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Clinical trials are research studies that involve people. They are used to test new treatments, find new ways to diagnose disease, and even learn ways to prevent disease. Cancer clinical trials are how scientists can improve cancer care and outcomes.

Clinical trials aren’t for everyone. Most have strict criteria for who can enter. But many people not only benefit themselves by joining a trial, but they also advance our overall understanding of cancer. That improves future care for everyone.

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Cancer Clinical Trials FAQs

Misunderstanding and a little fear still surround clinical trials. So let’s look at a few common questions about these research studies.

What do the different clinical trial phases mean?

Clinical trials are phase I, phase II, or phase III. Before a treatment gets into a clinical trial it goes through preclinical testing. During this phase, researchers test the drug on cells or animals to determine if it’s safe enough to go into human trials.

In a phase I trial, the researchers are trying to figure out the safest dose of treatment. They also look at what side effects the treatment may cause. A small number of people participate in phase I trials.

Phase II trials enroll more people. These studies look at how a treatment affects the body and try to better understand how the treatment works.

Phase III trials enroll much more people, often hundreds or even thousands. Phase III trials compare the new treatment to the existing treatment. This helps researchers evaluate if the new treatment offers improvement over the existing treatment.

What are the benefits of joining a clinical trial?

One of the main benefits is you get access to the latest treatments. These may work better than the current standard of care. You also help advance our understanding of cancer. This leads to better treatment for people going forward.

The study team closely monitors you during a trial. So you may get more attention from your care team when participating in a trial. In addition, some clinical trials may cover a portion of your medical costs. This varies by trial, so be sure to ask about what’s paid for and by whom before you enroll.

Are clinical trials safe?

While the FDA has authority over all trials, each trial has an Institutional Review Board (IRB) that approves its particular protocol. The IRB is made up of doctors and scientists. This review board makes sure the study process is safe for those participating.

While researchers and reviewers take all precautions to ensure your safety, trials aren’t without risks. All treatments carry a chance of causing negative effects. In a cancer clinical trial, you will receive a new treatment with some unknowns. It may have side effects that are different or even worse than the standard treatment. Earlier phase trials have more unknowns and may carry higher risks.

Talk through your concerns with your doctor to decide whether the risks outweigh the benefits.

What does the trial pay for?

Clinical trials may cover some of your cancer care costs. But you should ask for details before participating. Often, you still pay for costs related to standard treatment, such as routine doctor visits or hospital stays. These are usually already covered by your insurance.

The trial may cover research costs. This includes the drug or intervention being tested, additional tests, and sometimes travel costs. Before you participate in a trial, you need to sign an informed consent document. This document explains the trial procedure and what costs are covered. If it’s unclear, ask questions until you have all the answers you need.

Are clinical trials a last resort for people with cancer?

No. It’s a common misconception that trials are a last option for people who haven’t responded to other treatments. Cancer clinical trials are open to people at various stages and for many types of cancer. Some trials also look for better ways to diagnose cancer, to prevent cancer, or to manage side effects.

How do I find out what clinical trials are available in my area for my cancer type?

Cancer centers and medical centers across the country conduct trials. First, talk to your doctor about whether you may be eligible for any trials in your area. You can also search clinicaltrials.gov. This database lists trials across the country. Each trial has specific criteria to decide who can join.

Choosing to participate in a cancer clinical trial can be a difficult decision. Carefully talk through the risks and benefits with your care team.

Sources

National Cancer Institute. Clinical Trials Information for Patients and Caregivers. https://www.cancer.gov/about-cancer/treatment/clinical-trials

Food and Drug Administration. Clinical Trials and Institutional Review Boards. https://www.fda.gov/consumers/consumer-updates/fda-101-clinical-trials-and-institutional-review-boards

American Cancer Society. What are the phases of clinical trials? https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html

About UPMC Hillman Cancer Center

UPMC Hillman Cancer Center provides world-class cancer care, from diagnosis to treatment, to help you in your cancer battle. We are the only comprehensive cancer center in our region, as designated by the National Cancer Institute. We have more than 70 locations throughout Pennsylvania, Ohio, New York, and Maryland, with more than 200 oncologists. Our internationally renowned research team is striving to find new advances in prevention, detection, and treatment.