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

Andrew P Grieve

Statistical Research and Consulting Centre, Pfizer Global Research and Development, Sandwich, Kent CT13 9NJ, UK; Andy.P.Grieve{at}Pfizer.Com

Michael Krams

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

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.

Clinical Trials, Vol. 2, No. 4, 340-351 (2005)
DOI: 10.1191/1740774505cn094oa
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