Applying a phase II futility study design to therapeutic stroke trials

  • Palesch Y
  • Tilley B
  • Sackett D
 et al. 
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Abstract

Most large, randomized phase III efficacy trials of therapeutic agents in ischemic stroke have failed to find treatment benefit. We determined whether some phase III studies could have been avoided if preceded by smaller single-arm phase II studies to evaluate the futility of proceeding to phase III.

Author-supplied keywords

  • Clinical trials, phase II
  • Ischemia
  • Stroke

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Authors

  • Yuko Y. Palesch

  • Barbara C. Tilley

  • David L. Sackett

  • Karen C. Johnston

  • Robert Woolson

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