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Table 6 Theoretical and specified parameters for the illustrative example

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

 

GSD

gGSD

Subgroup

Full Group

Subgroup

Full Group

Analysis

Boundary

& p-value

PFS

OS

PFS

OS

PFS

OS

PFS

OS

IA1

Nominal p-value

boundary

0.0036

0.0017

 < 0.0001

 < 0.0001

0.0037

0.0017

0.0039

0.0024

Data generated p-value

0.0177

0.1205

0.0008

0.0104

–

–

0.0022

0.0125

IA2

Nominal p-value

boundary

0.0088

0.0078

0.0002

0.0001

0.0090

0.0079

0.0089

0.0088

Data generated p-value

0.0137

0.0502

0.00022

0.0023

–

–

–

0.0019

FA

Nominal p-value

boundary

 

0.0120

 

0.0002

 

0.0122

 

0.0119

Data generated p-value

 

0.0534

 

0.0011

 

–

 

–

  1. The nominal p-value is the p-value boundary in a typical group sequential design under the allocated alpha in different IA time
  2. The data generated p-value is the p-value from the test using the trial data
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BMC Medical Research Methodology

ISSN: 1471-2288

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