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Two-stage phase II trials with early stopping for effectiveness and safety as well as ineffectiveness or harm

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  • Shixin Li
  • Hua Jin
  • Wanyi Chen

Abstract

This article proposes new optimal and minimax designs, which allow early stopping not only for ineffectiveness or toxicity but also for sufficient effectiveness and safety. These designs may facilitate effective drug development by detecting sufficient effectiveness and safety at an early stage or by detecting ineffectiveness or excessive toxicity at an early stage. The proposed design has advantage over other designs in the sense that it can control the type I error rate and is robust against the real association parameter. Comparing to Jin's design, it is always advantageous in terms of expected sample size.

Suggested Citation

  • Shixin Li & Hua Jin & Wanyi Chen, 2018. "Two-stage phase II trials with early stopping for effectiveness and safety as well as ineffectiveness or harm," Communications in Statistics - Theory and Methods, Taylor & Francis Journals, vol. 47(22), pages 5626-5638, November.
    • Handle: RePEc:taf:lstaxx:v:47:y:2018:i:22:p:5626-5638
    DOI: 10.1080/03610926.2017.1400054
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