PT  - JOURNAL ARTICLE
AU  - William G Dixon
AU  - Loreto Carmona
AU  - Axel Finckh
AU  - Merete Lund Hetland
AU  - Tore K Kvien
AU  - Robert Landewe
AU  - Joachim Listing
AU  - Paulo J Nicola
AU  - Ulrik Tarp
AU  - Angela Zink
AU  - Johan Askling
TI  - EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
AID  - 10.1136/ard.2009.125526
DP  - 2010 Sep 01
TA  - Annals of the Rheumatic Diseases
PG  - 1596--1602
VI  - 69
IP  - 9
4099  - http://ard.bmj.com/content/69/9/1596.short
4100  - http://ard.bmj.com/content/69/9/1596.full
SO  - Ann Rheum Dis2010 Sep 01; 69
AB  - 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.