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Sample size determination for the weighted log‐rank test with the Fleming–Harrington class of weights in cancer vaccine studies
Author(s) -
Hasegawa Takahiro
Publication year - 2014
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.1609
Subject(s) - mathematics , sample size determination , statistics , rank (graph theory) , class (philosophy) , log rank test , sample (material) , medicine , survival analysis , combinatorics , computer science , artificial intelligence , chemistry , chromatography
In recent years, immunological science has evolved, and cancer vaccines are available for treating existing cancers. Because cancer vaccines require time to elicit an immune response, a delayed treatment effect is expected. Accordingly, the use of weighted log‐rank tests with the Fleming–Harrington class of weights is proposed for evaluation of survival endpoints. We present a method for calculating the sample size under assumption of a piecewise exponential distribution for the cancer vaccine group and an exponential distribution for the placebo group as the survival model. The impact of delayed effect timing on both the choice of the Fleming–Harrington's weights and the increment in the required number of events is discussed. Copyright © 2014 John Wiley & Sons, Ltd.