More cancer treatments are available today than ever before. These therapies wouldn’t exist without the countless cancer patients who volunteer to participate in clinical trials.
Clinical trials are research studies in which real people test new drugs or treatments. These trials tell doctors and scientists whether a new treatment is safe and effective. The Food and Drug Administration (FDA) sets strict safety rules for clinical trials. The FDA also reviews clinical trial results before allowing any new drug or medical device to be used or sold in the United States.
Doctors at UPMC Hillman Cancer Center believe clinical trials play a crucial role in improving cancer care for everyone.
Below are answers to some common questions cancer patients have about clinical trials.
How are patients selected for clinical trials?
First, you need to find a clinical trial that’s testing a treatment or procedure for the type of cancer you have. Your doctor may ask if you want to enroll in a study. You also can find research studies on ClinicalTrials.gov, a global database of privately and publicly funded clinical studies. A support group for your disease also may offer information about clinical trials.
Just because you have the disease researchers are studying doesn’t mean you will qualify to take part in the trial. Researchers follow strict rules to determine who can participate in order to best answer the question the study is asking.
For example, cancer researchers might require that patients have:
- A specific stage of cancer
- A specific tumor size or location
- A specific genetic mutation in the tumor
- Cancer that’s spread to a certain body part
- Good overall health to lessen the risk of harm
For research to succeed, researchers need people of both sexes and all ages, races, and ethnic groups.
How will I benefit from participating in a clinical trial?
There are no clear answers to this question. But participating in research helps you take charge of your medical care. BreastCancer.org notes that taking part in a clinical trial might give you a sense of control in your life. In turn, you may develop a more positive outlook, which is important in cancer care outcomes.
Top-notch medical care and free or low-cost medical care may come with the clinical trial. Knowing that you may help others receive better treatment for their cancer in the future can feel great, too.
Taking part in a clinical trial also means you may get access to a new treatment before it is available to everyone. And sometimes the drug or treatment being tested may be more effective — or create fewer side effects — than your current treatment plan.
However, it’s important to understand that you won’t be able to choose which treatment you get. In randomized trials, you are randomly assigned to get a specific treatment. In some trials, you may be assigned to get a drug-free placebo.
Are there risks to participating in a clinical trial?
Every study builds in patient protections, but there is always a risk involved when participating in research. According to the National Institutes of Health, common risks of clinical trials include:
- Potential inconvenience if the trial requires many medical visits
- Side effects, some of which may be serious
- No improvement over existing treatments (in which case you could leave the trial and go back to your previous treatment)
- The uncertainty of not knowing whether you receive the new treatment or the standard treatment depending on the trial’s format
Before you take part in any research, your doctor or another member of the research team will tell you about the major risks. They will also answer your questions in detail. Once you understand everything and agree to take part in the trial, you will sign an “informed consent” document.
Do research participants get paid?
You may receive some money for taking part in a clinical trial. Generally, it is a small amount to cover related expenses like transportation or parking. You may also receive an allowance for meals or childcare.
What happens if I change my mind about participating in a clinical trial?
You have the right to drop out of a clinical trial at any time, even after the study starts. Talk to your doctor about any concerns. Your doctor can help you decide if it is in your best interest to continue in the trial or withdraw. If you decide to withdraw, your regular medical care at UPMC will not change.
For more information about clinical trials at UPMC Hillman Cancer Center, go to Hillman.UPMC.com/research/clinical-trials.
Sources
U.S. Food and Drug Administration. Clinical Trials and Human Subject Protection. Link
National Institute on Aging, National Institutes of Health. Clinical Trials: Benefits, Risks, and Safety. Link
ClinicalTrials.gov. National Library of Medicine. Link
BreastCancer.org. Benefits and Risks of Participating in a Clinical Trial. Link