Clinical Trials at Thompson Cancer Survival Center

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What Are Clinical Trials and Why Are They Important? A clinical trial is a research study conducted with patients to discover better methods of prevention and treatment of certain diseases, such as cancer. Clinical trials answer important scientific questions about promising new drugs or devices which lead to future advances in cancer care. When new therapies are proven superior to current ones, the new therapies become the standard of care. Many of today’s most effective standard treatments result from previous clinical trials. Participants in clinical research studies receive state-of-the-art or cutting-edge treatments from international cancer experts. Even though benefits cannot be guaranteed, the patients who participate in clinical research studies are among the first to gain from the more effective and newer therapies. Many patients treated for cancer are now living longer because of clinical trials. Thus, the purpose of clinical trials is accomplished – patients achieve better health outcomes. The Thompson Cancer Survival Center clinical research staff is responsible for research coordination and data management for oncology protocols in cooperation with several research groups: the Southwest Oncology Group, (SWOG), the National Surgical Adjuvant Breast and Bowel Project, (NSABP), and the Sarah Cannon Research Network. In addition, research is conducted with major, nationally recognized pharmaceutical sponsors. To date there have been over 1,000 patients enrolled on clinical trials treatment since the department began in 1988. There are currently 45 active research protocols, addressing most major cancer sites, the breast cancer prevention study (STAR), and the prostate cancer prevention study, SELECT. Thompson’s Research Program recently partnered with oncologists at Methodist Medical Center of Oak Ridge in order to provide greater access to cancer research studies for people within the region. Clinical Research Coordinators presently work with physicians at Thompson Cancer Survival Center, Blount Memorial Hospital, Methodist Medical Center and Parkwest Regional Medical Center to ensure that area patients are given the opportunity to participate in a clinical trial if the patient so chooses. These oncology certified nurses are a highly qualified team of patient-oriented professionals who are very dedicated to their jobs and to educating the community about clinical research. The unique feature of the clinical trials department is its excellent service delivery and the staff’s ability to combine quality research and superior patient care. How Does A Drug or Treatment Regimen Go Through the Clinical Trials Process? Clinical Trials are performed in phases. The first step is for researchers to determine if the drug is safe. A Phase I study is the first step in testing a new drug or treatment regimen in humans. Researchers look for the best way to give the drug to the cancer patient (via IV, by mouth, etc.) and how the treatment can be given safely (the most therapeutic dose). During this testing, the patients are monitored closely for side effects. Because less is known about the possible risks and benefits of the treatments used in Phase I trials, the number of patients involved is usually small and include those who would not be helped by other known treatments. Phase II studies are done to test the efficacy of the medication or treatment once it has been proven to be safe. Researchers focus on whether or not the medication or treatment has an anti-cancer effect (ability to shrink the tumor or alleviate some side effects of the tumor) and continue assessing participant safety. Like Phase I, these studies also usually include a small number of people. Phase III studies are the most common types of research done in cancer patients. These trials compare the effectiveness of the experimental therapy to patients taking standard treatment. Phase III studies usually do not occur unless a medication or treatment has been successful in both Phase I and Phase II trials. In a Phase III trial, participants are usually randomized to either the experimental therapy or standard therapy. Randomization is a process kind of like rolling dice. Participants are randomly chosen by a computer to be in one of the treatment groups. Neither the participant nor the investigator have any influence as to which treatment group is selected. By comparing the experimental therapy to the standard of care, researchers can see if the new treatment is better than what is already being offered. Phase III studies usually involve large numbers of people, sometimes hundreds or thousands are sought from around the country or around the world. Are There Clinical Trials for the Prevention of Cancer? Yes. Clinical research is done not only to find the best treatments for cancer, but it is also used to see if certain activities, like diet and exercise, or certain medications can help to prevent cancer from occurring in healthy people who have never had the disease. Many times in prevention trials, the research medication is compared to a placebo, or a tablet that looks like the study drug but does not contain any active medication. The participants would have an equal chance of getting either the active drug or the placebo during randomization. A placebo group is needed in prevention trials in order to measure the effectiveness of the study medication. This procedure is common and acceptable practice. A placebo is never given to a participant in a cancer treatment clinical trial in which an effective treatment is available. Who Can Participate In A Clinical Trial? Clinical trials enroll people who are alike in certain ways, depending on the study's purpose. Potential participants must meet strict eligibility criteria in order to be a part of a study. Each trial lists specific requirements such as age, extent of disease, and prior therapies. The physician conducting the trial will review each potential participant's medical history and the trial requirements to determine if that person is an appropriate candidate. If the investigator feels that the potential participant is eligible for a study, the procedures, possible benefits and risks, side effects, and alternative therapies will be discussed. The participant will also read an informed consent document that will explain the details of the study requirements. What is Informed Consent? Informed consent is a process where the potential participant learns about the clinical trial and decides whether or not to participate. A written copy of the informed consent will be given to the participant to review before joining the study. The investigator or research coordinator reviews the consent with the patient and addresses any questions or concerns prior to the signing of the consent form. This process allows the opportunity for the patient to learn as much as possible about the trial before making an informed decision to participate. Potential participants should not be afraid to ask questions during this time. Individuals are never obligated to continue with a study even after the informed consent is signed and may leave the trial at any time. They are then given the opportunity to discuss alternative treatments with the physician. What Protection is Provided for the Participant in a Clinical Trial? The FDA requires that every clinical trial be reviewed and approved by a group of people called an Institutional Review Board (IRB). The IRB consists of members of the community with both medical and non-medical backgrounds. It is their role to continually review the general progress of any trial. The primary responsibility of the IRB is to assure that a clinical trial is well designed and does not involve undue risks to the participants. How Do I Know If A Clinical Trial Is Right For Me? You should talk with your doctor about all your treatment or prevention options, including clinical trials. Ask if there is a clinical trial available that you might be eligible for and if he or she thinks you would benefit from participating in a trial. Your decision to participate should be made after careful consideration and understanding of all available treatment options and their potential benefits, risk and side effects, the cost, if any, of participation in the trial, and the location and duration of the trial. If you have any questions please call Clinical Trials at (865) 541-1812 or fax (865) 541-1162.

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