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

Detalhes bibliográficos
Autor(a) principal: Dixon, William G.
Data de Publicação: 2010
Outros Autores: Carmona, Loreto, Finckh, Axel, Hetland, Merete Lund, Kvien, Tore K., Landewe, Robert, Listing, Joachim, Nicola, Paulo J., Tarp, Ulrik, Zink, Angela, Askling, Johan
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10451/17637
Resumo: Copyright © 2010 BMJ Publishing Group Ltd & European League Against Rheumatism. All rights reserved
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spelling EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatologyCopyright © 2010 BMJ Publishing Group Ltd & European League Against Rheumatism. All rights reservedOBJECTIVES: 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.BMJ Publishing GroupRepositório da Universidade de LisboaDixon, William G.Carmona, LoretoFinckh, AxelHetland, Merete LundKvien, Tore K.Landewe, RobertListing, JoachimNicola, Paulo J.Tarp, UlrikZink, AngelaAskling, Johan2015-03-09T11:44:00Z20102010-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/17637engAnn Rheum Dis 2010 69: 1596-16020003-4967http://dx.doi.org/10.1136/ard.2009.125526metadata only accessinfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:03:23Zoai:repositorio.ul.pt:10451/17637Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:37:27.510591Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
title EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
spellingShingle EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
Dixon, William G.
title_short EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
title_full EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
title_fullStr EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
title_full_unstemmed EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
title_sort EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology
author Dixon, William G.
author_facet 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
author_role author
author2 Carmona, Loreto
Finckh, Axel
Hetland, Merete Lund
Kvien, Tore K.
Landewe, Robert
Listing, Joachim
Nicola, Paulo J.
Tarp, Ulrik
Zink, Angela
Askling, Johan
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv 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
description Copyright © 2010 BMJ Publishing Group Ltd & European League Against Rheumatism. All rights reserved
publishDate 2010
dc.date.none.fl_str_mv 2010
2010-01-01T00:00:00Z
2015-03-09T11:44:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10451/17637
url http://hdl.handle.net/10451/17637
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Ann Rheum Dis 2010 69: 1596-1602
0003-4967
http://dx.doi.org/10.1136/ard.2009.125526
dc.rights.driver.fl_str_mv metadata only access
info:eu-repo/semantics/openAccess
rights_invalid_str_mv metadata only access
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
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