2.2 Examples of Classical Fixed-Sample Designs

Before we develop the theories of group sequential procedures in the next section, we will describe four examples of clinical trials that were planned using the classical fixed-sample design. However, these trials can be modified into new designs that use the group sequential methods. Detailed interpretations will accompany programming codes to introduce the different approaches and to compare designs with varying parameters. Readers can adapt these codes to further explore different design specifications.
Example 1: Pravastatin Therapy in Children with Familial Hypercholesterolemia
Familial hypercholesterolemia (FH) is a genetic disorder characterized by high cholesterol levels in the blood, ...

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