Table 4 on p. 7. In the paper by Catello and Watts are for non-inferiority test for lognormal data or ratio of two geometric means. We would like to know if SAS proc power can computer the power/sample size for non-interiority test of two correlated proportions. A good example for this issue is illustrated in FDA guidance "Comparative Analysis and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA" http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536959.pdf In the proposed study, each subject will test for two different medical devices (old device and new device). The error rates for using old device and using new device will then be calculated. The assumption is that if a patient is good at using the old device, he/she will be also good at using the new device. In other words, the error rate for using the old device is correlated with the error rate using the new device. If we are trying to design a non-inferiority study as outlined in FDA's guidance, will SAS proc power be used for calculating the power/sample size? The FDA guidance provided examples for sample sizes that were generated using the simulation.
... View more