Vladimir Dragalin

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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(More)
There is a growing interest amongst clinical investigators in the conduct of single trials combining the safety exploration of phase I with the initial investigations of efficacy usually made during phase II. This is being made increasingly possible through the use of biomar-kers that show early signs of physiological changes that are associated with a(More)
This paper uses a recently completed study to illustrate how adaptive trial designs can increase efficiency of psychiatric drug development. The design employed allowed a continuous reassessment of the estimated dose-response such that patients were randomized in a double-blind fashion to one of seven doses of the investigational drug, placebo, or active(More)
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