloechl-Daum B, et al. From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin Pharmacol Ther 2015; 97(3): 234–246.