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What Is a Clinical Trial?
What Is a Clinical Trial Protocol?
Where are Trials Conducted?
Who Can Participate in a Trial?
How Are Trial Participants Protected?
Risks and Benefits of Participating in Clinical Trials.
What Happens in a Clinical Trial?
What is Informed Consent?

What Is a Clinical Trial?

Clinical trials are studies (or protocols) that evaluate the safety and effectiveness of new interventions (treatments, procedures, and methods). Different types of cancer clinical trials include:

• Prevention trials designed to keep cancer from developing in people;
• Early detection trials to find cancer, especially in its early stages;
• Treatment trials to test new therapies in people who have cancer;
• Quality of life studies to improve comfort and quality of life for people who have cancer;
• Studies to evaluate ways of changing cancer-causing behaviors, such as tobacco use.

If you take part in a clinical trial, you may benefit from a new drug, procedure, or symptom-control method. You may also contribute directly to finding better ways to prevent, detect, or treat the disease. Many of today's most effective interventions are the direct result of knowledge gained through clinical trials.

What Is a Clinical Trial Protocol?

• Every trial has a chief investigator, who is usually a doctor. The protocol is a plan that explains what the trial will do, how, and why.

Where are Trials Conducted?

• If you were to participate in a clinical trial, you might receive your first treatment at a large cancer center, a university hospital, or your local medical center or physician's office.

Who Can Participate in a Trial?

• Every protocol identifies some specific characteristics that the people should have in order to participate in the study. These are called eligibility criteria. They may include the type of disease and extent of disease, age and general health.
• Eligibility criteria help assure that the study results answer the research question. They also tell doctors who will benefit in the future from the approach being studied if it is shown to work.

How Are Trial Participants Protected?

• One or more review groups have to approve every protocol. Two of those groups are the organization that sponsors it (such as, the National Cancer Institute) and the local Institutional Review Board(IRB) that oversees clinical research in the health-care institution.
• Every study center has an IRB (such as, the University of Arizona), which includes doctors, other health care providers, consumers, and sometimes members of the clergy. The IRB ensures that the study is conducted fairly and that study participants are not likely to be harmed.

Risks and Benefits of Participating in Clinical Trials

As you weigh the risks and benefits of clinical trial participation, you may want to consider the following:

The potential benefits include:
• Health care provided by leading physicians in the field of cancer research
• Access to new drugs and interventions before they are widely available
• Close monitoring of your health care and any side effects
• A more active role in your own health care

The potential risks include:
• New drugs and procedures may have side effects or risks unknown to the doctors
• Even if a new approach has benefits, it may not work for you
• Health insurance does not always cover all the care costs in a clinical trial

Discussions with your doctor, nurse, family, and friends combined with knowledge from cancer information sources will help you make better decisions about your healthcare options.

What Happens in a Clinical Trial?

• A research team that may include doctors, nurses, social workers, and other health care providers will provide your care, monitor your health carefully and give you specific instructions about the study.
• You might have more tests and doctor visits than you would if you were not in the study.
• Team members may continue to stay in contact with you after the trial ends.
• It is important to follow the research team's instructions. That means having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.

What is Informed Consent?

• Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. These facts include details about the study approach, the intervention given, the possible risks and benefits, and the tests you may have.
• The research doctor, nurse, or a study coordinator will give you written information called a consent form that goes over key facts.
• Even if you agree to participate in a clinical trial and sign an informed consent, you are free to withdraw from the trial at any time and discuss other therapy with your doctor.

Other Resources

• The information above was taken from the National Cancer institute (NCI) website. It has been modified for use at our site. the complete version can be found at: http://cancertrials.nci.nih.gov
• You can also call the NCI at 1-800-4-CANCER.
• The Arizona Cancer Center Patient Education Room has educational videos and reading materials.