An introduction to adaptive designs and adaptation in CNS trials

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.