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.
Our research department provides access to many new evolving therapies. We are actively sought out by many of the major pharmaceutical companies to provide state of the art clinical trials of new treatments for cancer. We also have access to new studies 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 of participants are used to test an investigational 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 drug/treatment.
Phase II trials: After completing the Phase I trials, the information is used to treat a slightly larger limited number of participants. Phase II uses the information gathered from Phase I to further evaluate the safety and effectiveness of the drug/treatment.
Phase III trials: The experimental treatment is given to a large group of participants in a variety of clinical settings to evaluate its safety, effectiveness and to monitor the side effects.
Phase IV trials: Once the drug has been approved by the FDA, this is when post marketing studies are conducted to continue to gain more information about the benefits and safety of the drug.
Who can participate?
Speak with one of PCI’s research nurses to obtain guidelines regarding the inclusion/exclusion criteria for a study. Each study has eligibility criteria that you must meet in order to participate. Our research nurses will inform you if you meet the criteria to participate in the study.
What is the informed consent process?
PCI’s research staff will give you all the specific information related to the trial so you can make an informed decision to participate. The process is designed to make certain 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 Research trial?
- Enrolling in a clinical trial gives you access to treatments and drugs that are not widely available.
- You are carefully monitored and evaluated throughout the trial. Additional tests and visits to the doctors’ office may be required during the trial.
- You will play a more active role in your healthcare.
- You will be helping cancer research by developing new treatment regimens.
- New treatments and drugs may have side effects that are not known to the doctors.
- There is not a guarantee that the drugs from the trial will be effective in your treatment.
How do I find a clinical research trial at PCI?
For details regarding clinical research trials, click here or go online to www.piedmontcancerinstitute.com and select the Clinical Trials tab. From the drop-down list that appears, choose "Current Clinical Trials." You can also contact one of our Research nurses at 678-298-3235.