ASTIN: a Bayesian adaptive dose–response trial in acute stroke
- 1 August 2005
- journal article
- research article
- Published by SAGE Publications in Clinical Trials
- Vol. 2 (4) , 340-351
- https://doi.org/10.1191/1740774505cn094oa
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.Keywords
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