Inclusion Criteria

In Detail

Inclusion criteria are the set of conditions that a person must meet to be eligible to participate in a clinical trial. These criteria are defined in the trial protocol before the study begins and are designed to identify the population most likely to benefit from the treatment while maintaining participant safety. Common inclusion criteria include age range, specific diagnosis or disease stage, biomarker levels, previous treatment history, and general health status. For example, a cancer trial might require participants to have a specific type and stage of cancer, adequate organ function, and a certain performance status. Inclusion criteria serve several purposes. They help ensure that the study population is sufficiently homogeneous so that the treatment's effect can be measured accurately. They also protect participants by ensuring that only people who are reasonably likely to tolerate the treatment are enrolled. However, overly restrictive inclusion criteria have been criticized for limiting the generalizability of trial results — if only narrow populations are studied, it may be unclear whether the treatment works in broader, more diverse groups. The FDA has issued guidance encouraging sponsors to broaden inclusion criteria to improve diversity in clinical trials. At TrialFinder, we translate inclusion criteria from clinical jargon into plain English so patients and caregivers can quickly understand whether they might qualify. Always confirm eligibility with your doctor and the trial's research team.