Adaptive Trial Designs

Authored by: Brian P. Hobbs , J. Jack Lee

Handbook of Statistics in Clinical Oncology

Print publication date:  March  2012
Online publication date:  March  2012

Print ISBN: 9781439862001
eBook ISBN: 9781439862018
Adobe ISBN:


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Adaptive designs can be broadly defined as all designs that allow mid-trial modifications based on interim information from sources both internal and external to the trial. Methodology has been proposed to facilitate adaptivity for prospective modification to many features of clinic trial design. 1 3 For example, eligibility criteria can be modified to enrich the study population and enhance the chance of success. Adaptive randomization (AR) methods have been proposed based upon baseline covariates, 4 6 outcomes, 7 12 and biomarkers. 13 16 Several authors have proposed designs for phase I trials that use methods for adaptively allocating patients to dose levels. 17 23 Methods have been proposed for adding or dropping study arms (or doses) or sequential stopping, 24 33 for adaptive sample size reestimation, 34 40 adaptively modifying study endpoints or hypotheses, 41 43 and “seamless” designs that even adaptively alter the trial’s phase. 44 49

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