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A comparison of multiple hypothesis testing methods and combination methods in seamless Phase II/III clinical trials
- Authors
- Han, Song; Yoo, Hanna; Lee, Jae Won
- Issue Date
- 2월-2019
- Publisher
- KOREAN STATISTICAL SOC
- Keywords
- adaptive design; seamless design; multiple testing; combination tests; Phase II design; Phase III design
- Citation
- KOREAN JOURNAL OF APPLIED STATISTICS, v.32, no.1, pp.1 - 13
- Indexed
- KCI
- Journal Title
- KOREAN JOURNAL OF APPLIED STATISTICS
- Volume
- 32
- Number
- 1
- Start Page
- 1
- End Page
- 13
- ISSN
- 1225-066X
- Abstract
- 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.
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