Incomplete data analysis of non-inferiority clinical trials: Difference between binomial proportions case.

ABSTRACT:

Background

Incomplete data analysis continues to be a major issue for non-inferiority clinical trials. Due to the steadily increasing use of non-inferiority study design, we believe this topic deserves an immediate attention.

Methods

We evaluated the performance of various strategies, including complete case analysis and various imputations techniques for handling incomplete non-inferiority clinical trials when outcome of interest is difference between binomial proportions. Non-inferiority of a new treatment was determined using a fixed margin approach with 95-95% confidence interval method. The methods used to construct the confidence intervals were compared as well and included: Wald, Farrington-Manning and Newcombe methods.

Results

We found that worst-case and best

SUBMITTER: Sidi Y 

PROVIDER: S-EPMC7226649 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature