Outcome Definition Clinical Trial. The primary outcome needs to be defined at the time the study is designed. Primary outcomes are the most important outcomes of the study the ones that determine its design and the study size.
Types of COAs include. In the above trial the primary outcome was prevalence of diarrhoea. An outcome measure is the result of a treatment or intervention that is used to objectively determine the baseline function of a patient at the beginning of the clinical trial.
These three outcomes are considered surrogate end-points by the CF research community and regulatory agencies as improvements in these parameters are likely to predict clinical benefit.
A clinical outcome assessment is a measure that describes or reflects how a patient feels functions or survives. Surrogates Often a biomarker that is intended as a substitute for how a patient feels. In the above trial the primary outcome was prevalence of diarrhoea. Once the treatment or intervention has commenced the same instrument can be used to determine progress and efficacy.