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Abstract:
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treatment switching effect between a test and a reference product is of great interest to both regulatory agencies and the industry. To achieve such a property, the test and the reference products need to demonstrate to produce the same clinical result in any given patient. However, there is no detailed recommendation in the FDA Guidance on the trial design or data analysis on the demonstration of treatment switching effect. Currently, it is not clear how to assess such an effect through appropriate designs. In this project,we propose a statistical testing procedure based on the 4 sequence and two sequences replicate crossover trial designs to evaluate treatment switching effect. We also derive the power function of the tests. The last step of our project is to perform efficiency comparison using the two designs.
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