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Exact Tests using Two Correlated Binomial Variables in Contemporary Cancer Clinical Trials
Author(s) -
Yu Jihnhee,
Kepner James L.,
Iyer Renuka
Publication year - 2009
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200900082
Subject(s) - bivariate analysis , univariate , sample size determination , clinical trial , binomial distribution , medicine , statistics , oncology , mathematics , multivariate statistics
New therapy strategies for the treatment of cancer are rapidly emerging because of recent technology advances in genetics and molecular biology. Although newer targeted therapies can improve survival without measurable changes in tumor size, clinical trial conduct has remained nearly unchanged. When potentially efficacious therapies are tested, current clinical trial design and analysis methods may not be suitable for detecting therapeutic effects. We propose an exact method with respect to testing cytostatic cancer treatment using correlated bivariate binomial random variables to simultaneously assess two primary outcomes. The method is easy to implement. It does not increase the sample size over that of the univariate exact test and in most cases reduces the sample size required. Sample size calculations are provided for selected designs.