Assessing Equivalence and Non-Inferiority

New Tests for Assessing Non-Inferiority and Equivalence from Survival Data

We propose a new nonparametric method for assessing non-inferiority of an experimental therapy compared to a standard of care. The ratio E  R  of true median survival times is the parameter of interest. This is of considerable interest in clinical trials of generic drugs. We think of the ratio E R m m of the sample medians as a point estimate of the ratio E R   . We use the Fieller-Hinkley ...

Non-inferiority versus equivalence clinical trials in assessing biological products.

Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance

BACKGROUND The interpretation of the results of active-control trials regarding the efficacy and safety of a new drug is important for drug registration and following clinical use. It has been suggested that non-inferiority and equivalence studies are not reported with the same quantitative rigor as superiority studies. METHODS Standard methodological criteria for non-inferiority and equivale...

A unifying approach to non-inferiority, equivalence and superiority tests via multiple decision processes.

Two approaches of multiple decision processes are proposed for unifying the non-inferiority, equivalence and superiority tests in a comparative clinical trial for a new drug against an active control. One is a method of confidence set with confidence coefficient 0.95 improving the conventional 0.95 confidence interval in the producer's risk and also the consumer's risk in some cases. It require...

Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension

BACKGROUND Non-inferiority and equivalence trials require tailored methodology and therefore adequate conduct and reporting is an ambitious task. The aim of our review was to assess whether the criteria recommended by the CONSORT extension were followed. METHODS We searched the Medline database and the Cochrane Central Register for reports of randomised non-inferiority and equivalence trials ...