Clinical Trials FAQ

What Are Clinical Trials and Why Are They So Important?

Clinical trials provide crucial information about the safety, effectiveness, and proper use of new drugs, diagnostic tests, and treatments. They are usually done in the laboratory or clinic setting of a major institution such as a university or hospital, or at a pharmaceutical company, or at a private medical practice.

What Are the Phases of Clinical Trials?

Clinical trials are divided into four categories: phases I through IV:

Phase I: Drugs are given for the first time to a small group of people. Please be aware that Phase I trials are not designed to show effectiveness; they are designed to show that the drug is not toxic in humans. Little is known about the drugs in Phase I trials, because this is when they are usually tested in humans for the first time or are evaluations of a new dosage or new mode of administration.
Phase II: Drugs are given to a larger group of participants to further evaluate their safety.
Phase III: Drugs are given to large groups of people to confirm their effectiveness, monitor side effects, and compare them to established FDA-approved treatments.
Phase IV: These studies are usually done after the drug has reached the mainstream patient population and is FDA-approved. Information continues to be collected to determine long-term use effects.

What are the types of clinical trials?

Treatment: These trials test new drug treatments to prevent recurrence or progression of disease. They may also test new approaches to surgery or radiation therapy.
Prevention or risk-reduction: These trials seek better ways to prevent disease in people who are at high risk of developing a certain cancer.
Diagnostic: These trials attempt to find better tests to diagnose disease.
Quality-of-life: These trials explore ways to improve quality of life for individuals with a chronic illness.

How Are Clinical Trials Monitored?

Governing bodies made up of physicians; representatives of institutions and the lay public; and state and federal employees closely monitor every stage of a trial. This is done to ensure the safety of the participants as well as to ensure the integrity of the information being collected from the study. All drugs must be approved by the Federal Drug Administration (FDA) before they are given to the American public.

What Are the Benefits of Enrolling in a Clinical Trial?

Often participants have access to drugs or treatments not yet available to the general population. These drugs can also be expensive and in limited supply. Participation in a clinical trial may also entitle the enrollee to additional medical attention from physicians and nurses. Enrollees also know they are helping mankind develop new therapies for future generations of patients.

What Are the Possible Risks or Downsides of Enrolling in a Clinical Trial?

Frequently, enrollees must submit to additional tests and visits to the doctors' office to monitor their progress. There is a commitment of time and travel associated with most trials. Because there are no guarantees with trials, the participant may not derive any benefit from the treatment and may even experience adverse side effects, minor or potentially life threatening. Some participants may be randomly placed in a group that does not receive any treatment of the trial drug or may receive a placebo (a nondrug substitute).

Please be aware that Phase I trials are not designed to show effectiveness; they are designed to show that the drug is not toxic in humans. Little is known about the drugs in Phase I trials, because this is when they are usually tested in humans for the first time or are evaluations of a new dosage or new mode of administration.

Does It Cost Anything To Participate In A Clinical Trial?

Generally there is no additional charge for the enrollee. Although there are costs involved, they are usually paid for by the sponsor of the trial, or by the enrollee's health insurance company.

Do Physicians Get Paid for Conducting Clinical Trials?

In some cases, the institution sponsoring the trial compensates the physician or group enrolling the patients. Those conducting clinical trials incur expenses—such as research staff, facility, drugs, and medical supplies—and the compensation offsets those expenses.

How Long Do the Clinical Trials Last?

Depending upon the criteria collected and the phase involved, trials can last from a few weeks to five years or more.

What Happens if the Enrollee Does Not Get Better (or Even Gets Sicker) During the Clinical Trial?

Because the medical team is closely monitoring the enrollee's health condition, immediate measures can be taken should a decline in health occur. The patient's health will not be compromised because he or she is enrolled in a trial.

Where Are the GCS Clinical Trials Being Studied?

Currently there are five research sites with five lead investigators that monitor all patients on clinical trials. Dr. Mansoor Saleh monitors trials from our Northside location, Dr. Melvin Moore monitors trials from our Stemmer location, Dr. Cheryl Jones monitors trials from our Macon-Coliseum location, Dr. Rodolfo Bordoni monitors trials from our Kennestone location, and Dr. Shyam Khanwani monitors trials from our Fayetteville location. The research team is comprised of physicians and specialized clinical staff trained in research design, data collection, and analysis.

The Phase I trials are conducted at our Northside office location.

Do You Have To Be A GCS Patient To Enroll in a Trial Through GCS?

No. Your primary care physician may recommend you enroll in a trial and refer you to GCS. After you are referred by your physician, you will then be under the medical care of a GCS physician.

Who Can Participate in a Clinical Trial?

All clinical trials must have guidelines about who can participate in the study. The guidelines, or criteria, are based upon such factors as age, type of disease, medical history, and current medical condition. Before joining, a person must qualify by meeting the specific criteria set up for that trial.

Can a Participant Drop Out of a Clinical Trial?

Yes, a participant may leave a trial at any time.

How Can I Find Out More About the Specific Trials Conducted at GCS?

Talk with your primary care physician about whether enrolling in a clinical trial is right for you. You may also call (770) 496-9400 for more information.