Overview of Phase II Clinical Trials

Authored by: Stephanie Green

Handbook of Statistics in Clinical Oncology

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

Print ISBN: 9781439862001
eBook ISBN: 9781439862018
Adobe ISBN:


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Standard phase II studies are used to screen new regimens for activity and to decide which ones should be tested further. To screen regimens efficiently, the decisions generally have been based on single-arm studies using short-term endpoints, typically tumor response in cancer studies, in limited numbers of patients. The problem is formulated as a test of the null hypothesis H 0: p = p 0 versus the alternative hypothesis H A: p = p A, where p is the probability of response, p 0 is the probability that if true would mean that the regimen was not worth studying further, and p A is the probability that if true would mean it would be important to identify the regimen as active and to continue studying it. Typically, p 0 is a value at or somewhat below the historical probability of response to standard treatment for the same stage of disease, and p A is typically somewhat above.

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