Background The classification of phase 3 trials as superiority or non-inferiority has become routine, and it is widely accepted that there are important differences between the two types of trial in their design, analysis and interpretation. Main text There is a clear rationale for the superiority/non-inferiority framework in the context of regulatory trials. The focus of our article is non-regulatory trials with a public health objective. First, using two examples from infectious disease research, we show that the classification of superiority or non-inferiority trials is not always straightforward. Second, we show that several arguments for different approaches to the design, analysis and interpretation of superiority and non-inferiority...
Non-inferiority clinical trials are being performed with an increasing frequency now-a-days, because...
Clinical trial is a research conducted to test the effectiveness and safety of the experimental drug...
Clinical trials are an essential part of the drug development life cycle. There are different types ...
Background The classification of phase 3 trials as superiority or non-inferiority has become routine...
Abstract Background The classification of phase 3 trials as superiority or non-inferiority has becom...
Abstract Background Current regulatory guidance and practice of non-inferiority trials are asymmetri...
Superiority trials are conducted to test the hypothesis that a treatment or strategy A is superior t...
With improvements in care over time it becomes harder to improve clinical outcomes in those conditio...
There is a knowledge gap in designing so-called “non-inferiority trials”, which aim to show whether ...
A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In...
The non-inferiority trial design has gained popularity within the last decades to compare a new trea...
Demonstrating non-inferiority in clinical trials is usually more challenging than showing superiorit...
Despite decades of experience with non-inferiority trials, they remain a source of great controversy...
The non-inferiority trial design has gained popularity within the last decades to compare a new trea...
BACKGROUND: The smallest difference to be detected in superiority trials or the largest difference t...
Non-inferiority clinical trials are being performed with an increasing frequency now-a-days, because...
Clinical trial is a research conducted to test the effectiveness and safety of the experimental drug...
Clinical trials are an essential part of the drug development life cycle. There are different types ...
Background The classification of phase 3 trials as superiority or non-inferiority has become routine...
Abstract Background The classification of phase 3 trials as superiority or non-inferiority has becom...
Abstract Background Current regulatory guidance and practice of non-inferiority trials are asymmetri...
Superiority trials are conducted to test the hypothesis that a treatment or strategy A is superior t...
With improvements in care over time it becomes harder to improve clinical outcomes in those conditio...
There is a knowledge gap in designing so-called “non-inferiority trials”, which aim to show whether ...
A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In...
The non-inferiority trial design has gained popularity within the last decades to compare a new trea...
Demonstrating non-inferiority in clinical trials is usually more challenging than showing superiorit...
Despite decades of experience with non-inferiority trials, they remain a source of great controversy...
The non-inferiority trial design has gained popularity within the last decades to compare a new trea...
BACKGROUND: The smallest difference to be detected in superiority trials or the largest difference t...
Non-inferiority clinical trials are being performed with an increasing frequency now-a-days, because...
Clinical trial is a research conducted to test the effectiveness and safety of the experimental drug...
Clinical trials are an essential part of the drug development life cycle. There are different types ...