Why Should I Participate in a Clinical Trial?

May 2009

If you or someone you know has been diagnosed with cancer, a clinical trial might be a treatment option.

Clinical trials are research studies for people. Cancer clinical trials work to find new and better ways to prevent, find and diagnose or treat cancer. Trials may also look at ways to cope with side effects of cancer or treatment.

Cancer clinical trials test new medicines, vaccines, surgical or radiation treatments. Medicines that are already used for one type of cancer may be studied to see if they can treat other types of cancer. And often trials work to identify which medicines work best together to treat certain cancers.

For a type of treatment to become accepted as a standard, the treatment must go through three or four levels of clinical trials. These levels are called “phases”. Early phases will make sure the treatment is safe. Later phases will look to see if the new treatment is better than the current accepted standard treatment for that cancer type.

Phase I trials look at what a safe dose of the treatment would be or how it should be given to the patient. This phase also looks to see how the treatment affects the body.

Phase II trials seek to find out if the new treatment affects the cancer cells. This phase also looks to see if the new treatment causes side effects.

Phase III compares the new treatment to the current accepted standard treatment that is used with most patients.

Phase IV will follow patients over time to see how well the treatment works. This phase also watches for long-term side effects.

As a patient you are never required to be in a clinical trial. Each patient must make that choice for themselves. You may also never be included in a trial without your permission. This is called informed consent.

If you chose to take part in a trial, at any point in time you can decide to stop participating. If you chose to stop taking part in the trial, your doctor will talk with you about your other treatment options. You will never be denied treatment for your cancer because you did or did not take part in a clinical trial.

Cancer clinical trials give patients access to high quality of care. Placebos are almost never used in cancer clinical trials. You will always be told if a study you are thinking about joining may use a placebo.

It is important to remember most trials compare a new treatment against the best accepted standard treatment. The new treatment being studied may work as well as, or better than, the current standard treatment.