Phase II Selection

Authored by: P.Y. Liu , James Moon , Michael LeBlanc

Handbook of Statistics in Clinical Oncology

Print publication date:  March  2012
Online publication date:  March  2012

Print ISBN: 9781439862001
eBook ISBN: 9781439862018
Adobe ISBN:

10.1201/b11800-13

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Abstract

When there are multiple promising new therapies in a disease setting, it may not be feasible to test all of them against the standard treatment in a definitive phase III trial. The sample sizes required for a phase III study with more than three arms could be prohibitive [1]. In addition, the analysis can be highly complex and prone to errors due to the large number of possible comparisons in a multi-arm study. An alternative strategy is to screen the new therapies first in a phase II setting and choose one to test against a standard treatment in a simple two-arm phase III trial. Selection designs can be used in such circumstances.

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