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Assumptions of Expected Benefits in Randomized...
Journal article

Assumptions of Expected Benefits in Randomized Phase III Trials Evaluating Systemic Treatments for Cancer

Abstract

BACKGROUND: In designing phase III randomized clinical trials (RCTs), the expected magnitude of the benefit of the experimental therapy (δ) determines the number of patients required and the number of person-years of follow-up. We conducted a systematic review to evaluate how reliably δ approximates the observed benefit (B) in RCTs that evaluated cancer treatment. METHODS: RCTs evaluating systemic therapy in adult cancer patients published in …

Authors

Gan HK; You B; Pond GR; Chen EX

Journal

Journal of the National Cancer Institute, Vol. 104, No. 8, pp. 590–598

Publisher

Oxford University Press (OUP)

Publication Date

April 18, 2012

DOI

10.1093/jnci/djs141

ISSN

0027-8874