Table 2.
Summary of design features for SHINE and the Goldilocks alternative
| 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 |