I have two groups of patients, responders (~75%) and non-responders (~25%) to a treatment. I want to look for a difference between them in a single biomarker (which I have not yet measured). The biomarker is non-parametric, although it has not been measured in this disease group before.

I am aiming to look at this in two different ways:

(1) Taking a single measurement from patients currently on treatment (mix of responders & non-responders). From a previous study of the same biomarker in a different disease group, I can estimate the median values for each group. I hypothesize that the biomarker is higher in responders. I would then perform a Mann Whitney test on my unpaired, non-parametric data.

(2) Prospectively sampling a group of treatment-naive subjects pre- and post-treatment. I hypothesize that responders have higher baseline levels of the biomarker and a greater reduction with treatment than non-responders. I would then perform a Wilcoxon test on my paired, non-parametric data.

How do I calculate the sample size for (1) and (2)?

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