What is a Clinical Trial?

Clinical trials help to find new methods for diagnosing, treating, managing and preventing cancer. They examine a broad range of areas:

• new anti-cancer drugs, including chemotherapy, hormonal therapy, biological therapy and immunotherapy agents
• new approaches to cancer prevention, screening, surgery and radiation therapy
• new combinations of treatments
• new ways of using standard treatments
• complementary and alternative cancer therapies
• supportive care to reduce the impact of cancer on emotions and behaviour

If the new method or treatment is found to be safe and effective in clinical trials, then it can be made available to the public. Through past clinical trials, doctors have developed new methods of surgery that are less invasive. Scientists have also developed new drugs that are more effective for specific types of cancer, or that have fewer side effects. Even the most promising scientific findings must first be proven to be safe and effective in clinical trials before they can be used as standard treatment. The cancer treatments that are used today were developed and tested in clinical trials.

Deciding whether to take part in a clinical trial

Clinical trials give people with cancer access to the newest types of treatment. By taking part in a clinical trial, you could be among the first to benefit from a new treatment. Although there is no guarantee of the outcome, the treatment being tested may prove to be as effective, or more effective, than the standard treatment available for your cancer at this time.

Most people who take part in clinical trials do so for personal reasons. They may want a chance to feel better or even to live longer. Other participants feel satisfied from knowing they may be helping others with cancer, both now and in the future.

The most important aspect of a clinical trial is the protection of patient safety. That's why researchers who are conducting clinical trials for new or potentially better cancer treatments must agree to follow strict procedures and follow ethical standards. These standards are aimed first and foremost at protecting the health and privacy of patients in a clinical trial.

Before deciding whether a clinical trial is an option for you or someone you care about, it's important to learn all you can. And remember: while a clinical trial may be a good choice for one person with cancer, it may not be suitable for someone else.

Your rights and protections

Clinical trials follow very strict ethical standards that protect the patient's health, safety and privacy. Each clinical trial involving a new therapy or new ways of delivering an existing treatment must be approved by Health Canada, the hospital or clinic where the study takes place, and its research ethics board - a committee of health professionals and individuals from the community. These groups continue to monitor the trial until it is completed.

You have the right:

• To be given all the facts about a clinical trial before deciding to take part. This important process is known as informed consent. You will receive a printed consent form that outlines key facts about the study. These include details about the treatments, tests and any potential benefits, risks or side effects. If you agree to take part in the study, you will be asked to sign the informed consent form.
• To be monitored carefully during the study in case you have a bad reaction to the new treatment.
• To take part in the clinical trial voluntarily. You may leave the trial at any time. If you choose to leave the trial you will continue to receive the best treatment possible

What happens in a cancer clinical trial?

If you decide to join a Phase III cancer trial, you'll work with an experienced research team that includes doctors, nurses and other health care providers. They will give you clear instructions.

During the study, your research team will review your health carefully. This means that you may have more tests and doctor visits than you would if you weren't in the study. Team members also may check on you for a while after the trial ends (follow-up). To make the trial results as reliable as possible, it is important for you to follow the research team's instructions. Careful review and follow-up help you and scientists find out quickly what treatment is best.

Who can participate?

Clinical trials try to enroll people who are alike in certain ways, depending on the study's purpose. Every protocol tells who can join that study and spells out the characteristics that people should have. These are called eligibility criteria or inclusion and exclusion criteria. They may include age, gender, general health and cancer risk factors.

Eligibility criteria are a key part of medical research. They help produce results we can trust. After those results are known, the information can help doctors find out who will be helped by the approach being studied if it's shown to work. For example, a new drug may work for people with one type of risk factor but not for another, or it may work better for men than for women.

Eligibility criteria also help protect you. They help make sure that if you are likely to be harmed by something in the study design, you are not exposed to that risk.

No one knows whether it is better to be in the intervention or control group until the study is over and the results are ready. If that were known, there would be no need for the study. Either group may have good results or problems. The results help doctors decide whether to advise people to take one treatment approach or another.