TY - JOUR T1 - Why we need guidelines for clinical trials in vasculitis and systemic lupus erythematosus JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 569 LP - 570 DO - 10.1136/ard.2006.065854 VL - 66 IS - 5 AU - Chetan Mukhtyar AU - Dimitrios Boumpas AU - Caroline Gordon AU - Wolfgang Gross AU - David Jayne AU - Raashid Luqmani Y1 - 2007/05/01 UR - http://ard.bmj.com/content/66/5/569.abstract N2 - See linked article, p 605The systemic vasculitides and systemic lupus erythematosus (SLE) are uncommon systemic rheumatic diseases. They have attracted increasing clinical trial activity, for which there is a need for international consensus and guidelines on clinical research methodology. There have been a number of relatively small studies of these diseases. Unfortunately, these have had varying design, outcome and assessment measures, thus it is difficult to interpret the evidence or subject it to a meta-analysis, and this has resulted in considerable uncertainty—for example, in deciding the role and dosing of cyclophosphamide in vasculitis or SLE.1–,4 Standardisation of the methodology for conducting clinical trials facilitates recruitment of patients into larger multicentre studies, which are likely to include non-expert centres, because of the low incidence and prevalence of cases. There is increasing involvement by the pharmaceutical industry in clinical trials of SLE and vasculitis. These companies will also need guidelines on which to base their trial protocols. Furthermore, standardisation allows for future inter-trial comparisons and meta-analysis of separately conducted studies. The purpose of this editorial is to highlight the existence of a new set of recommendations to improve the conduct of clinical trials in vasculitis and SLE.The vasculitis and SLE working groups of the European League Against Rheumatism (EULAR) Standing … ER -