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DOI: 10.1191/1740774505cn094oa ASTIN: a Bayesian adaptive doseresponse trial in acute strokeStatistical Research and Consulting Centre, Pfizer Global Research and Development, Sandwich, Kent CT13 9NJ, UK; Andy.P.Grieve{at}Pfizer.Com
Clinical CNS, Pfizer Inc., Groton, Connecticut, CT 06340 USA Understanding the doseresponse is critical for successful drug development. We describe an adaptive design to efficiently learn about the doseresponse 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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