Three-component cure rate model for nonproportional hazards alternative in the design of randomized clinical trials.

Clinical Trials : Journal of the Society for Clinical Trials
H T Kim, Robert Gray

Abstract

Cure rate models have been extensively studied and widely used in time-to-event data in cancer clinical trials. Although cure rate models based on the generalized exponential distribution have been developed, they have not been used in the design of randomized cancer clinical trials, which instead have relied exclusively on two-component exponential cure rate model with a proportional hazards (PH) alternative. In some studies, the efficacy of the experimental treatment is expected to emerge some time after randomization. Since this does not conform to a PH alternative, such studies require a more flexible model to describe the alternative hypothesis. In this article, we report the study design of a phase III clinical trial of acute myeloid leukemia using a three-component exponential cure rate model to reflect the alternative hypothesis. A newly developed power calculation program that does not require PH assumption was used. Using a custom-made three-component cure rate model as an alternative hypothesis, the proposed sample size was 409, compared with a sample size of 209 under the assumption of exponential distribution and 228 under the PH alternative. A simulation study was performed to present the degree of power loss when...Continue Reading

References

Sep 30, 1999·Controlled Clinical Trials·B FreidlinS L George
Feb 24, 2001·Statistical Methods in Medical Research·B SpiessensD L DeMets
Sep 30, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Lawrence V RubinsteinMalcolm A Smith
Aug 10, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Luca MalcovatiMario Cazzola
Jan 20, 2009·Statistics in Medicine·Daowen Zhang, Hui Quan
Mar 12, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Larry RubinsteinDan Sargent
Sep 1, 2009·Proceedings of the National Academy of Sciences of the United States of America·Vincent T HoRobert Soiffer
Nov 26, 2009·Clinical Trials : Journal of the Society for Clinical Trials·John M Lachin

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Citations

Oct 8, 2013·Journal of the National Cancer Institute·Fangxin Hong, Richard Simon
Feb 3, 2016·BMC Medical Research Methodology·Tai-Tsang Chen
Oct 28, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Boris Freidlin, Edward L Korn

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