CLINICAL TRIALS AT UM/SYLVESTER

CLINICAL TRIALS AT UM/SYLVESTER

W HAT IS THE PURPOSE OF THIS BROCHURE? We created this brochure for people who may be interested in learning about or participating in clinical trials, also called clinical or research studies. New clinical trials are under development every day at UM/Sylvester -- to find more effective treatments for cancer and other serious illnesses. Clinical trials allow patients to participate in the newest treatments with potentially life-saving therapies. To learn more about UM/Sylvester s Clinical Trials Matching Service for cancer patients, visit www.sylvester.org or call 1-866-574-5124.

WHAT IS A CLINICAL TRIAL? A clinical trial is a type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Clinical trials are conducted in all areas of medicine. UM/Sylvester conducts a wide range of clinical trials and those focused on cancer care help physicians and scientists answer specific questions about new therapies or new ways of using known therapies allowing patients access to the newest treatments under development. WHY ARE CLINICAL TRIALS IMPORTANT? Clinical trials contribute to knowledge and progress in the fight against cancer and other serious illnesses. Every trial weighs the risks versus the benefits for the participants, with the goal to minimize risk and maximize benefits. If a new treatment proves to be safe and effective in a clinical trial, it may become a new standard of treatment that can help many patients. Many of today s most effective standard treatments are based on the results of previous clinical trials. Patients who participate in clinical trials will receive either the new treatment being tested or the current standard of care for their illness. New therapies may carry unknown risks. But if a new remedy proves effective or more effective than the current standard of care, clinical trial participants are the first to benefit. WHAT HAPPENS IN A CLINICAL TRIAL? In a clinical trial, patients receive new therapies, medications, or sometimes even complementary or alternative therapies while doctors study the effects of these treatments. Although clinical trials may carry certain risks to the participants, steps are taken in every study to monitor for possible side effects and minimize risk. 1

Patients who participate in a clinical trial may receive care at UM/Sylvester, a hospital, a clinic, and/or a doctor s office. Their treatment teams may include physicians, nurses, social workers, and other health professionals, all of whom follow the patient s progress closely. Patients follow treatment plans for a specified length of time as prescribed by their physicians, and also may have other responsibilities such as keeping a log or filling out forms about their health. Patients also may be asked to participate in non-therapeutic trials where there are no anticipated clinical benefits and only carry minimal risks to patients, e.g., collection of data via blood tests. HOW IS THE RESEARCH CARRIED OUT? HOW ARE PATIENTS PROTECTED? In clinical trials, patient safety and the research outcomes are of the utmost importance. In the United States, the Food and Drug Administration (FDA) monitors clinical trials to ensure safe and effective drugs are available to the public. In order to protect patients and to ensure accurate results, clinical trials must adhere to strict scientific and ethical guidelines. These include: 1. A Plan That Explains How The Trial Will Work The clinical trial investigator (often referred to as principal investigator or PI), usually a physician, prepares an action plan (or protocol ) for the clinical trial. This plan describes the purpose of the clinical trial as well as the procedure. It also outlines the number of participants who will take part in the trial, the type and frequency of medical tests each patient will receive, and the treatment plan. Each physician involved in the clinical trial must follow the same protocol. For patient well-being, each protocol must be approved by the clinical trial s sponsor organization (such as UM/Sylvester) and UM/Sylvester s Institutional Review Board (IRB) at each clinical trial site. 2

The IRB, which includes members of the community, clergy, and health professionals, reviews the protocol to assess the potential benefits and risks of participating in the trial. 2. Eligibility Requirements For Study Participants The protocol for each clinical trial names specific characteristics or eligibility criteria that all patients must share. These may include age, gender, and the type of illness, as well as prior treatment and medical history. Eligibility criteria are important in medical research for several reasons. During the clinical trial screening process, criteria help ensure patients with appropriate conditions enroll, while patients with medical disorders that may increase risk are excluded from testing. After a clinical trial, the criteria can help dictate which patients will benefit from the new medication. For instance, a new treatment may be effective against one type of cancer or illness but not another, or it may be more effective for men than women. 3. A Controlled Process With Different Phases To Answer Different Scientific Questions 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 are the first step in testing a new treatment in humans. In these clinical trials, scientists investigate if and how the medication can be provided including proper dosage and defined side effects. A Phase I trial usually enrolls only a small number of healthy volunteers or patients with a specified illness (such as cancer) with limited treatment options. Phase I trials also look for the best way to administer a new medication 3

