2.3 Theories of Group Sequential Tests

2.3.1 General Framework

In this section, we define the test statistic to be monitored and specify its distributional properties. This distributional theory is presented first in terms of a general framework which is then applied to studies with normal, binomial, and time-to-failure outcomes.
In the simplest situation, if we consider a two-arm randomized clinical trial comparing a test treatment with a control treatment, we can denote the treatment difference by a parameter theta, which is also sometimes known as the effect metric. Depending on the stochastic model one chooses for the endpoint of interest, the ...

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