Clinical Trials · 2005 · 85 citations · 8 references
MedicinePharmacologyPharmacotherapyClinical PharmacologyDose-response ModelingDrug DesignAcute Stroke ManagementBayesian Adaptive DesignBayesian Clinical TrialsNeuroprotectionStrokeStroke PharmacotherapyAdaptive Bayesian DosingAdaptive DesignAdaptive Dose-findingBayesian Adaptive Trial DesignBayesian Dose OptimizationBayesian Dosing AlgorithmsDiscontinuation DecisionsDose-finding Trial Design
Understanding the dose-response is critical for successful drug development. We describe an adaptive design to efficiently learn about the dose-response and the ED95. A dynamic termination rule allows for early discontinuation either for efficacy or futility. The design was deployed in ASTIN, a phase II proof-of-concept trial of the neuroprotectant, neutrophil inhibitory factor (NIF), in acute stroke. We discuss the learning from this trial.
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Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN)
Michael Krams, Kennedy R. Lees, Werner Hacke et al. · Stroke · 2003 · 429 citations