As an academic medical center, the Georgia Cancer Center in Augusta, GA is actively involved in cancer research for cancer patients.
Clinical trials are the last step in a carefully regulated, detailed scientific process that starts in a laboratory in cells or tissue and are then tested in humans - oftentimes years later and always after strenuous review.
Medical studies are supervised by a local physician and look at every stage of disease, from first diagnosis to advanced disease. All are designed to find, diagnose, treat or prevent cancer.
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases.
These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often and what dose is safe. Cancer patients who enroll in these trials have already tried other treatment options.
A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer and typically enrolls fewer than a hundred patients.
In a Phase III trial, a participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.
The maker of an approved drug may study it further in a phase IV trial to evaluate the side effects, risks and benefits of a drug over a longer period of time and in a larger number of people.
Before a patient is enrolled in a clinical trial, the individual is carefully screened against a set of criteria designed to identify a group of people that are as similar as possible.
Qualification for a trial depends on a variety of factors including stage of disease, existing health conditions and other factors. The patient then goes through what is known as “informed consent” where the goals of the trial, why it is needed and how it will work are explained in easily understandable terms. Patients should take the time to discuss all the details of a clinical trial with their doctor and family before agreeing to participate. Questions to consider include information about costs, time commitments, and potential benefits as well as side effects. This may vary, based on where the new therapy or tool is in the development and testing process.