What is a Clinical Trial?

Clinical trials are studies designed to evaluate new treatment options for patients who have been diagnosed with cancer. A clinical trial provides information regarding the effectiveness and the safety of different types of cancer treatments. The goal of clinical research is to find new treatment options that will provide better outcomes for cancer patients.

Low Country Cancer Care provides access to many new evolving therapies. We have access to new clinical trials of treatment through the Atlanta Regional Community Clinical Oncology Program (CCOP). If the need arises, we coordinate referrals and/or therapy to major cancer centers across the United States.

What are the Phases of a clinical Trial?

Clinical trials are conducted in phases. The phases are used to obtain specific information about the treatment or experimental drug.

Phase I trials: A small number or participants are used to test an investigational cancer drug or treatment. The main focus is to determine the safety of the drug in humans. They evaluate the safe dose range and identify possible side effects from the drugs and/or treatment.

Phase II trials: After completing the Phase I trials, the information is used to treat a slightly limited number of participants. Phase II uses the information gathered from Phase I to further evaluate the safety and effectiveness of the drug and or treatment.

Phase III trials: The experimental treatment is given to a larger group of participants in a variety of clinical settings to evaluate its safety, effectiveness, and to monitor any side effects.

Phase IV trials: Once the drug has been approved by FDA, this is when the post marketing studies are conducted to continue to gain more information about the benefits and safety of the cancer drug and/or treatment.

Patient Eligibility and Informed Consent

Low country Cancer Care's research staff will give you the specific information related to the trial so you, the patient, can make an informed decision to participate, the process is designed to make certain that you fully understand the clinical trial plan before agreeing to participate. You will never be signed up for a study without giving your consent. Even after giving your consent to participate, you have the right to leave the trial at any time without giving a reason.

What are the benefits and risks to enrolling in a clinical trial?

Benefits:

• Enrolling in a clinical trial gives you access to cutting edge cancer treatments and drugs that are not widely available.
• You are carefully monitored and evaluated throughout the trial. Additional tests and visits to your doctors' office may be required during the trial.
• You will play a more active roll in your healthcare.
• You will be helping cancer research by developing new cancer drugs and/or treatment regimens.

• New cancer treatments and drugs may have side effects that are not known to your doctors.
• There is not a guarantee that the cancer drugs and/or treatments from the trial will be effective on your disease.