Two-stage Sequential Design
Two-Stage Sequential Design is a statistical inference framework in bioequivalence assessment that belongs to the class of adaptive clinical trial designs and is distinguished by its structured, pre-specified two-phase approach wherein the first stage estimates key parameters to inform the sample size and decision rules of a subsequent confirmatory stage, thereby optimizing trial efficiency and regulatory decision-making for Highly Variable Drug Products.
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2017–2026
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489
Optimal two-stage designs for phase II clinical trials
Richard Simon · Controlled Clinical Trials · 1989 · 3.6K citations
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Memorial Sloan Kettering Cancer Center
New York, United States
13 h-index
80 publications
4.9K citations
National Cancer Institute
Bethesda, United States
12 h-index
64 publications
7.6K citations
Heidelberg University
Heidelberg, Germany
11 h-index
44 publications
899 citations
Duke University
Durham, United States
11 h-index
13 publications
836 citations
Harvard University
Cambridge, United States
10 h-index
20 publications
4.3K citations
University of Wisconsin–Madison
Madison, United States
10 h-index
15 publications
2.1K citations
University of Reading
Reading, United Kingdom
10 h-index
14 publications
809 citations
MRC Biostatistics Unit
Cambridge, United Kingdom
10 h-index
14 publications
381 citations
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65 publications · 3.4K citations
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30 publications · 2.3K citations
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16 publications · 471 citations
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JBS · 21 publications · 459 citations
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