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

Clin Trials. 2005;2(4):340-51; discussion 352-8, 364-78. doi: 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.

MeSH terms

  • Bayes Theorem*
  • Clinical Trials, Phase II as Topic / methods*
  • Dose-Response Relationship, Drug*
  • Humans
  • Neuroprotective Agents / administration & dosage*
  • Neuroprotective Agents / therapeutic use
  • Stroke / drug therapy*

Substances

  • Neuroprotective Agents