Sample Size Calculation Using Proportional Time for Noninferiority Trials

Number of arms

2-arm trial

3-arm trial

Method preferred

Non-inferiority Margin Method

Synthesis Method

Primary Goal

Experimental treatment is superior to the placebo

Experimental treatment is noninferior to the control group

Secondary Goal (Experimental treatment is noninferior to the control group)

Yes

Design Parameters

Noninferiority Margin M

Retention Rate RE for 2-arm sythesis method

Significance level Alpha

Power P

Allocation ratio R (ratio between the treatment and the control group)

Allocation ratio between the treatment and the placebo

Delta_PE(between treatment group and the placebo group)

Retention rate c (to be used only for 3-arm noninferiority trial)

Delta_PC(only applicable to the secondary goal.The ratio between placebo and control for 3-arm trial)

Variation Inflation Factor VIF

GG Parameters and Event Rate

User Entry

Estimate Using Prior Study

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Sample Size Calculation Using Proportional Time for Noninferiority Trials

For the method used to develop the application, please View the paper

Software Use Agreement: Please make sure that the data set doesn't contain any Patient Health Information