Sample size estimation methods for different study goals of factorial de-sign in clinical trials
Aim:To analyze sample size estimation methods for different study goals of 2×2 factorial design in clinical trials.Methods:Factorial clinical trials can be set with 5 study goals,and the goal-oriented sample size estimation methods were analyzed.An actual clinical trial employing 2×2 factorial design were subjected,its assumptions,parameter settings,and data results were used to demonstrate the application of sample size estimation method for different study goals.Re-sults:Sample size estimation methods for factorial design should be chosen based on different study goals and analysis strat-egies,such as factorial analysis,multiarm analysis,Bonferroni correction procedure,three-step procedure,Hochberg proce-dure,and Hommel procedure.The analysis of the example application showed that estimating sample size solely based on the inference of main effects in a factorial trial was inadequate for other study goals.It is necessary to employ appropriate sample size estimation methods tailored to specific goals to avoid issues of insufficient statistical power.Conclusion:For factorial design,appropriate sample size estimation methods should be selected in accordance with the study goals.
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