Table 2 Summary of design features for SHINE and the Goldilocks alternative
From: The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study
SHINE | Goldilocks | |
|---|---|---|
Hypothesis testing | Two-sided | One sided |
Primary analysis | Covariate adjusted | Unadjusted |
Randomization | Response adaptive | 1:1 |
Minimum sample size | Approx 600 | Fixed at 500 |
Maximum sample size | Between 1,400 and 1,718 | Fixed at 1,400 |
Planned interim analyses | 4 | 9 |
Stopping boundaries | Group sequential | Predictive probabilities, incorporating early information |
Complete follow-up of all patients in event of early termination | Undefined critical value | Explicitly defined critical value |