From OncoLog, February 2012, Vol. 57, No. 2
House Call: Clinical Trials
Understanding the risks, benefits, and purpose of a trial can help cancer patients decide whether to participate
Clinical trials of possible new cancer treatments are a source of hope, and sometimes confusion, for cancer patients and their families. Here are a few facts to help you decide whether you want to take part in a clinical trial.
Clinical trials are research studies aimed at finding better ways to prevent, diagnose, or treat cancer. Although this article will focus on trials of drugs for cancer treatment, trials for all three purposes are conducted in a similar fashion.
Long before a clinical trial can be considered, researchers must investigate a new drug in a lengthy series of laboratory and animal studies, usually over several years. If the results are promising, physicians proceed to studying the treatment in people.
The federal government sets strict rules that doctors must follow when designing clinical trials and determining the criteria for who may join each trial. Eligibility criteria may include such factors as patients’ cancer type and stage, previous cancer treatments, overall health, age, sex, and any medicines being taken for other conditions.
A physician may offer a patient a clinical trial as a treatment option when standard treatments have limited benefit or when a patient’s disease has not responded to or becomes resistant to previous therapy. If you are a patient and find a trial you would like to consider, you should talk to your doctor to determine whether you are eligible.
Get the facts
You can learn more during a process called informed consent, when the physician or research nurse explains the clinical trial’s purpose, plan, risks, and possible benefits. This is the time to ask as many questions as you need to ask until the answers are clear to you. These are some of the questions you might want to ask:
What are my treatment options? Find out the standard treatment for your type of cancer—or other treatments if you have already had the standard treatment—and what treatment will be given in this clinical trial.
What is my prognosis? Your prognosis is what may happen with your cancer and how your cancer might respond to treatment. How might the clinical trial affect your prognosis? How might other treatment options affect it?
What phase is this clinical trial? Phase I trials test whether a new treatment is safe, the doses at which it can be safely given, the best way to deliver the treatment, and if and how patients’ cancers respond to the treatment. Usually only a few patients take part in a phase I trial.
Phase II trials usually involve fewer than 100 patients and study how one type of cancer responds to the new treatment. Phase II trials often compare different doses or treatment schedules to determine which should be used in a phase III trial.
Phase III trials, which can include hundreds or thousands of patients, test whether a new treatment is better than a standard treatment. Whether each patient gets the new treatment or the standard treatment is determined randomly (as if by the flip of a coin).
Think it over
Each clinical trial has potential benefits and risks. The main advantage of participating is that you will have access to promising new interventions that are often not available to the general public. If the new treatment works, you may be among the first to benefit from it.
Other benefits of a clinical trial are that you will receive regular and careful medical attention from a research team of doctors, nurses, and other health professionals. Finally, the results of the trial may help future cancer patients.
One of the key risks of participating in a clinical trial is the possibility of unexpected side effects that could be worse than those of the standard treatment. New treatments do not always turn out to be better than, or as good as, standard treatments. It is also possible that the new treatment might not work for you even if it does for other patients.
Take some time to make your decision about whether to participate in a trial. If you wish, you can take home the written informed consent document to review before signing it. This document explains the treatment in detail, the types of medical tests patients receive, who pays for the costs of the clinical trial, and who to call if you have more questions.
– K. Stuyck
For more information, talk to your physician, visit www.mdanderson.org, or call askMDAnderson at 877-632-6789.