These criteria define the characteristics a person must meet to be eligible to participate in a trial (inclusion), and which characteristics lead to non-participation (exclusion). They ensure the homogeneity of the study population and are essential for the statistical comparability of the treatment arms as well as for the protection of vulnerable patients.
Defining these criteria is a strategic balancing act: criteria that are too narrow considerably hinder recruitment, while criteria that are too broad increase the variability of the data and can make it harder to demonstrate a significant effect. As part of the feasibility assessment, CROs review the practicability of these criteria against real patient populations.
Strict adherence is monitored by monitors (CRAs) by means of Source Data Verification (SDV). Incorrect inclusions are considered serious protocol violations and can jeopardise the integrity of the entire trial. In modern trials, there is an increasing effort to make the criteria as practice-oriented as possible through Real-World Data (RWD), in order to increase the generalisability of the results.
Mediconomics – für individuelle CRO-Lösungen.
