RE:RE:RE:RE:RE:RE:Question Directly off the FDA website
Patient Population (1.4.3.2)
Selection of subjects for an active control trial can affect outcome; the population studied should
be carefully considered in evaluating what the trial has shown. For example, if many subjects in
a trial have previously failed to respond to the control treatment, there would be a bias in favor of
the new treatment. The results of such a trial could not be generalized to the entire population of
previously untreated patients. A finding of superiority of the new treatment, however, still would
be evidence of the efficacy of the new treatment in the population studied. In fact, a trial of a
new treatment in apparent nonresponders to another treatment, in which the nonresponders are
randomized to either the new or failed treatment (so long as this does not place the patients at
risk), can provide a demonstration of the value of the new treatment in such nonresponders, a
clinically valuable observation