Posted by Michael Wonder on 28 Jun 2018
Bias, operational bias, and generalisability in Phase II/III trials
27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to be made earlier, while protecting the interests of the patients in the trials.
In settings in which a randomised phase II efficacy signal is required to justify starting a large phase III trial, a phase II/III (seamless) design can sometimes be used to adaptively combine randomised phase II and phase III trial components. After the phase II part of the trial is enrolled and the phase II outcome is sufficiently mature, a go/no-go decision is made regarding whether to continue accrual to the phase III part of the trial.
The phase II patients are used in the final phase III analysis, and a separate phase III protocol need not be developed. This design offers efficiency gains relative to performing an independent phase III trial after a positive phase II trial. In general, the phase II analysis is performed confidentially solely to make a go/no-go decision, and the phase II results are not released to the public.
