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Title

EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology

Authors
Dixon, William G.
Carmona, Loreto
Hetland, Merete Lund
Kvien, Tore K.
Landewe, Robert
Listing, Joachim
Nicola, Paulo J.
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Published in Annals of the Rheumatic Diseases. 2010, vol. 69, no. 9, p. 1596-1602
Abstract OBJECTIVES: The introduction of biological therapies for the treatment of rheumatic diseases has drawn attention to the limitations of traditional means of assessing drug safety. Consequently, a series of European academic biologics registers dedicated to this task have been established. Increasing reliance upon safety data generated from observational drug registers makes it important to convert the lessons learned from such registers into recommendations for rheumatologists embarking upon the establishment of future registers, or analysing and reporting from new and existing registers. METHODS: The Task Force encompassed 11 scientists from European Rheumatology drug registers. Through an informal inventory of critical elements in the establishment of existing rheumatoid arthritis drug registers, of analytical strategies used and of limitations of their results, several 'points to consider'--beyond established generic guidelines for observational registers/studies but with particular relevance to biologics registers on safety in rheumatology--were assembled. For each 'point to consider', contextual and methodological background and examples were compiled. RESULTS: A set of seven points to consider was assembled for the establishment of new drug registers with a focus on purpose, population to be targeted, data collection, handling and storage as well as ethical and legal considerations. For analysis and reporting, nine points to consider were assembled (setting, participant, variable, statistical method, descriptive data, outcome data, main results, other analyses and limitations). CONCLUSIONS: Thoughtful design and planning before the establishment of biologics registers will increase their sustainability, versatility and raw data quality. Harmonisation of analyses and reporting from such registers will improve interpretation of drug safety studies.
Keywords Adverse Drug Reaction Reporting Systems/*organization & administrationAntirheumatic Agents/*adverse effects/therapeutic useBiological Agents/*adverse effects/therapeutic useEpidemiologic MethodsEuropeHumansPatient SelectionRegistries/*standardsRheumatic Diseases/*drug therapyTreatment Outcome
Identifiers
PMID: 20525843
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Other version: http://ard.bmj.com/content/69/9/1596.full.pdf
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Research group Mécanisme de l'inflammation articulaire (44)
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DIXON, William G. et al. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. In: Annals of the Rheumatic Diseases, 2010, vol. 69, n° 9, p. 1596-1602. https://archive-ouverte.unige.ch/unige:20903

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Deposited on : 2012-05-23

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