RT Journal Article
SR Electronic
T1 EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 477
OP 483
DO 10.1136/ard.2007.083030
VO 68
IS 4
A1 G K Bertsias
A1 J P A Ioannidis
A1 J Boletis
A1 S Bombardieri
A1 R Cervera
A1 C Dostal
A1 J Font
A1 I M Gilboe
A1 F Houssiau
A1 T Huizinga
A1 D Isenberg
A1 C G M Kallenberg
A1 M Khamashta
A1 J C Piette
A1 M Schneider
A1 J Smolen
A1 G Sturfelt
A1 A Tincani
A1 R van Vollenhoven
A1 D T Boumpas
A1 C Gordon
YR 2009
UL http://ard.bmj.com/content/68/4/477.abstract
AB 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.