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

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.

• Authors: Andrew P Grieve, Michael Krams
• Journal: Clinical trials (London, England) (Clin Trials) Vol. 2 Issue 4 Pg. 340-51; discussion 352-8, 364-78 ( 2005) ISSN: 1740-7745 [Print] England
• PMID: 16281432 (Publication Type: Journal Article)

Chemical References

• Neuroprotective Agents

Topics

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