Journal
EUROPEAN NEUROPSYCHOPHARMACOLOGY
Volume 21, Issue 2, Pages 153-158Publisher
ELSEVIER
DOI: 10.1016/j.euroneuro.2010.09.004
Keywords
Adaptive design; Biomarker; Central Nervous System; Dose-ranging study; Seamless design
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Adaptive designs learn from accumulating trial data in real time and apply this knowledge to optimize subsequent study execution. A set of design rules define a priori which modifications may be incorporated into the trial design. Judicious use of adaptive designs may increase the information value per resource unit invested by avoiding allocation of patients to non-efficacious/unsafe therapies and allowing stopping decisions to be made at the earliest possible time point. Ultimately this may accelerate the development of promising therapies. (C) 2010 Elsevier B.V. and ECNP. All rights reserved.
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