FAQ

Clinical trials are research studies in which patients help physicians and scientists find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. Sylvester conducts a wide range of clinical trials and currently has 168 underway.

Why Are There Clinical Trials?

A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective. Participation in a clinical trial is strictly voluntary.

What Are the Different Types of Clinical Trials?

Prevention Trials – Test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer, or to prevent cancer from coming back or a new cancer occurring in people who have already had cancer.
Screening Trials – Test the best way to find or locate cancer, especially in its early stages.
Diagnosis – Test new methods for diagnosing cancer.
Treatment Trials – Test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).
Coping with Cancer Trials (also called quality of life or supportive care trials) – Explore ways to improve comfort and quality of life for cancer patients.

What Are the Phases of Clinical Trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows physicians and scientists to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of four phases:

Phase I Trials – Evaluate how a new drug can be provided safely including proper dosing and potential side effects. In addition, this phase assesses the best way to administer treatment (by mouth, injected into the blood, or injected into the muscle). A phase I trial usually enrolls only a small number of patients or healthy volunteers, sometimes as few as a dozen. Phase I trials are the first studies in humans, and, as a result, an important step to transition novel treatments from the bench to the bedside. The Phase I Clinical Trials Program at Sylvester helps doctors and scientists establish collaborative relationships that often translate into more treatment choices for patients.
Phase II Trials – Continues to test the safety of the drug, and begins to evaluate how well the new drug works. Usually, only a small number of patients participate in phase II trials, focused on a particular type of cancer.
Phase III Trials – Test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of patients and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.
Phase IV Trials – Include the continuing evaluation that takes place after FDA (Food and Drug Administration) approval, when the drug is already on the market and available for general use (post-marketing surveillance).

What Are the Benefits of Participating in a Clinical Trial?

Here are some benefits you could receive as a clinical trial subject:

Access to promising drugs, medical devices, or treatment approaches before the general public
Free or subsidized health care for the duration of the trial
A more active role in your own health care
Expert medical care at a leading health care facility
Close monitoring of your health care and side effects

And if you decide to participate in a clinical trial at Sylvester, you will play in important role in advancing scientific knowledge and helping future cancer patients.

How Can I Find Clinical Trials for My Type of Cancer?

Visit the UHealth Clinical Trials website to search for clinical trials by diagnosis, physician, trial number, or keyword.

For more information on available cancer studies, speak to your patient care coordinator or call the Sylvester Information Center at 305-243-1000 or 800-545-2292.

Sylvester is a member of Florida Cancer Trials, which strives to increase the number of Floridians participating in cancer clinical trials.