Sample Size Determination
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Clinical Trial: Non-inferiority Design (Dichotomous outcome variable)
This utility can be used to calculate required sample size for a clinical trial with non-inferiority design and the outcome variable is dichotomous.
Formula used and other details
Your guesstimate of Proportion of desired outcome in test arm (P1)
Enter positive number between 0.01 to 99.99
Required
Approxiate estimate of Proportion of participants in test arm with desired outcome, based on previous studies / pilot studies etc. In percentage. (Between 0.01 to 99.99)
Your guesstimate of Proportion of desired outcome in control arm (P2).
Enter positive number between 0.01 to 99.99
Required
Approxiate estimate of Proportion of participants in control arm with desired outcome, based on previous studies / pilot studies etc. In percentage. (Between 0.01 to 99.99)
Ratio of Sample Size in two arms (Groups) (N2 / N1)
Enter number from 0.01 to 9.00
Required
Sample Size in Group 2 (control arm) / Sample Size in Group 1 (test arm)
Confidence Level %
Enter positive number between 0.01 to 99.99
Required
In percentage. Commonly used values are 95, 99 and 90. Should be between 0.01 to 99.99.
Power ( 1 - β)
Enter positive number between 0.01 and 99.99
Required
In Percentage. Should be between 0.01 to 99.99. Common values are 80 % and 90 %
Clinically Acceptable Margin for non-inferiority (d)
Required
It is the clinically significant margin to define non-inferiority. Test arm proportion should not be less than control arm proportion by this non-inferority margin to consider test intervention is non-inferior to control intervention. In percentage. (Between 0.01 to 99.99)
One sided test
Being a non-inferiority design, hypothesis test is always one sided
Sample Size Required =