EULAR points to consider for conducting clinical trials in systemic lupus erythematosus
(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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https://lup.lub.lu.se/record/1405049
- author
- organization
- publishing date
- 2009
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Annals of the Rheumatic Diseases
- volume
- 68
- issue
- 4
- pages
- 470 - 476
- publisher
- BMJ Publishing Group
- external identifiers
-
- wos:000264196000004
- scopus:65249174511
- pmid:18388158
- 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
- 2016-04-01 14:19:38
- date last changed
- 2022-02-04 20:19:57
@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 = {{BMJ Publishing Group}}, 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}}, doi = {{10.1136/ard.2007.083022}}, volume = {{68}}, year = {{2009}}, }