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PAREXEL - The Ethical Benefits of Adaptive Trial Designs by Dr Sy Pretorius, Chief Scientific Office

February 26, 2015
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.
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