
I have reviewed so many MedTech clinical study protocols and almost all of them have the same problem...
The sample size "justification" looks something along these lines:
❝... using a power of 0.8 and an alpha of 0.05, a sample size of 104 patients was determined to be sufficient.
This is not a justification, that's a sentence.
Before you even open claude code (or a calculator - if you're more into the classics) or call a biostatistician, there are 4 decisions only you can make. Get those wrong, and the math means nothing.
Made a quick reference for this. Save it. Bookmark or whatever you like :)
#MedTech #ClinicalTrials #MedicalDevices #Founders

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