Before any clinical trial or other research study begins, researchers develop the protocol for that study. This detailed plan describes the study’s design, the reasons for doing the study, and who can join (known as the eligibility criteria).
Eligibility criteria
Before any clinical trial or other research study begins, researchers develop the protocol for that study. This detailed plan describes the study’s design, the reasons for doing the study, and who can join (known as the eligibility criteria).
The eligibility criteria are the rules for who can take part in the research study. They outline the features that must be shared by all participants to ensure that the people taking part are similar in certain ways. This is so the results of the study will be clearly related to the treatment, not to other individual factors.
Depending on the research, the eligibility criteria may include:
- age or sex
- cancer type
- stage of the cancer
- symptoms or side effects experienced
- length of time since diagnosis or treatment
- previous treatments for the cancer
- other medical conditions.
Eligibility criteria can be broken down into:
- inclusion criteria – the features a person needs to have to join a research study
- exclusion criteria – the features that stop someone from taking part.
The eligibility criteria also help keep people safe by considering things that might make the trial too risky for them. For example, you may be excluded from a trial if you are pregnant, have high blood pressure, or have some other condition that increases the risks of the treatment.
Although there are thousands of different clinical trials occurring around the world at any one time, eligibility requirements can be very specific, and there may not be a trial suitable for your particular situation. For example, if you have metastatic cancer, the disease may have to be active or progressing for you to be eligible to join a particular trial.
Video: What is a clinical trial?
In this video, Medical Oncologist Dr Elizabeth Hovey explains what clinical trials are and how they can improve cancer treatment.
Podcast: Making Treatment Decisions
Listen to more episodes from our podcast for people affected by cancer
Key resource
Download a PDF booklet on this topic.
More resources
All updated content has been clinically reviewed by A/Prof Brett Hughes, Senior Staff Specialist, Medical Oncology, Royal Brisbane and Women’s Hospital and The Prince Charles Hospital, and Associate Professor, The University of Queensland, QLD. This edition is based on the previous edition which was reviewed by the following panel: A/Prof Brett Hughes (see above); Christie Allan, Clinical Trials Lead, Cancer Council Victoria, VIC; Dawn Bedwell, 13 11 20 Consultant, Cancer Council Queensland, QLD; Joanne Benhamu, Senior Research Nurse, Team Lead, Lung, Colorectal and Palliative Care Trials, Parkville Cancer Clinical Trials Unit, Peter MacCallum Cancer Centre, VIC; Louise Dillon, Consumer; Sabina Jelinek, Clinical Nurse Research, St John of God Murdoch Hospital, WA; Chloe Jennett, Program Coodinator, Cancer Research, Cancer Council NSW; Carmel McCarthy, Consumer; Alison Richards, Research Unit Manager, Medical Oncology Clinical Trials Unit, Flinders Medical Centre, SA; Prof Jane Ussher, Translational Health Research Institute (THRI), School of Medicine, Western Sydney University, NSW; Prof Janette Vardy, Medical Oncologist, Concord Cancer Centre, and Professor of Cancer Medicine, The University of Sydney, NSW.
View the Cancer Council NSW editorial policy.
