Since 1996, the Cancer Center at Northeast Georgia Medical Center (NGMC) has been participating in cancer clinical trials and is currently a partner with a variety of nationally known research networks all across the country including the H. Lee Moffitt Cancer Center, Duke University, the Sarah Cannon Research Consortium, the University of Mississippi and the National Cancer Institute. By partnering with many different national oncology groups, NGMC and its physicians are able to offer cutting-edge clinical trials to our patients, including trials for chemotherapy, radiation therapy and surgery for virtually all tumor sites including breast, lung and prostate cancers, three of the sites most often diagnosed in northeast Georgia.

By offering clinical trials to patients, physicians and clinical staff in the Cancer Center provide the very latest treatment options available. Most of the trials combine treatments that have proven effective with an additional drug or a different drug dose. Many times, patients in trials may have the chance to receive a drug that has shown promise in smaller studies but is not yet commercially available.

If you have questions about these trials, talk to your physician or call NGMC’s Cancer Center at (770)219-8800.

What is a clinical trial?
How do clinical trials work?
What are the different phases of clinical trials and what do they include?
What is a randomized trial?
What is a blinded trial?
What is a placebo?
Will my insurance cover the cost of a clinical trial?
What are the benefits and risks of participating in a clinical trial?
How can I find a clinical trial?

What is a clinical trial?

According to the American Cancer Society, many, if not most, of the advances in life expectancy and quality of life for cancer patients and survivors are a result of cancer clinical trials.

A clinical trial is a strictly monitored and carefully evaluated research study designed to evaluate potential new treatment options and find better ways to prevent, diagnose and treat cancer. A clinical trial must be conducted in order for the U.S. Food and Drug Administration (FDA) to approve a new drug or treatment. If approved by the FDA, the new drug or treatment can be made widely available to patients and may become the new standard treatment.

Some people think clinical trials are only a last resort, but in fact, clinical trials are often a good way to begin cancer treatment. NGMC enrolls more than 100 patients in clinical trials each year.

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How do clinical trials work?

The care patients receive in a clinical trial is much like the care they would otherwise receive. In fact, many times patients in a clinical trial are given extra attention because, for research purposes, all trials must be strictly monitored and carefully evaluated.

Clinical trials follow a detailed treatment plan, or “protocol.” The treatment team will make sure that the protocol is carefully followed and will closely monitor each patient’s health care during and after the trial.

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What are the different phases of clinical trials and what do they include?

Clinical trials are divided into four stages or phases:

Phase I trials help researchers determine the safest dose of a new treatment drug and the best way to administer it. They also help determine whether the new treatment has any potentially harmful side effects.

Phase II trials evaluate whether the new treatment is effective in working against a particular type of cancer (for example breast cancer).

Phase III trials compare the new treatment to the best existing treatment for a particular type of cancer. Many Phase III trials involve adding a new drug to an already-proven combination of drugs to see if the combination is more effective.

Phase IV trials use treatments that have already been approved by the FDA. Even after testing a new medicine with thousands of patients, doctors and researches may still have questions that will take many years to answer fully.

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What is a randomized trial?

Randomization is a process used in clinical trial to prevent bias. It helps ensure that unknown factors do not affect trial results. Randomization is used in all phase III and some Phase II trials.

Participants will be assigned by chance to either an investigational group or a control group. Participants assigned to the control group, will get the standard treatment for their cancer. If assigned to the investigational group, the participant will get the new standard being tested.

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What is a blinded trial?

Another method used to prevent bias in a clinical trial is to ‘blind’ a study. In a single blind study, the participant is not told if they are taking the standard treatment or the new treatment being tested. Only the doctor knows. In a double-blind study, neither the participant nor the doctor knows which treatment the participant is receiving. These studies are done, so that expectations about the experimental drug can not influence the results of the study.

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What is a placebo?

Placebos are almost never used in a clinical trial. A placebo is designed to look like the medicine being tested, but contains no drug. A study using a placebo may compare standard treatment, plus a new treatment, to standard treatment plus a placebo. If the trial does include a placebo, the participant will be told.

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Will my insurance cover the cost of a clinical trial?

Health plans and managed care providers do not always cover all patient care costs in a cancer clinical trial. Ask a doctor, nurse or social worker to help you determine in advance what costs are covered.

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What are the benefits and risks of participating in a clinical trial?

Participants of a clinical trial have the chance to help others and improve cancer care. If the new treatment approach works, the participant may among the first to benefit. By looking at the pros and cons of a clinical trial and treatment choices, participants take an active role in a decision that affects their life.

There are strict guidelines in place to protect the well-being and safety of all patients who participate in a clinical trial.

The NGHS Institutional Review Board (IRB) reviews and approves all clinical trial before the clinical trial starts accepting participants. The IRB is a group of doctors, scientists, celery, pharmacist, and consumers designed to protect participants who take part in a clinical trial. Its members make sure the risks involved in the clinical trial are reasonable when compared to the possible benefits.

As with all cancer treatment, there can be risks aswell as benefits to participating in a cancer clinical trial. Side effects and benefits vary depending upon the individual. Study drugs may be found to be more or less effective than current standard treatments and may have side effects not yet known. Yet, research shows that patients in clinical trials do as well or better than other patients and report higher levels of satisfaction with care.

A cancer clinical trial is a good choice for some people. After considering the possible benefits and drawback, you will need to discuss clinical trials along with all treatment options with your doctor and the people close to you.

If a patient or the patient’s doctor decides that the clinical trial is not in the patient’s best interest, the patient may stop treatment at anytime.

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How can I find a clinical trial?

NGMC proudly participates in about 60 clinical trials a year. Because of this, about 6 to 8 percent of cancer patients receiving treatment at the Cancer Center are enrolled in clinical trials, which is above the national average. Call 770-219-8800 for more infomation.

You can also visit the Georgia Center for Oncology Research & Education’s (Georgia CORE) website to find other trials open in Georgia at www.GeorgiaCancerTrials.org.

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