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Research and new methods

What is a clinical trial: safe testing with volunteers

A clinical trial tests a new treatment, test or approach in volunteers, following a precise plan called a protocol. It shows whether the new option is better than, as good as or less harmful than standard treatment.

Last updated: ~1 min read
A clinician taking notes on a clipboard while talking with a seated volunteer
Figure 1.A conversation with the study team

01Short answer

Every trial has a written protocol: who can take part, what is given, which tests are done and when. An ethics committee and the regulator approve it in advance, and participants' safety is monitored throughout. Participants give informed consent and can leave at any time. In leukaemia, many trials add a new medicine to standard treatment, so no one goes untreated. A trial is both an opportunity and a commitment: there may be extra visits and tests.

02Simple explanation

A precise protocol.

Ethics oversight.

Voluntary consent.

Leave at any time.

03Scientific explanation

NCI: clinical trials study whether new treatments are safe and effective, and they can be an option for people with cancer.

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?

Types

Treatment, prevention, diagnosis and quality-of-life trials.

Four steps
Figure 2.Four steps — What is a clinical trial: safe testing with volunteers

Standard treatment

The best current treatment, used for comparison.

A protective shield
Figure 3.A protective shield.

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
TypesTreatment, prevention, diagnosis and quality-of-life trials.
Standard treatmentThe best current treatment, used for comparison.
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

Protocol
The written plan of a trial.
Informed consent
Voluntary agreement after a full explanation.
Clinical trial
Testing a new treatment with volunteers.
Evidence
A result confirmed by reliable research.

08Key points

  • Read.
  • Ask.
  • Decide.
  • Check the source.
  • Talk to your doctor.

09Frequently asked questions

Will I be a guinea pig?

No; trials are protected by strict rules and your rights are kept.

Do I have to pay?

Often the sponsor covers trial costs; ask for details.

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. Will I be a guinea pig?

  2. Do I have to pay?

  3. Is this advance right for me?

My questions

12Sources

  1. National Cancer Institute. What Are Clinical Trials?
  2. National Cancer Institute. Informed Consent in Clinical Trials
  3. National Cancer Institute. NCI Dictionary of Cancer Terms: clinical trial
  4. National Cancer Institute. Phases of Clinical Trials
  5. National Cancer Institute. Using Trusted Resources
  6. U.S. Food and Drug Administration (FDA). Step 3: Clinical Research
  7. U.S. Food and Drug Administration (FDA). Learn About Expanded Access and Other Treatment Options
  8. European Union. Clinical Trials Information System (CTIS) — public search
  9. World Health Organization (WHO). International Clinical Trials Registry Platform (ICTRP)
  10. National Cancer Institute. NCI Dictionary of Cancer Terms: phase I clinical trial
Medical disclaimerThis information is for educational purposes only and does not replace medical advice.
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