Including all individuals is not enough: Lessons for intention-to-treat analysis

Abstract

Clinical trials should employ an ITT analysis strategy, comprising a design that attempts to follow up all randomised individuals, a main analysis that is valid under a stated plausible assumption about the missing data, and sensitivity analyses that include all randomised individuals in order to explore the impact of departures from the assumption underlying the main analysis. Following this strategy recognises the extra uncertainty arising from missing outcomes and increases the incentive for researchers to minimise the extent of missing data.