What are inclusion and exclusion criteria?
These criteria specify the eligibility of participants in clinical research. Inclusion criteria set the minimum characteristics required for enrollment, while exclusion criteria list conditions or factors that disqualify participation. These parameters are designed to ensure safety and scientific rigor while addressing the study objectives.
Why are they important in clinical trial design?
Appropriate criteria improve the internal validity of a trial while also influencing its generalizability. They impact patient recruitment, trial efficiency, and regulatory approval. Balancing scientific precision with real-world relevance is key to developing evidence that stakeholders trust.
