What are cancer clinical trials?
Cancer clinical trials are research studies designed to find new or better ways to prevent, diagnose, or treat cancer.
What are the different types of clinical trials?
There are several types of trials.
- Screening trials test the best ways to find cancer, especially in its early stages.
- Prevention trials test new ways to lower the risk of getting cancer, such as medicines; vitamins, minerals, or other supplements; or diet and behavior changes, such as exercise.
Treatment trials test:
- New approaches to surgery or radiation therapy
- New cancer drugs
- New combinations of treatments
- New kinds of therapy, such as gene therapy
- Quality-of-life trials explore ways to improve comfort and quality of life for people who have cancer. These studies are important because many people live with cancer for years after their diagnosis. These studies are also called supportive care trials.
How do clinical trials of a new drug work?
Most research that involves the testing of a new drug has 3 phases:
Phase 1 trials usually enroll just a small number of people. Phase 1 trials test:
- Different ways to take a new drug (for example, by mouth or injection)
- Different dosages
- The side effects of the drug
- Phase 2 trials test the safety of a drug and how well the new drug works.
- Phase 3 trials compare a new drug with a current drug used for treatment. You will be assigned to either the group receiving the standard treatment or the group receiving the new treatment. Phase 3 trials may be done through doctors' offices, clinics, or at cancer centers nationwide.
An important thing to know about cancer clinical trials is that they do not use placebos. Placebos are pills or injections that do not contain any medicine. Sometimes people worry that taking part in a cancer clinical trial will mean that they will not be given any treatment. In cancer research, new drugs and treatments are compared with known treatments, not with a lack of treatment.
What happens during a trial?
If you decide to take part in a trial, you will work with a research team. Team members may be healthcare providers, social workers, pharmacists, and other professionals. They will give you instructions about the study, provide your care, and check your health during the study.
Taking part in a trial may mean that you have more tests and doctor visits than you would if you were not in the study. To make the trial results as reliable as possible, you must follow the research team's instructions. That means carefully following the schedule for all doctor visits and tests, taking medicines exactly as directed, and filling out logs or questionnaires.
What are possible risks and benefits of clinical trials?
Some of the possible benefits are:
- You may get healthcare from leading doctors in the field of cancer research, including experts on your type of cancer.
- You may be able to get new treatments before they are widely available.
- You will have a chance to make a valuable contribution to cancer research.
Possible risks include:
- New drugs and procedures may have unknown side effects or risks.
- New drugs and procedures may not help, or they may not work as well as other treatments.
- Even if a new treatment has benefits, it may not work for you.
During the trial, review committees make sure that people who take part in clinical trials are protected from any unusual risks or side effects.
Researchers must tell you about a study's treatments, tests, and possible benefits and risks before you decide to join the trial. This process is called informed consent.
What happens when a clinical trial is over?
After a phase 1 or phase 2 trial is completed, the researchers look carefully at the data collected during the trial and decide whether to:
- Move on to the next testing phase with the treatment, or
- Stop testing the treatment because it is not safe or not effective.
In most cases, the results of trials are published in scientific or medical journals.
Can I take part in a clinical trial?
Each clinical trial has guidelines for who can take part, called eligibility criteria. Eligibility criteria for a treatment trial might be:
- Having a certain type and stage of cancer
- Age or gender
- Previous treatments you have had
To find out if you can take part in a certain clinical trial, talk to your healthcare provider or the provider in charge of enrolling people in the trial.
Should I take part in a clinical trial?
Only you can decide to take part in a clinical trial. Before you make your decision:
- Learn as much as you can about your disease and the clinical trials that are available.
- Talk with your healthcare provider, family members, and friends. When you talk with your healthcare provider, some of the questions you may want to ask are:
- What is the purpose of the trial?
- What tests and treatments are involved?
- How long will I be involved with the study?
- What side effects can I expect?
- How will the side effects be managed?
- What costs will I have to pay myself?
- What happens if I want to stop being in the study?
- Will taking part in the clinical trial decrease or increase my chance of survival?
For more information, contact:
- American Cancer Society, Inc.800-227-2345http://www.cancer.org
- National Cancer Institute800-422-6237 (TTY: 800-332-8615) http://www.cancer.gov
- National Institutes of Health http://clinicaltrials.gov/
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