Cancer Clinical Research
T
he NEA Baptist Clinic’s oncology practice is a private oncology practice that offers comprehensive patient care including research opportunities for most cancer types. The oncology department has been active in clinical trials for approximately 30 years.
Today, patients benefit from this environment that combines a caring staff with clinical research. The NEA Baptist Clinic oncology physicians conduct research in a broad area. Trials ranging from Phase I to Phase IV are conducted in collaboration with the National Cancer Institute, cooperative groups, pharmaceutical companies, Sarah Cannon Research Institute, Baptist Cancer Center in Memphis, Tennessee and now through our new affiliation with Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. When diagnosed with cancer, it is important to know what treatment options are available. One of those options might be that of a clinical trial.
Cancer clinical trials open • Breast • Lung • Colon • Bladder • Prostate • Melanoma • Myelodysplastic syndrome • Acute myeloid leukemia • Chemotherapy-induced nausea and vomiting.
What is a clinical trial? Clinical trials are also known as research studies. A clinical trial is conducted with patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help patients. They are the final step in a long process that began with research in a lab. During a trial, more information is gathered about a new treatment, the side effects, and how well it will work. The treatments now considered standard for patient care, were at one time clinical trials. Cancer clinical trials answer questions about new ways to: • Treat cancer • Find and diagnose cancer • Prevent cancer • Manage symptoms of cancer or side effects from treatment Patients take part in clinical trials for a number of reasons. Some of the reasons include hope for themselves, access to medicine or treatment before it is available, or the knowledge they made a contribution to research. Regardless of the personal reasons, a clinical trial participant impacts the development of new treatments that may provide better care or a possible cure. Clinical trials follow strict guidelines. There are phases of trials that evaluate safety and efficacy. Phase I studies work to find a 14 NEA HEALTH • Spring 2014
safe dose, how the treatment should be given, and how the treatment affects the human body. Phase II studies determine if a new treatment works on a certain cancer and to see how the new treatment affects the human body. Phase III studies compare the new treatment with the current standard treatment. And finally, Phase IV studies further access the long term safety and effectiveness of a new treatment.
In addition to phases of trials, each specific research protocol is reviewed and approved by the Food and Drug Administration and an Institutional Review Board to make sure they are conducted in an ethical manner. Phase III trials have an additional group known as the Data Safety and Monitoring Committee that look at test results, monitor the safety of the research participant, and decide if the study can continue. Before a patient enrolls in a clinical trial, a detailed description of the study as well as risks and benefits must be carefully explained. Once the protocol is explained, the decision to participate is up to the patient. The physician and the research team will be available to help the patient with any questions or concerns. If a patient decides to enroll in a clinical trial, an informed consent must be signed. The informed consent is a critical part in ensuring patient safety. Benefits of clinical trials include: • Health care provided by leading physicians • New drugs and interventions before commercially available • Close monitoring of the patients health and any side effects • More active role in the patients own health care • Opportunity to make a valuable contribution to cancer research However, the primary reason oncology patients participate in clinical trials is because it may benefit them and it will certainly benefit their children and grandchildren. And, it is important to know a difference has been made in the future of cancer care.