ABSTRACT

There are some key principles that are important in interpretation of any study. They apply to the interpretation of adaptive designs. These are summarized in this section.

Interpretation of a trial consists of two steps. The rst step is assessing internal validity of the study. This is the process of guring out what the results tell us about the drug’s effectiveness within the trial. The second is external validation or the process of taking the study results and extrapolating them to the patient population at large, to patients who were not entered in the trial. It is the process of reaching conclusions about how the therapy should or should not be used for patients in clinical practice.