ASTIN: a Bayesian adaptive dose-response trial in acute stroke.
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.
Grieve
Andrew P
AP
Statistical Research and Consulting Centre, Pfizer Global Research and Development, Sandwich, Kent, UK. Andy.P.Grieve@Pfizer.Com
Krams
Michael
M
D001499:Bayes Theorem; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D020521:Stroke / Q000188:drug therapy*
D018696:Neuroprotective Agents