Table 5 Trial stopping point and requirements
From: A gated group sequential design for seamless Phase II/III trial with subpopulation selection
Stopping point | GSD | AD/gGSD |
|---|---|---|
Futility | – | Both sub-group and full group do not pass the futility boundary |
IA1 | All the 4 hypotheses are rejected at IA1 | (1) At least one group passes the futility boundary. (2) All the hypotheses tested are rejected at IA1 |
IA2 | (1) At least 1 hypothesis is not rejected at IA1. (2) All the 4 hypotheses are rejected at IA2 | (1) At least one group passes the futility boundary. (2) At least 1 hypothesis is not rejected at IA1. (3) All the hypotheses tested are rejected at IA2 |
FA | (1) At least 1 hypothesis is not rejected at IA1 and IA2. (2) The trial stops at FA regardless of the number of hypotheses rejected | (1) At least one group passes the futility boundary. (2) At least 1 hypothesis is not rejected at IA1 and IA2. (3) The trial stops at FA regardless of the number of hypotheses rejected |