Abstract
Ever escalating costs of pharmaceutical research and development [1] have prompted a drive for greater efficiency in clinical trial design. This has included use of surrogate outcomes [2], biomarker/genetic-based designs [3] and promotion of a range of adaptive designs [4]. While the broader class of adaptive designs includes adaptive randomization (using either minimization or stratification), here we focus on response adaptive designs, where the design is modified during the course of the trial based on the responses (either on a safety indicator or an efficacy outcome or both) of participants who have already been enrolled in the trial. Here, we undertake a brief tour of three key areas in which adaptive designs provide an effective contribution to drug development and then consider some implications of applying adaptive designs in practice.
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