Non-Superiority [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-07-26 15:04 (17 d 23:40 ago) – Posting: # 23179
Views: 313

Hi Dennis,

» » You hope that the complication rates in group A (with medicine) are lower than in group B (without medicine), right?
»
» However, we try to show the complication rates in group B (without medicine) are lower (or not worse or non-inferiority) than in group A (with medicine), …

Essentially you are trying to show that the medicine doesn’t perform better than placebo (assuming the study is double-blind). :-D:blind:

» … duo to the medicine is very expensive.

Likely you will face problems with the IEC/IRB:It is the job of the IEC/IRB to make a benefit/risk-assessment for the subjects in the study. To assess a potential socio-econommic advantage for the health system is not in the job description of the members.

» Is there any other probelm for the design?

IMHO, ethics.



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