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Adaptive designs for clinical trials permit alterations to a study inresponse to accumulating data in order to make trials more flexible, ethicaland efficient. These benefits are achieved while preserving the integrity andvalidity of the trial, through the pre-specification and proper adjustment forthe possible alterations during the course of the trial. Despite much researchin the statistical literature highlighting the potential advantages of adaptivedesigns over traditional fixed designs, the uptake of such methods in clinicalresearch has been slow. One major reason for this is that different adaptationsto trial designs, as well as their advantages and limitations, remainunfamiliar to large parts of the clinical community. The aim of this paper isto clarify where adaptive designs can be used to address specific questions ofscientific interest; we introduce the main features of adaptive designs andcommonly used terminology, highlighting their utility and pitfalls, andillustrate their use through case studies of adaptive trials ranging fromearly-phase dose escalation to confirmatory Phase III studies.

Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs