PAREXEL - The Ethical Benefits of Adaptive Trial Designs by Dr Sy Pretorius, Chief Scientific Office
There is an ethical benefit to adaptive trials in my opinion. Let me explain: Under the traditional trial paradigm patients would sometimes be in a treatment arm that is clearly not effective; adaptive trials give us the opportunity to either stop subjecting these patients to ineffective, or possible harmful doses, or to move these patients from an ineffective arm to a more effective treatment arm. A very attractive advantage of adaptive trials is that they allow us to address one of the biggest areas of concern in clinical trials today – the high failure rate of Phase III clinical trials. Today, approximately 50% of trials in Phase III fail which have a tremendous economic and social cost. A major reason for this failure is that the wrong dose is used in the Phase III trial. Several commonly-used adaptive designs target getting much more detail on the dose-response relationship by using accumulating data to adjust randomization allocations to the ‘best’ doses – those yielding better results. The result is to give sponsors a better chance to select the right dose in Phase III and to significantly increase the probability of success in Phase III trials.