Multiplicity Issues in Clinical Trials

In clinical trials, more than one endpoint is generally analyzed. There may be two or more co-primary endpoints, or a number of secondary endpoints for which specific claims are defined. The classical statistical approach (frequentist) has limitations, methods for controlling the overall alpha level (study wise level of significance) should be implemented.

In this session, we shall present and explain the problem of multiplicity and the statistical limitations, and then discuss various methods to remedy to this problem along with their “cost” in terms of statistical penalty.