Sample Size Estimation for Non-Inferiority Trials: Frequentist Approach versus Decision Theory Approach.

ABSTRACT:

Background

Non-inferiority trials are performed when the main therapeutic effect of the new therapy is expected to be not unacceptably worse than that of the standard therapy, and the new therapy is expected to have advantages over the standard therapy in costs or other (health) consequences. These advantages however are not included in the classic frequentist approach of sample size calculation for non-inferiority trials. In contrast, the decision theory approach of sample size calculation does include these factors. The objective of this study is to compare the conceptual and practical aspects of the frequentist approach and decision theory approach of sample size calculation for non-inferiority trials, thereby demonstrating that the decision theory approach is more appropriate f

SUBMITTER: Bouman AC 

PROVIDER: S-EPMC4468148 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature