ABSTRACT
This chapter highlights how clinical trial studies are designed so that they have multiple outcomes for the assessment of the treatment effect. Multiplicity in the outcomes in a trial increases either the Type I or the Type II error. This chapter discusses multiplicity in terms of the demonstration of statistically significant results in favour of the experimental treatment and controlling the error rates in the trial in this context.
It is highlighted how in reality, these trials may have superiority objectives for each outcome, or they may have non-inferiority or equivalence type objectives or even a mixture of objectives depending on the outcome.
