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EULAR points to consider for conducting clinical trials in systemic lupus erythematosus

Gordon, C.; Bertsias, G.; Ioannidis, J. P. A.; Boletis, J.; Bombardieri, S.; Cervera, R.; Dostal, C.; Font, J.; Gilboe, I-M and Houssiau, F., et al. (2009) In Annals of the Rheumatic Diseases 68(4). p.470-476
Abstract
Objective: Systemic lupus erythematosus (SLE) is a complex multi-organ disease, characterised by relapses and remissions. Designing a high-quality randomised controlled trial poses many challenges. We have developed evidenced-based recommendations for points to consider in conducting clinical trials in patients with SLE. Methods: The EULAR Task Force on SLE comprised 19 specialists and a clinical epidemiologist. Initially, the evidence for clinical trial end-points in SLE was evaluated and this has been reported separately. A consensus approach was developed by the SLE Task Force in formulating recommendations for points to consider when conducting clinical trials in SLE. Results: The literature review revealed that most outcome measures... (More)
Objective: Systemic lupus erythematosus (SLE) is a complex multi-organ disease, characterised by relapses and remissions. Designing a high-quality randomised controlled trial poses many challenges. We have developed evidenced-based recommendations for points to consider in conducting clinical trials in patients with SLE. Methods: The EULAR Task Force on SLE comprised 19 specialists and a clinical epidemiologist. Initially, the evidence for clinical trial end-points in SLE was evaluated and this has been reported separately. A consensus approach was developed by the SLE Task Force in formulating recommendations for points to consider when conducting clinical trials in SLE. Results: The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not actually been validated in clinical trials, although other forms of validation have been undertaken. The final recommendations for points to consider for conducting clinical trials in SLE address the following areas: study design, eligibility criteria, outcome measures including adverse events, concomitant therapies for SLE and its complications. Conclusions: Recommendations for points to consider when conducting clinical trials in SLE were developed using an evidence-based approach followed by expert consensus. The recommendations should be disseminated, implemented and then reviewed in detail and revised using an evidence-based approach in about 5 years, by which time there will be further evidence to consider from current clinical trials. (Less)
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Contribution to journal
publication status
published
subject
in
Annals of the Rheumatic Diseases
volume
68
issue
4
pages
470 - 476
publisher
British Medical Association
external identifiers
  • wos:000264196000004
  • scopus:65249174511
ISSN
1468-2060
DOI
10.1136/ard.2007.083022
language
English
LU publication?
yes
id
55480e09-2879-42df-8bc8-1403435b9c02 (old id 1405049)
date added to LUP
2009-06-15 09:57:47
date last changed
2017-10-01 04:20:55
@article{55480e09-2879-42df-8bc8-1403435b9c02,
  abstract     = {Objective: Systemic lupus erythematosus (SLE) is a complex multi-organ disease, characterised by relapses and remissions. Designing a high-quality randomised controlled trial poses many challenges. We have developed evidenced-based recommendations for points to consider in conducting clinical trials in patients with SLE. Methods: The EULAR Task Force on SLE comprised 19 specialists and a clinical epidemiologist. Initially, the evidence for clinical trial end-points in SLE was evaluated and this has been reported separately. A consensus approach was developed by the SLE Task Force in formulating recommendations for points to consider when conducting clinical trials in SLE. Results: The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not actually been validated in clinical trials, although other forms of validation have been undertaken. The final recommendations for points to consider for conducting clinical trials in SLE address the following areas: study design, eligibility criteria, outcome measures including adverse events, concomitant therapies for SLE and its complications. Conclusions: Recommendations for points to consider when conducting clinical trials in SLE were developed using an evidence-based approach followed by expert consensus. The recommendations should be disseminated, implemented and then reviewed in detail and revised using an evidence-based approach in about 5 years, by which time there will be further evidence to consider from current clinical trials.},
  author       = {Gordon, C. and Bertsias, G. 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. W. J. and Isenberg, D. and Kallenberg, C. G. M. and Khamashta, M. A. and Piette, J-C and Schneider, M. and Smolen, J. S. and Sturfelt, Gunnar and Tincani, A. and Van Vollenhoven, R. and Boumpas, D. T.},
  issn         = {1468-2060},
  language     = {eng},
  number       = {4},
  pages        = {470--476},
  publisher    = {British Medical Association},
  series       = {Annals of the Rheumatic Diseases},
  title        = {EULAR points to consider for conducting clinical trials in systemic lupus erythematosus},
  url          = {http://dx.doi.org/10.1136/ard.2007.083022},
  volume       = {68},
  year         = {2009},
}