Sample size calculation non inferiority trial

Background: Non-inferiority trials are performed when the main therapeutic effect of the new therapy is expected to be not unacceptably worse than that of the standard therapy, and the new therapy is expected to have advantages over the standard therapy in costs or other health consequences.

These advantages however are not included in the classic frequentist approach of sample size calculation for non-inferiority trials. In contrast, the decision theory approach of sample size calculation does include these factors. Consequently, if sample size is fixed, there will be less power for the relative change equivalent to any given absolute change.

For the above reason it is important to know and state beforehand if one is going to be interested in percentage change or if absolute change is of primary interest. Then it is just a matter of fliping a radio button. Forster Eds. Handbook of the Philosophy of Science.

The Netherlands: Elsevier. If you'd like to cite this online calculator resource and information as provided on the page, you can use the following citation: Georgiev G. Calculators Converters Randomizers Articles Search. Sample Size. Experiment for. Differences between. The data is. Alternative H 1 is for. Inference about. Treatment groups. Input variables as. Sample size. Proportion under H 0. Mean under H 0. Standard deviation.

Superiority margin. Share calculator:. Sample size estimation in clinical research: from randomized controlled trials to observational studies. Chest, 1 , pp. Sample size formulas for different study designs: supplement document for sample size estimation in clinical research. Reference Example.

Sample Size Calculations in Clinical Research. Schoenfeld D. Statistical Methods for Rates and Proportions. A case-control study of the relationship between smoking and CHD is planned. A sample of men with newly diagnosed CHD will be compared for smoking status with a sample of controls.

Assuming an equal number of cases and controls i. Previous surveys have shown that around 0. Dupont WD. Power calculations for matched case-control studies. The sample size calculator will initially determine how many subjects are required to complete the trial and appear in the final analysis.

A percentage of patients will usually not complete the trial and therefore will not contribute to the final analysis. With nearly 3 quarters of a million attempts at these Challenges they are used across the World to test, learn and document knowledge. About PharmaSchool Contact.

PharmaSchool Sample Size Calculator Type: Binary Non-Inferiority The calculator below is to determine the sample size for a 2 arm, randomised, parallel group trial with the outcome variable being binary and the objective of showing non-inferiority.

HELP: If you would like help in completing the sample size calculation click help off.