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ASTIN: a Bayesian adaptive dose-response trial in acute stroke.

Clinical Trials (London, England)

Bayes Theorem, drug therapy, Stroke, therapeutic use, administration & dosage, Neuroprotective Agents, Humans, Dose-Response Relationship, Drug, methods, Clinical Trials, Phase II as Topic

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      Abstract

      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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      16281432

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