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Avoid wide non-inferiority margins in your clinical study design - Vinay Bhal on BoneChat #30 short

7 Jun 2024 · 1 min

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0:33

Vinay Bhal explains why wide non-inferiority margins weaken clinical trials. They inflate sample sizes, lengthen enrollment, and invite confounding from diverse patient populations. Narrow, realistic margins tied to clear success criteria matter more.

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If you have a very wide non-inferiority margin, then that's an indicator that that's not a good design. Because one, it will increase your sample size. You will be enrolling for a longer time. And therefore, it will be taking— you will confound with more patients. You will confound your results. You could possibly confound. So those are the things that you can look at. Rates that they are using, or like, for example, what's the criteria for success of the study?

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