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Table 4 Power for three simulation settings

From: A gated group sequential design for seamless Phase II/III trial with subpopulation selection

 

Setting 1

Setting 2

Setting 3

Weight(\({w}_{1k},{w}_{2k}\))

Design

S

S & F

S

S & F

S

PFS

OS

GSD

0.877

0.873

0.908

0.908

0.908

(\({w}_{1k}^{PFS},{w}_{2k}^{PFS}\))a

(\({w}_{1k}^{OS},{w}_{2k}^{OS}\))a

AD

0.903

0.914

0.945

0.947

0.908

gGSD

0.914

0.925

0.945

0.947

0.908

(\(\sqrt{0.2},\sqrt{0.8}\))

(\(\sqrt{0.2},\sqrt{0.8}\))

AD

0.749

0.750

0.830

0.830

0.798

gGSD

0.769

0.770

0.829

0.829

0.798

(\(\sqrt{0.3},\sqrt{0.7}\))

(\(\sqrt{0.3},\sqrt{0.7}\))

AD

0.808

0.813

0.877

0.878

0.844

gGSD

0.826

0.830

0.877

0.878

0.846

(\(\sqrt{0.5},\sqrt{0.5}\))

(\(\sqrt{0.5},\sqrt{0.5}\))

AD

0.873

0.881

0.928

0.930

0.895

gGSD

0.888

0.895

0.929

0.930

0.895

(\(\sqrt{0.5},\sqrt{0.5}\))

(\(\sqrt{0.7},\sqrt{0.3}\))

AD

0.894

0.903

0.939

0.941

0.904

gGSD

0.908

0.916

0.938

0.940

0.904

(\(\sqrt{0.7},\sqrt{0.3}\))

(\(\sqrt{0.7},\sqrt{0.3}\))

AD

0.900

0.910

0.945

0.947

0.908

gGSD

0.913

0.922

0.945

0.947

0.909

(\(\sqrt{0.8},\sqrt{0.2}\))

(\(\sqrt{0.8},\sqrt{0.2}\))

AD

0.903

0.914

0.945

0.948

0.905

gGSD

0.915

0.925

0.946

0.948

0.906

(\(\sqrt{0.6},\sqrt{0.4}\))

(\(\sqrt{0.6},\sqrt{0.4}\))

AD

0.890

0.899

0.939

0.941

0.903

gGSD

0.904

0.913

0.939

0.941

0.904

  1. aWeights defined in early text based on observed interim events and planned final events
  2. The power for sub-group (S) is calculated among 10,000 simulations with the sub-group passes the futility boundary. Similarly, the power for sub-group and full group (S &F) is calculated among 10,000 simulations with both the sub-group and full group pass the futility boundary