Clinical Trials & Research
As the region’s only academic medical center, The University of Tennessee Medical Center participates in research studies of national merit through its Office of Clinical Trials. They fulfill the medical center's mission of service through discovery by offering a wide range of oncology clinical trials to advance cancer research. Each scientifically-based oncology study explores optimal ways to prevent, diagnose, and/or treat cancer.
All research from Bayer® aspirin to the latest in chemotherapy treatment, innovative procedures and state-of-the-art diagnostic technology began with clinical trials. The goal of each oncology clinical trial is to discover better ways to prevent cancer, diagnose cancer and/or treat cancer. The cancer clinical trials process is based on long-term, scientifically designed cancer research studies which takes years in discovery and development and hundreds of millions of dollars.
At the present time, we offer more clinical trials to treat more types of cancer than anyone in the region. Our patients have access to the most comprehensive and up-to-date clinical trials utilizing medications and therapies to improve quality-of-life and prolong longevity.
The University of Tennessee Medical Center embodies its mission of healing, education, and discovery. As healthcare evolves and the needs of our community change, the Cancer Institute continues to focus on expanding the frontiers of Medicine through our innovative cancer therapies.
The Cancer Institute Process
Every clinical trial offered at UT Medical Center goes through a careful process of reviews and approvals by board certified oncologists before it is opened for participation.
Institutional Review Board (IRB)
Each study protocol is submitted to the IRB. This unbiased panel of scientific and non-scientific members must not have a direct role in the studies being considered. The IRB functions to protect all human subjects participating in research projects by assuring the studies are conducted in accordance with all state and federal regulations. The IRB monitors each protocol and related materials from the beginning of the study to the end and through a several year process of surveillance.
A variety of studies are sponsored by the National Cancer Institute (NCI) and other government agencies. For example, the UT Medical Center is a “member institution” of the Southwest Oncology Group (SWOG). SWOG is one of the largest national clinical trials cooperative groups and is funded by the NCI. By being a member of SWOG, the Cancer Institute has access to many federally funded study trials. UT Medical Center is the only SWOG member institution in the Knoxville area.
In addition, the Cancer Institute conducts various pharmaceutical and biotechnological company-sponsored research studies, collaborates with other cancer centers around the country and develops its own internal, investigator-initiated clinical trials. For example, internal PET/CT clinical trials studies are offered in collaboration with the Molecular Imaging and Translational Research (MITR) Program, making the most advanced diagnostic equipment in the world available to patients.
The UT Medical Center research team offers more than 50 ongoing clinical trials that are accepting new participants. A monthly update of the complete listing is provided at the top of this page. Regardless of the type of clinical trial patients take part in, they can be assured they will receive the most comprehensive, multidisciplinary care available.
Choosing a Clinical Trial
Some of the benefits of participating in a clinical trial are:
- Participants have access to promising new approaches that are often not available outside the clinical trial setting.
- Partipants may receive more intense monitoring from the research team
- Participants may be the first to benefit from the new method under study.
- Results from the study may help others in the future.
Phases of Clinical Trials
Development of new cancer fighting drugs and treatment strategies occurs in four phases. Each phase is designed to determine specific information about the potential new treatment such as its risks, safety and effectiveness compared to standard therapy. The hope is that the new therapy will be an improvement over the previous standard therapy.
Phase I Trials:
This phase is probably the most important step in the development of a new drug or therapy. These trials usually involve a small number of patients for whom other standard therapies have failed or no known alternative therapy is available. Phase I therapy may produce anti-cancer effects and a small number of patients may benefit. However, the primary goals of this phase are to determine anticancer activity in humans, the maximum tolerated dose of the treatment, the manner in which the drug works in the body, the toxic side effects related to different doses and whether toxic side effects are reversible. Upon completion of phase I trials, the information that has been gathered is used to begin phase II trials.
Phase II Trials:
Once the information is gathered and analyzed from phase I trials, phase II trials are designed to determine the effectiveness of the treatment in a specific patient population at the dose and schedules determined in phase I. These trials usually require a slightly higher number of patients than phase I trials. This number may increase depending on the number of responses as the phase II trial progresses. Drugs or therapies that are shown to be active in phase II trials may become standard treatment or be further evaluated for effectiveness in phase III trials.
Phase III Trials:
Phase III trials compare a new drug or therapy with a standard therapy in a randomized and controlled manner in order to determine proof of effectiveness. Phase III trials require a large number of patients to measure the statistical validity of the results because patient age, sex, race, and other unknown factors could affect the results. To obtain an adequate number of patients, several physicians (investigators) from different institutions typically participate in phase III clinical trials.
Phase IV Trials:
Once the drug or treatment becomes part of standard therapy, the manufacturer of the drug may elect to initiate phase IV trials. This phase includes continued evaluation of the treatment effectiveness and monitoring of side effects as well as implementing studies to evaluate usefulness in different types of cancers.
For more information contact the Office of Clinical Trials 865.305.9773