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i don't know if anyone can shed some light on the topic of working with trials that involve difference between proportions (end point involves success/fail alternatives). what we are trying to do is to compare a drug A vs. a combination drug A and adding Drug B to check if there is an added value to the combination versus the drug in single use. what i've been looking at so far is superiority design and non-inferiority hypothesis?
i just need to know:
the sample size is lower in non-inferiority compared to superiority testing but just choosing the design on sample size is not a smart practice. is non-inferiority testing limited to BE/BA kind of studies? or can we achieve answering my research question through non-inferiority testing and then it is just the way we present the hypothesis with that regard somthing like two sided versus one sided testing? and again if my way of looking at achieving answers for my study can only be achieved through superiority testing are we limited to the way we calculate the sample size and have to accept what ever the already reported equations state.
thanks and happy new year!
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