Guidance on Anti-Infective Non-Inferiority Margins May Not Be Clear-Cut
Executive Summary
FDA is expected to provide some much-desired clarity on its policy for non-inferiority margins in clinical trials for anti-infectives at this week's advisory committee meeting. But the end result may not be the concrete answer that industry is hoping for
You may also be interested in...
Panel Accepts FDA's Statistical Take On Micardis, Recommends Limited Use
FDA's Cardiovascular and Renal Drugs Advisory Committee sided with FDA's more conservative statistical analysis of Boehringer Ingelheim's Micardis, rejecting the company's claim that telmisartan demonstrated non-inferiority to ramipril in a pivotal trial
Panel Accepts FDA's Statistical Take On Micardis, Recommends Limited Use
FDA's Cardiovascular and Renal Drugs Advisory Committee sided with FDA's more conservative statistical analysis of Boehringer Ingelheim's Micardis, rejecting the company's claim that telmisartan demonstrated non-inferiority to ramipril in a pivotal trial
Industry’s Lesson On Non-Inferiority Margins In Anti-Infective Trials: Use 10%
If industry is to learn anything from the three-day Anti-Infective Drugs Advisory Committee meeting on how to correctly use non-inferiority margins in trials, it is to adhere to the panel's recommendation of 10 percent (at least for now)