ASTIN: a Bayesian adaptive dose–response trial in acute stroke-Reference-Cited by-同舟云学术

ASTIN: a Bayesian adaptive dose–response trial in acute stroke

Published:2005-08 Issue:4 Volume:2 Page:340-351
ISSN:1740-7745
Container-title:Clinical Trials
language:en
Short-container-title:Clinical Trials

Author:

Grieve Andrew P¹,Krams Michael²

Affiliation:

1. Statistical Research and Consulting Centre, Pfizer Global Research and Development, Sandwich, Kent CT13 9NJ, UK;

2. Clinical CNS, Pfizer Inc., Groton, Connecticut, CT 06340 USA

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.

Publisher

SAGE Publications

Subject

Pharmacology,General Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1191/1740774505cn094oa

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