Clinical Trials

Patients who participate in clinical research studies receive state-of-the-art cancer treatments from national experts. Even though benefits cannot be guaranteed, those that participate in these studies often have access to the therapies and may be the first to gain benefit from them. Many patients treated for cancer are now living longer because of clinical trials.

Clinical Research at Mercy Cancer Centers
The Baptist Regional Cancer Center clinical research staff is responsible for the research coordination and data management for the oncology protocols. More than 70 protocols are underway in the treatment of most cancers. In conjunction with national study groups such as the Gynecologic Oncology Group (GOG), Eastern Cooperative Oncology Group (ECOG), and numerous major pharmaceutical company-sponsored clinical trials, we are able to provide area residents access to the latest cancer treatments without the need to travel to other parts of the country.

Baptist’s Research Program is a partner with Tennessee Cancer Specialists in order to provide greater access to clinical research studies for people within the region. In geographically remote areas of eastern Tennessee and Kentucky, we have established out-reach clinics to improve access to care. We now have clinics in Newport, Sevierville, Morristown, Etowah, Harrogate, Knoxville Breast Center, Rockwood, Williamsburg Kentucky, and Baptist Hospital West.

How does a drug or treatment regimen go through the Clinical Trials process?
The development of new anticancer agents and treatment strategies occur in different phases. Each phase is designed to determine specific information about the drug or treatment, such as, risks, safety, tolerated dose, and effectiveness when given alone or when 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 involve a small number of patients that has either failed standard therapy or no other known treatment is effective for this type of cancer. At times, this will be the first use of the drug or therapy in humans. The primary goals are to determine the maximum tolerated dose, the side effect profile, and whether this treatment has any effectiveness in the treatment of cancer. The information gathered in these trials will be used to take the treatment to phase II studies.

Phase II Trials:
Patients participating in Phase II studies are usually of a specific cancer type. The dose and schedules have been determined in the phase I trials. The number of patients enrolled is higher than Phase I and may increase depending on the number of responses seen. Drugs or therapies that are shown to be active in phase II trials may become standard of care or be further evaluated for effectiveness in phase III trials.

Phase III Trials:
These trials compare a new drug or therapy with a standard therapy in a randomized and controlled manner in order to prove effectiveness. Randomization is a procedure like rolling dice or flipping a coin. Participants are randomly chosen to participate in the different treatment groups. Phase III trials require large number of patients to measure the statistical validity of the results. The results can be affected by the patient’s age, sex, race, and other unknown factors. In order to enroll an adequate number of patients, several physicians (investigator) from different institutions participate in phase III clinical trials.

Eligibility
Clinical trials enroll people who are alike in certain ways, depending upon the study’s purpose. Potential participants must meet strict eligibility criteria to be a part of a study. Each trial lists certain specific requirements such as type of disease, health of the patient, and prior therapies. Patients who qualify for a clinical trial decide, with the advice of their physician, whether to participate in the study. The patient will be made aware of both the risks and benefits of the clinical trial before making a decision. You will never be placed on a clinical trial without your knowledge and permission. All qualified patients involved in clinical trials sign a consent form before the study begins.

If you qualify, we hope that you and your family will consider participating in this worthwhile endeavor. Please do not hesitate to talk to your physician about clinical trials that may be available for your participation.

For more information about Clinical Trials at Mercy Cancer Centers, please call (865) 632-5717 or (865) 632-5595.