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EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints

Bertsias, G. K.; Ioannidis, J. P. A.; Boletis, J.; Bombardieri, S.; Cervera, R.; Dostal, C.; Font, J.; Gilboe, I. M.; Houssiau, F. and Huizinga, T., et al. (2009) In Annals of the Rheumatic Diseases 68(4). p.477-483
Abstract
Objective: To assess available evidence on the use of end-points ( outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE. Methods: The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design,... (More)
Objective: To assess available evidence on the use of end-points ( outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE. Methods: The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists. Results: Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken. Conclusion: This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE. (Less)
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published
subject
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Annals of the Rheumatic Diseases
volume
68
issue
4
pages
477 - 483
publisher
British Medical Association
external identifiers
  • wos:000264196000005
  • scopus:65249108137
ISSN
1468-2060
DOI
10.1136/ard.2007.083030
language
English
LU publication?
yes
id
b01a0b4e-8540-439c-bfbd-360d54997cd9 (old id 1405072)
date added to LUP
2009-06-15 09:58:37
date last changed
2017-10-29 03:46:51
@article{b01a0b4e-8540-439c-bfbd-360d54997cd9,
  abstract     = {Objective: To assess available evidence on the use of end-points ( outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE. Methods: The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists. Results: Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken. Conclusion: This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.},
  author       = {Bertsias, G. K. and Ioannidis, J. P. A. and Boletis, J. and Bombardieri, S. and Cervera, R. and Dostal, C. and Font, J. and Gilboe, I. M. and Houssiau, F. and Huizinga, T. and Isenberg, D. and Kallenberg, C. G. M. and Khamashta, M. and Piette, J. C. and Schneider, M. and Smolen, J. and Sturfelt, Gunnar and Tincani, A. and van Vollenhoven, R. and Boumpas, D. T. and Gordon, C.},
  issn         = {1468-2060},
  language     = {eng},
  number       = {4},
  pages        = {477--483},
  publisher    = {British Medical Association},
  series       = {Annals of the Rheumatic Diseases},
  title        = {EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints},
  url          = {http://dx.doi.org/10.1136/ard.2007.083030},
  volume       = {68},
  year         = {2009},
}