Sample size determination in superiority or non-inferiority clinical trials with time-to-event data under exponential, Weibull and Gompertz distributions

DOI10.1080/03610918.2021.1879137MaRDI QIDQ6171850zbMATH OpenOpenAlexWikidataFDO

Authors Dong Han, Yawen Hou, Zheng Chen

Publication date 18 July 2023

Published in Communications in Statistics. Simulation and Computation (Search for Journal in Brave)

Full work available at URL https://arxiv.org/abs/1808.03831

zbMATH Keywords

survival analysisWeibull distributionsample sizeexponential distributionnon-inferiority trialssuperiority trials

Mathematics Subject Classification ID

Statistics (62-XX)

Abstract: To examine the effect of exponential, Weibull and Gompertz distributions on sample size determination for superiority trials (STs) or non-inferiority trials (NTs) with time-to-event data, we present two sample size formulas for STs or NTs based on Weibull and Gompertz distributions, respectively. The formulas are compared with the current exponential formula to examine their performance. The simulation results show that the sample size formula based on the Weibull distribution is the most robust among the three formulas in STs or NTs. We suggest that recognizing the appropriate distribution in advance is beneficial for proper project planning and that assuming a Weibull distributed survival time is most advantageous in STs or NTs.

Cites work

• Evaluation of Sample Size and Power for Analyses of Survival with Allowance for Nonuniform Patient Entry, Losses to Follow-Up, Noncompliance, and Stratification
• Sample Size Calculations in Clinical Research
• Sample-Size Formula for the Proportional-Hazards Regression Model

Cited in

(1)

• Sample size calculations for noninferiority trials for time-to-event data using the concept of proportional time

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