What are eligibility criteria?
Eligibility criteria are the specific characteristics required—or disallowed—for participation in a clinical trial. These include demographic factors, disease characteristics, comorbidities, prior treatments, and laboratory values. Inclusion criteria define who can participate, while exclusion criteria outline who must be left out for safety or scientific validity.
Why are eligibility criteria important in clinical trials?
Well-designed eligibility criteria ensure the trial population is appropriate for assessing the treatment’s effects, while also protecting participant safety. They affect recruitment feasibility, generalizability, and the regulatory and payer perception of the evidence. Overly narrow criteria can limit real-world relevance, while overly broad criteria may increase risk or data variability.
