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EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
  1. William G Dixon1,
  2. Loreto Carmona2,
  3. Axel Finckh3,
  4. Merete Lund Hetland4,
  5. Tore K Kvien5,
  6. Robert Landewe6,
  7. Joachim Listing7,
  8. Paulo J Nicola8,
  9. Ulrik Tarp9,
  10. Angela Zink7,
  11. Johan Askling10
  1. 1Arthritis Research UK Epidemiology Unit, The University of Manchester, Manchester, UK
  2. 2Research Unit, Fundación Española de Reumatología, Madrid, Spain
  3. 3SCQM Foundation, Geneva University Hospital, Geneva, Switzerland
  4. 4DANBIO, Department of Rheumatology, Hvidovre and Glostrup Hospitals, University of Copenhagen, Copenhagen, Denmark
  5. 5Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  6. 6Maastricht University Medical Center, Maastricht, The Netherlands
  7. 7Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany
  8. 8Epidemiology Unit, Institute for Preventive Medicine, University of Lisbon Medical School, Lisbon, Portugal
  9. 9Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
  10. 10Department of Rheumatology, Karolinska University Hospital and Institute, Stockholm, Sweden
  1. Correspondence to William G Dixon, Arthritis Research UK Epidemiology Unit, The University of Manchester, Stopford Building, Oxford Road, Manchester M13 9PT, UK; will.dixon{at}manchester.ac.uk

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.

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Footnotes

  • Competing interests None. Johannes WJ Bijlsma was the handling editor for this manuscript.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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