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A comparison of multiple hypothesis testing methods and combination methods in seamless Phase II/III clinical trials

Authors
Han, SongYoo, HannaLee, 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
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/67769
DOI
10.5351/KJAS.2019.32.1.001
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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