Clinical trials are research studies that help scientists and doctors find ways to improve health and cancer care.
As a National Cancer Institute (NCI)-designated cancer center — and the only NCI-designated cancer center in South Florida — Sylvester Comprehensive Cancer Center, part of the University of Miami Health System, provides patients with increased access to clinical trials. That may mean increased access to new and innovative cancer treatments.
Our doctors and researchers are currently involved in more than 550 clinical trials. Our goal is to advance the future of cancer treatment while improving the lives of every patient.
Clinical trials are research studies that find safe and effective new ways to prevent, detect, or treat cancer. Because it typically takes years for these novel treatments and therapies to receive Food and Drug Administration (FDA) approval, clinical trials often give participants promising options that might not have been available to them otherwise. The findings from these trials also help inform future cancer diagnostics and treatments.
There are four clinical trial phases. They include:
Phase 1: A test involving a small group of people to learn about the safety and side effects of a new treatment or therapy
Phase II: A test involving a larger group of people to further study the safety and effectiveness of a new treatment or therapy
Phase III: A test involving a large group of people to confirm the effectiveness of the new treatment or therapy, monitor side effects, compare it with standard or similar treatments, and collect information on how to use it safely
Phase IV: A test that tracks the safety of a new treatment or therapy in the general population after it gains FDA approval
Yes. In most cases, you can still receive standard-of-care treatment for cancer while participating in a clinical trial. Talk to your doctor and trial investigators, though, to be sure.
In general, clinical trials are safe. They may have potential risks because these studies often involve unproven treatments and drugs. It’s best to weigh the clinical trial risks and benefits with your doctor before you decide to enroll.
If you have clinical trial safety concerns, remember trial investigators will closely monitor you, and each trial must meet certain safety protocols. In addition, clinical trials must be approved and monitored by an Institutional Review Board (IRB) to verify that the risks are acceptable and justified by any potential benefits.
If a treatment in a cancer clinical trial doesn’t work, the investigators will usually stop the study. They’ll then examine the data to try to understand why the treatment failed and publish the results, including the negative findings. Regulatory agencies will not approve an ineffective treatment for clinical use.
Typically, you don’t have to pay to participate in a clinical trial, although there may be some out-of-pocket costs. The drug manufacturer or company sponsoring the study usually pays the cost of clinical trials.
Still, you should ask the trial investigator about any costs before you enroll.
Before enrolling in a clinical trial, talk with your oncologist, the trial research team, and consult your health plan to determine what costs you may face. If you learn you’ll be responsible for certain expenses, you can talk to your health plan provider about your specific coverage. You may need to send them information, such as a letter from your doctor, that explains why the clinical trial may benefit you.
In a clinical trial, we protect participants’ privacy in several ways. First, we replace personal details like your name with a unique code, meaning no one can directly identify you based on data. Also, researchers remove any identifiable information when publishing their findings. In addition, we store clinical trial data in secure locations with complex safeguards in place to prevent anyone unauthorized from gaining access.