(by mouth, injected into the blood or muscle) as well as how frequently to administer it. Phase II trials begin to evaluate how well new medications work in a particular patient population, and further define side effects at that dose. (For instance, whether a drug shrinks a tumor or improves blood test results.) Generally, only a small number of patients participate in Phase II trials, which usually focus 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 of care. A participant usually 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 are conducted once a medication has been approved by the FDA to find new indications or newer ways of using existing medications. These studies continue to evaluate the medication to learn more about its long-term benefits and side effects. SHOULD YOU TAKE PART IN A CLINICAL TRIAL? While clinical trials have helped many people beat cancer and other illnesses, and helped establish preventive, diagnostic, and treatment therapies that have become standard clinical practice, they may not be appropriate for everyone. This is a question only you and your physician can answer. Learning you have a serious illness and deciding what actions to take can be overwhelming. Participating in a clinical trial may be a good choice for some people, but anyone who considers participating in a study should be aware of potential risks and benefits. Possible Benefits Clinical trials offer high-quality care, and may provide access to new treatments that are eventually proven effective as part of a 4

study prior to FDA approval. If you participate in a clinical trial and do not receive the new treatment being tested, you will receive the current standard of care as well as careful monitoring of your condition and any possible side effects to the standard treatment. Some studies involve incentives such as payment or a gift for participation. Possible Risks New treatments under investigation are not always better than, or even as good as, the current standard of care. There is always a potential for unexpected side effects, which may be worse than side effects from the current standard of care. Even if a new approach has benefits, it may not work for everyone. In addition, studies usually involve some degree of risk, but if study-related injury occurs, treatment will be available in most cases. Also, health insurance and managed care providers may not cover all the patient care costs of a clinical trial. To be sure, you should always inquire in advance to determine what costs your health care provider will pay, and talk to the physician, nurse, or social worker involved with your clinical trial. YOUR RIGHTS AND YOUR PROTECTIONS One of your most important rights as a patient is the right to informed consent. Informed consent means you must be given all of the facts about a clinical trial before you agree to participate. This includes details about any treatments and tests you may receive and any known possible benefits or risks involved. Your doctor or nurse will give you an informed consent form that includes all of the facts concerning your clinical trial. If you decide to take part in the clinical trial, you will be asked to sign this consent form. Signing a consent form does not mean you must complete the clinical trial. You may elect to stop participating in the clinical trial at any time. If you decide to leave a clinical trial, you can then discuss 5

other treatments and care options with your doctor. At all times, your medical records and associated information remain confidential to the extent permitted by law. If you have any questions or concerns about your participation or care in a UM/Sylvester clinical trial, please contact the University of Miami s Human Subjects Research Office (HSRO) at 305-243-3195. CLINICAL TRIALS MATCHING SERVICE On November 1, 2004, leaders in Florida s cancer community launched the Florida Cancer Clinical Trials Cooperative, Inc. (FCCTC), in an effort to provide expanded treatment options for Floridians who are fighting cancer. The FCCTC Information and Matching Service, powered by EmergingMed, is an interactive, web-based system that enables cancer patients and others to access clinical trials available throughout Florida. In May 2005 as an outgrowth of its participation in the FCCTC UM/Sylvester launched its own Clinical Trials Matching Service, which is designed to provide a fast, simple, and confidential way to access information about clinical trials in South Florida, throughout the state, and the nation. To learn more about cancer trials at UM/Sylvester, visit our website at www.sylvester.org or call 1-866-574-5124. 6

To see a UM/Sylvester cancer specialist for an initial visit, second opinion, or clinical trial screening, call 305-243-1000, 1-800-545-2292, or visit UM/Sylvester s website at www.sylvester.org and click on Clinical Trials. To contact UM/Sylvester s Clinical Trials Matching Service directly, call 1-866-574-5124. UM/Sylvester Comprehensive Cancer Center 1475 N.W. 12th Avenue Miami, Florida 33136 305-243-1000 1-800-545-2292 UM/Sylvester at Deerfield Beach 1192 East Newport Center Drive Suite 100 Deerfield Beach, Florida 33442 1-800-545-2292 www.sylvester.org 7