Clin Trials. 2005;2(4):340-51; discussion 352-8, 364-78.

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

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Statistical Research and Consulting Centre, Pfizer Global Research and Development, Sandwich, Kent, UK. Andy.P.Grieve@Pfizer.Com

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.

PMID:: 16281432; [PubMed - indexed for MEDLINE]

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Neuroprotective Agents

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New England Research Institutes Inc.

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Stroke - MedlinePlus Health Information

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