Some remaining challenges regarding multiple endpoints in clinical trials.

Despite recent advance in methods for handling multiple endpoints in clinical trials, some challenges remain. This paper discusses some of these challenges, including confusion surrounding the terminology used to describe the multiple endpoints, the justification for simultaneously testing for non-inferiority and superiority in a non-inferiority trial, lack of agreement on the situations under which multiple objectives do or do not lead to the need for a multiplicity correction, and choice of the most appropriate multiple comparisons procedure. In addition, this paper will discuss the position of the recent FDA draft guidance, Multiple Endpoints in Clinical Trials, on these issues.