Demonstrating non-inferiority in clinical trials is usually more challenging than showing superiority. In multiple sclerosis (MS), non-inferiority trials are rarely designed since they would require prohibitive sample sizes. In this brief report, the reasons why non-inferiority trials are usually larger than superiority trials is explored.
VermerschPCzlonkowskaAGrimaldiLM. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: A randomised, controlled phase 3 trial. Mult Scler2014; 20: 705–716.
