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

Dixon, William G.; Carmona, Loreto; Finckh, Axel; Hetland, Merete Lund; Kvien, Tore K.; Landewe, Robert; Listing, Joachim; Nicola, Paulo J.; Tarp, Ulrik; Zink, Angela; Askling, Johan

doi:10.1136/ard.2009.125526

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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 Finckh, Axel Hetland, Merete Lund Kvien, Tore K. Landewe, Robert Listing, Joachim Nicola, Paulo J. Tarp, Ulrik Zink, Angela Askling, Johan show all authors [1 - 11]
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 & administration — Antirheumatic Agents/adverse effects/therapeutic use — Biological Agents/adverse effects/therapeutic use — Epidemiologic Methods — Europe — Humans — Patient Selection — Registries/standards — Rheumatic Diseases/*drug therapy — Treatment Outcome
Identifiers		DOI: 10.1136/ard.2009.125526 PMID: 20525843
Full text		Article - Limited access to UNIGE Other version: http://ard.bmj.com/content/69/9/1596.full.pdf
Structures		Faculté de médecine / Section de médecine clinique / Département de médecine
Research group		Mécanisme de l'inflammation articulaire (44)
Citation (ISO format)		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. doi: 10.1136/ard.2009.125526 https://archive-ouverte.unige.ch/unige:20903