Background Randomised controlled trials (RCT) provide data on short-term, clinically measurable outcomes (safety and efficacy). Longer-term data requires extended follow-up. Post-RCT extension clinical data reporting holds challenges with no guidelines on optimal reporting1.
Objectives To produce evidence- and consensus-based recommendations on key aspects of reporting of trial extension studies (TES), applying EULAR standard operating procedures; and thereby, develop a standardised format for future TES data reporting.
Methods A taskforce of 21 (experts in RCTs, epidemiologists and patient representation) was formed. An initial meeting agreed the objectives and key areas for evaluation and formed the basis for a first Delphi survey (“0-10” level of agreement scale for given definitions). A second Delphi was undertaken; cut-off for accepting consensus was a mean score of 7/10 and rejected if more than 4 responses under 5 recorded.
Results 16/21 completed the first Delphi and 20/21 the second survey. Of a total of 26 domains, consensus has been reached on 23 domains. A flowchart detailing progress of patients from start of placebo/active comparator RCT to TES completion (including numbers withdrawing early, switching to experimental/standard of care and subsequent progress) has been designed. Eight key domains with strong consensus are summarised below. Final review and voting will be undertaken shortly.
Conclusions Strong consensus on majority of core elements of TES reporting has been reached. The final document will provide much needed recommendations to ensure a transparent and standardised approach to the reporting of TES.
Buch MH, et al. Ann Rheum Dis 2011; 70(6):886-90
Disclosure of Interest None Declared
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