Every clinical trial has a list of inclusion and exclusion criteria – together called eligibility criteria – that outline who can and cannot participate in that trial. These criteria are necessary because they allow researchers to more accurately determine if a new treatment is safe and effective by ruling out certain factors that may affect research results. Each clinical trial summary on Metastatic Trial Search includes an overview of the main criteria in the section called “Who is This For?” and a link to the full inclusion and exclusion criteria for that trial.
However, criteria that are too restrictive can limit who can participate in a trial. Restrictive criteria may result in the trial not fully representing real-life patients who will receive the experimental drug, if it is approved. Restrictive criteria can also make it difficult to determine whether the drug will benefit and be safe in people who do not meet the criteria. For this reason, groups like Friends of Cancer Research are working with the US Food and Drug Administration (FDA) to provide recommendations for eligibility criteria that will allow more patients to participate in trials and ensure that the results will apply to the patients who are expected to receive the medication after approval.
Click the links below to learn about what inclusion and exclusion criteria are and the efforts to optimize them.
What are Inclusion and Exclusion Criteria for Clinical Trials?
- University of California, San Francisco: Inclusion criteria describe who can participate, and exclusion criteria describe who cannot participate in a clinical trial
- Scribbr: This article provides definitions and examples of inclusion and exclusion criteria for research studies
Optimizing Inclusion and Exclusion Criteria
- Friends of Cancer Research: Friends of Cancer Research and the American Society of Clinical Oncology (ASCO) have worked together to provide recommendations to the FDA about clinical trial criteria such as washout periods, brain metastases, and others
- National Cancer Institute (NCI): The NCI has contributed to expanding eligibility criteria by providing wording that researchers can use when planning clinical trials
- FDA: The FDA explains inclusion and exclusion criteria and how they may need to be revised
- Duke University (slides and video): This conference covered the reasons to expand eligibility criteria
- eCancer (video): Dr. Jorge Nieva describes a study that examines expansion of eligibility criteria
Last Modified on March 3, 2025