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

Publication date: 2004-12-31

Journal: Clinical Trials (London, England)

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

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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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PubMed ID:: 16281432

ScienceOpen disciplines: Chemistry

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

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ScienceOpen disciplines: Chemistry

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

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

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