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, ...