Advantages of integrated trials for performing multiple Phase II studies.

Phase II trials can be conducted in an integrated fashion that minimizes assignment of patients to potentially ineffective treatments. The technique allows definitions of response to include survival; earlier identification of more effective drugs; and completion of more Phase II studies in a given time period. It also encourages investigators to analyse results promptly. Because the analysis of each trial is independent, the statistical power of the analysis of results is retained. Identified shortcomings of the method include the need for a central mechanism to assign patients to treatment, the need for several drugs to be tested, physicians' uncertainty about which drug a particular patient will receive, and the increased time it may take to complete an individual trial.