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)
OBJECTIVE To examine whether penicillin treatment success for group A beta-hemolytic streptococcal tonsillopharyngitis is influenced by patient age, number of days ill prior to initiation of treatment, number of prior episodes, season, total dosage (milligrams per kilogram), and frequency of administration (2 vs 3 times daily). METHODS Four hundred(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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