Abstract

URANGA, Rolando  and  MIRABAL, Mayelin. Essential elements to consider in non-inferiority studies. Vaccimonitor [online]. 2006, vol.15, n.3, pp.21-24. ISSN 1025-028X.

In some situations, it is usual to compare an experimental vaccine to a standard one without the objective of showing superiority. The common null hypothesis of equality is inappropriate and leads to logical difficulties. The aim of this work is to clarify some issues about this problem, reviewing the methodology developed for these purposes and presenting a value known as non-inferiority limit. Two methods for conducting a hypothesis test of non-inferiority are discussed and two useful concepts: Preservation and Discounting are also introduced.

Keywords : Non-inferiority limit; superiority design; preservation; discounting.

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