• Title/Summary/Keyword: 제 2상시험

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A comparison of multiple hypothesis testing methods and combination methods in seamless Phase II/III clinical trials (심리스 제2상/제3상 임상시험에서 다중가설검정방법과 결합검정방법의 비교연구)

  • Han, Song;Yoo, Hanna;Lee, Jae Won
    • The Korean Journal of Applied Statistics
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    • v.32 no.1
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    • pp.1-13
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    • 2019
  • An adaptive seamless Phase II/III clinical trial design enables a reduction in the sample size (in comparison to a conventional design) that also shortens the clinical development time. It is also very effective in clinical trials since it can have higher statistical power than Phase III alone. In this study, we use extensive simulation studies to compare several multiple hypothesis testing methods that can help select the best doses in a Phase II study along with several methods to combine p-values of the Phase II and Phase III study.