A new device intends to prevent a bad event. With the current treatment the events occurs at 10% of patients undergoing the medical routine. The new device claims to be not worse than the current treatment (non-inferior), with some other added values. With these small proportions, to show non-inferiority takes hundreds of patients in each of the two groups, but this is a first pilot study, no sponsor will go for hundreds of people for a first trial. What would be your strategy in this case ?
Thank you Alvaro. You suggest a single arm trial. I thought about it, I used the Clopper-Pearson exact confidence interval and got similar results (10%). Do you know if it is allowed to sample two groups (new treatment and gold standard - only ethical treatments), and to set a primary endpoint for one arm only (similar to what you suggested) and a secondary endpoint that compares the groups - and could fail due to the lack of power ?
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