Table 1 Example interpretations of outcomes for phase II futility trial
From: Interpreting a Bayesian phase II futility clinical trial
| Â | Phase II futility | Phase II efficacy |
|---|---|---|
Fail to reject \(H_0\) | The data do not rule out superiority of the new treatment relative to control. | There is not sufficient evidence that the treatment is efficacious relative to control and therefore does not warrant additional review. |
Reject \(H_0\) | There is sufficient evidence that the benefit of the treatment is less than desired and it is futile to proceed to phase III. | The treatment demonstrates a signal of improvement relative to control and therefore warrants additional study. |