Journal article

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

Hui K Gan, Benoit You, Gregory R Pond, Eric X Chen

Journal of the National Cancer Institute | OXFORD UNIV PRESS INC | Published : 2012

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 10 journals from January 1, 2005, through December 31, 2009, were identified. Data were extracted from each publication independently by two investigators. The related-samples Sign test was used to determine whether the median difference between δ and B..

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University of Melbourne Researchers