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.

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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.

1. Buch MH, et al. Ann Rheum Dis 2011; 70(6):886-90

Disclosure of Interest None Declared