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Clin Cancer Res. 2012 Apr 15;18(8):2130-2. doi: 10.1158/1078-0432.CCR-12-0454. Epub 2012 Mar 8.

Choosing phase II endpoints and designs: evaluating the possibilities.

Author information

1
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, USA. mleblanc@fhcrc.org

Abstract

Selecting the phase II design and endpoint to achieve the best possible chance of success for a confirmatory phase III study in a particular disease and treatment setting is challenging but critical. Simulating from existing clinical trial data sets and from mathematical models can be useful tools for evaluating statistical properties.

PMID:
22407830
PMCID:
PMC4820349
DOI:
10.1158/1078-0432.CCR-12-0454
[Indexed for MEDLINE]
Free PMC Article

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