Cost-benefit of outcome adjudication in nine randomised stroke trials

Clin Trials. 2020 Oct;17(5):576-580. doi: 10.1177/1740774520939231. Epub 2020 Jul 10.

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Keywords: Adjudication; clinical trial; stroke.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cost-Benefit Analysis*
  • Humans
  • Judgment
  • Outcome Assessment, Health Care / economics*
  • Outcome Assessment, Health Care / methods
  • Randomized Controlled Trials as Topic / economics*
  • Randomized Controlled Trials as Topic / methods
  • Stroke / therapy*
  • Treatment Outcome