Cancer Institute

  • Cancer Clinical Trials

    The University of Mississippi Medical Center (UMMC) has been a longstanding participant in cancer research studies also called clinical trials. UMMC currently participates in the Children's Oncology Group, Gynecologic Oncology Group, Radiation Oncology Group, Southwest Oncology Group, and studies offered through the National Cancer Institute's Cancer Trials Support Unit (CTSU). UMMC has been a member of the Southwest Oncology Group and the Children's Oncology Group (formerly the Pediatric Oncology Group) since the early 1970s. UMMC participates in a limited number of institutional studies and industry sponsored studies. UMMC has access to a variety of cancer treatment studies.

    What is a clinical trial?

    A clinical trial is a test to determine the safety and/or effectiveness of a medical intervention. Well-designed clinical trials are the only reliable means of finding out if a medical treatment or a diagnostic tool works. Clinical trials answer questions about new cancer treatments - new medications, devices, surgical techniques, radiation, even a new combination of drugs already known to help treat cancer. Medical progress without clinical trials is impossible. One can never tell whether something is safe and effective without testing it in patients. 

    Who participates in a clinical trial?

    The physician who leads a clinical trial is called "principal investigator" or PI. Large clinical trials that take place at many different hospitals and have multiple PIs. PIs are responsible for the conduct of the trial. Physicians are assisted by research nurses and coordinators, who help manage patients and make sure that patient care follows the rules of trial. Clinical trial nurses and coordinators screen patients for trial eligibility, collect and manage clinical data, and coordinate relationships between investigators and the institutional committees that monitor trials.

    Physicians, nurses and clinical trial coordinators are responsible for explaining the trial to patients and their families, and answer any questions about the trials. Anyone involved in research with human participants must be trained and certified in protection of human subjects, including not only physical safety but emotional safety and confidentiality of patient information.

    Patients enrolled in a clinical trial are called participants, and they are the most important members of the team.

    Participants in trials are not "guinea pigs." The participant is always in charge and can decide to participate or to withdraw from a trial at any time. Many participants feel that taking part in a clinical trial helps them take charge of their care and to help other, future, patients who might benefit from the results. 

    What's in a phase?

    Different phases are designed to fulfill a specific purpose.

    • Phase 0 studies figure out how a new treatment works and helps identify the patients that may benefit from it.
    • Phase 1 studies determine if the new treatment is safe. Participants are often those who have not responded to standard treatments. If no side effects are observed, a new group of participants receives a higher dose. If serious side effects are noted, the treatment is stopped.
    • Phase 2 trials continue to monitor the safety of the drug and how well the new drug works. They may look at timing of drugs or a new combination of drugs.
    • In phase 3 trials, the treatment is tested in a large group of participants. With experimental treatments, these trials may lead to FDA (Food and Drug Administration) approval, after which the new treatment can become widely available to cancer patients.
    • Phase 4 studies look for any rare side effects that can only be seen when the treatment is used in thousands of patients over a longer period of time.

    Risks of participation: Who watches out for the patient?

    Anything in life involves some risk, and there are risks associated with participation in clinical trials. However, in any study involving human participants, safety always comes first. Several organizations monitor clinical trials very carefully.

    Each clinical trial must be approved by an institutional review board (IRB). They review each clinical trial to make absolutely sure the trial is designed to protect patient safety and rights. No trial can begin without IRB approval. The IRB includes not only physicians and health care professionals but also lay members of the community. IRBs also make sure that the doctors don't have a financial interest in any drug or treatment being investigated.

    Trials with experimental treatments or devices that are not approved for use in the U.S. must also be reviewed by the FDA. If the doctors and scientists at FDA don't believe the trial can be done safely, they will not allow it to take place. The FDA has the power to close a study and to shut down all trials at hospitals and centers that do not follow rules for safety.

    The IRBs must follow strict requirements when they review a study. They will not allow patients to participate in a new trial if it hasn't been first approved by them.

    The National Cancer Institute (NCI) also has its own review panels that must review all clinical trials funded by the National Institutes of Health National Cancer Institute, even if it's already been approved by the FDA.

    Phase 2, 3 and 4 trials must also be monitored by a Data and Safety Monitoring Committee or board, which can stop a trial immediately if results show that the new treatment works and should be be made available to all patients. If the results show it does not work or there are excessive side effects, they will stop the trial. 

    Benefits of participation

    If no one volunteers to take the carefully controlled risks associated with clinical trials, all medical progress will stop. Our children will have no better chance of surviving cancer than we do.

    Participation is always voluntary. Before joining a trial, each participant must review and sign an informed consent document that describes the purpose of the trial, its risk and benefits in plain and simple language.

    Participants are encouraged to ask questions. Your doctor or nurse should answer any question you may have about the trial.

    For more UMMC information regarding cancer clinical trials:

    • Adult cancer research and registry - (601) 984-1095
    • Children's hematology/oncology - (601) 984-5220

    If you would like to learn more about clinical trials, the National Cancer Institute has a number of documents and publications on its website.