Inclusion and exclusion criteria

rdf:langString Inclusion and exclusion criteria

rdf:langString In a clinical trial, the investigators must specify inclusion and exclusion criteria for participation in the study. Inclusion and exclusion criteria define the characteristics that prospective subjects must have if they are to be included in a study. Although there is some unclarity concerning the distinction between the two, the ICH E3 guideline on reporting clinical studies suggests that * Inclusion criteria concern properties of the target population, defining the population to which the study's results should be generalizable. Inclusion criteria may include factors such as type and stage of disease, the subject’s previous treatment history, age, sex, race, ethnicity. * Exclusion criteria concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used for assessment of outcomes), or to eliminate factors that may limit the interpretability of study results (e.g., comorbidities). Exclusion criteria may lead to biases in the study's results.