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Research and new methods

Inclusion and exclusion criteria

Inclusion criteria are what you need in order to join; exclusion criteria are what prevents you from joining. Both are written in the trial plan (protocol).

Last updated: ~1 min read
A clipboard with a checklist next to a pen and a laptop
Figure 1.A list of criteria

01Short answer

Examples of inclusion are a particular type of leukaemia, a particular genetic change, relapse or an age range. Examples of exclusion are serious heart disease, an active infection, certain other medicines or pregnancy. Registries such as ClinicalTrials.gov list these criteria openly, but it is better to read them with your doctor, because the medical terms and numbers can be hard.

02Simple explanation

Inclusion.

Exclusion.

Written in the protocol.

Read them with your doctor.

03Scientific explanation

NCI: eligibility criteria include both inclusion and exclusion conditions.

NCI: new treatments are tested step by step, from the laboratory to clinical trials; only those proven safe and beneficial become standard care.

04What happens in the body?

How to read them

Take the list and your own results to your doctor.

A key
Figure 2.A key — Inclusion and exclusion criteria

Can they change

Criteria can change when the protocol is updated.

A measure
Figure 3.A measure — Inclusion and exclusion criteria

How to read the news

Research news brings hope, but not every advance suits everyone. Look at who it was tested in, at what phase and in how many people.

Talk to your doctor

Show your doctor what you have read; they will explain how it relates to your diagnosis and treatment. Do not change your treatment on your own.

05From research news to a conversation: four steps

Read, check, ask, decide together.

Read — From a trusted source.1ReadFrom a trusted source.
Check — Phase, participants, result.2CheckPhase, participants, result.
Ask — Show your doctor.3AskShow your doctor.
Decide — Together, without rushing.4DecideTogether, without rushing.
SourceA trusted site.
DoctorA personal explanation.
SafetyNot changing treatment yourself.

06Key points at a glance

TopicIn brief
How to read themTake the list and your own results to your doctor.
Can they changeCriteria can change when the protocol is updated.
How to read the newsResearch news brings hope, but not every advance suits everyone. Look at who it was tested in, at what phase and in how many people.
Talk to your doctorShow your doctor what you have read; they will explain how it relates to your diagnosis and treatment. Do not change your treatment on your own.

07Key terms

Inclusion criterion
A requirement for joining.
Exclusion criterion
A barrier to joining.
Clinical trial
Testing a new treatment with volunteers.
Evidence
A result confirmed by reliable research.

08Key points

  • Learn.
  • Ask your doctor.
  • Write it down.
  • Check the source.
  • Talk to your doctor.

09Frequently asked questions

What if I miss one criterion?

Usually you cannot join, but another trial may fit.

Why are the criteria so strict?

For safety and clear results.

Is this advance right for me?

Only your treating doctor can say, based on your diagnosis, stage and condition.

10Questions for your doctor

Take these questions to your appointment. The ones you save are collected on the “My questions” page and stay on this device only.

  1. What if I miss one criterion?

  2. Why are the criteria so strict?

  3. Is this advance right for me?

My questions

12Sources

  1. National Cancer Institute. NCI Dictionary of Cancer Terms: eligibility criteria
  2. National Cancer Institute. What Are Clinical Trials?
  3. U.S. National Library of Medicine. ClinicalTrials.gov
  4. National Cancer Institute. Phases of Clinical Trials
  5. National Cancer Institute. Using Trusted Resources
  6. National Cancer Institute (NCI). Paying for Clinical Trials
  7. National Cancer Institute (NCI). Find NCI-Supported Clinical Trials
  8. Cancer.Net (ASCO). Phases of Clinical Trials
  9. Cancer.Net (ASCO). Placebos in Cancer Clinical Trials
  10. Cancer.Net (ASCO). Questions to Ask About Clinical Trials
Medical disclaimerThis information is for educational purposes only and does not replace medical advice.
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