Abstract
Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process. We estimated the cost of adjudicating the primary outcome in nine randomised stroke trials (25,436 participants). The costs included adjudicators' time, direct payments to adjudicators, and co-ordinating centre costs (e.g. uploading cranial scans and general set-up costs). The number of events corrected after adjudication was our measure of benefit. We calculated cost per corrected event for each trial and in total. The primary outcome in all nine trials was either stroke or a composite that included stroke. In total, the adjudication process associated with this primary outcome cost in excess of £100,000 for a third of the trials (3/9). Mean cost per event corrected by adjudication was £2295.10 (SD: £1482.42). Central adjudication is a time-consuming and potentially costly process. These costs need to be considered when designing a trial and should be evaluated alongside the potential benefits adjudication brings to determine whether they outweigh this expense.
Highlights
In randomised stroke trials, central adjudication of outcomes is common[1]
This measure does not take into account whether the adjudication process impacts on the treatment effect estimate
(7/9, 77%) adjudicators reviewed only those events identified by the site investigators, but for two of the studies adjudicators assessed a larger number of events, by adjudicating either suspected events or all participants (See Supplementary Material, Supplementary Table I).The time taken per adjudication range from five minutes to two hours
Summary
Central adjudication of outcomes is common[1]. Adjudicators are typically blinded independent experts who review individual participant data and provide an assessment of outcome(s). Central adjudication should reduce both random and systematic bias, but studies have shown that it has limited impact on the estimated treatment effect in randomised trials[1,2,3]. The cost of adjudication could be estimated as the direct cost paid to the adjudicator, which is often a menial amount (£10-15 per adjudication) This does not take into account the time it takes the adjudicator to undertake their assessment of the individual participant data. Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. Few studies have estimated the cost of the adjudication process
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