The Safety Population is used for the analysis of safety, including adverse events, toxicity and laboratory evaluations. A patient should be included if, and only if, they actually received... read more →
The aim of a clinical trial is to make a calculated judgement about the likely clinical effectiveness results that would be seen if the treatments tested were to be... read more →
In a randomised trial, the set of all randomised patients is known as the ‘intention to treat population’, or the ITT population. This clinical trial study population is intended... read more →
The per protocol population, or PP population is usually defined as all patients completing the study without major protocol deviations – that is, those who followed the rules of... read more →