Phase II/III Designs

Authored by: Sally Hunsberger

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/b11800-15

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Abstract

Phase II/III, seamless phase II/III, and integrated II/III designs are terms that are used interchangeably and refer to study designs that combine aspects of phase II drug development and phase III drug development into one study. Phase II/III designs randomize patients in the phase II component and then include these patients in the phase III component of the study. An intermediate end point is evaluated in the phase II component.

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