Journal
STATISTICS IN MEDICINE
Volume 33, Issue 19, Pages 3241-3252Publisher
WILEY
DOI: 10.1002/sim.6169
Keywords
comparisons with control; multi-arm multi-stage (MAMS) design; multiple comparisons; family-wise error (FWE) rate; sequentially rejective methods; estimation bias
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Funding
- Intramural NIH HHS [Z99 AI999999] Funding Source: Medline
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This paper presents a simple procedure for clinical trials comparing several arms with control. Demand for streamlining the evaluation of new treatments has led to phase III clinical trials with more arms than would have been used in the past. In such a setting, it is reasonable that some arms may not perform as well as an active control. We introduce a simple procedure that takes advantage of negative results in some comparisons to lessen the required strength of evidence for other comparisons. We evaluate properties analytically and use them to support claims made about multi-arm multi-stage designs. Published 2014. This article is a U. S. Government work and is in the public domain in the USA.
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