Spagnoli Family Cancer Center Frequently Asked Questions

If you are a cancer patient or someone you know is a cancer patient, you may be interested in learning more about clinical trials. The information below offers a brief overview of the clinical trial process, with a look at key questions and terms.

What are Clinical Trials?
Clinical trials, or research studies, utilize patient volunteers to help investigate different ways to treat diseases – such as cancer. Clinical trials involve the use of investigational drugs (also known as study drugs) and drug delivery methods. Each study tries to answer specific scientific questions about different ways to prevent, diagnose, and treat whatever disease it is addressing.

Why are Clinical Trials Important?
Clinical trials contribute to the overall knowledge and progress made in developing therapies for diseases, such as cancer. These research studies are conducted to determine if a study drug or delivery method is safe and effective. Patients who agree to participate may possibly benefit from the research study, while receiving the best current standard treatment as well.

How are Clinical Trials Structured?
Clinical trials are structured into four phases:

• In Phase I clinical trials, researchers test a study drug in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase II clinical trials, the study drug is tested in a larger group of people (100 to 300) to measure its effectiveness and further evaluate its safety.
• In Phase III clinical trials, the study drug is tested in large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments, and collect information that will allow the study drug to be used safely.
• In Phase IV clinical trials, the drug is tested after it has been marketed to collect information about its effect in various populations and about any side effects associated with long-term use.

What Happens During a Clinical Trial?
In many trials, if the patient is eligible and agrees to participate through Informed Consent, the patient is randomized (by chance, like a coin toss) to either receive the current standard treatment, or the current standard treatment and the study drug regimen. If no standard treatment is available, a trial may compare the study drug to a placebo, which is similar to the study drug, but contains no active ingredient. During a trial, patients are treated and monitored by a team of health care professionals. This team will give the patient specific instructions about the trial, about more tests, and additional doctor’s visits that might be required.

Throughout the clinical trial, you come first. If there is no improvement or you experience intolerable side effects, you and your physician can decide to discontinue trial participation and resume other treatment options. Should you do so, your decision will be respected without any effect on future treatment plans.

Why Do Some Cancer Patients Choose to Participate in Clinical Trials?
Some cancer patients may participate because they are hoping for a possible cure and longer life or a way to feel better. Others find that the current standard therapies are not optimal for their cancer and wish to be among the first to participate in a research study and receive an investigational drug. Whatever the reason, participation could make a difference in a patient’s future, as well as in the lives of future cancer patients.

How Do I Know If I Should Participate in a Clinical Trial?
The decision to participate in a clinical trial is one that only you can make, with the help of your physician and the people close to you. If you are interested in participating in a clinical trial, you will be informed of the clinical trial’s potential benefits and drawbacks before making your decision. If the investigational drug is proven to be effective, you may be among the first to benefit. In addition, through your participation in a research study, you will also be helping future cancer patients.

Are There Risks Involved in Participating?
Because clinical trials are research studies, study drugs may not be better than current standard drugs or treatments. In addition, you may experience side effects that are worse than those of current standard drugs and treatments. Also, your health insurance company or managed care provider may not cover all of the patient care associated with a clinical trial. All of these factors should be discussed thoroughly with your physician and those close to you before deciding whether or not to participate in a clinical trial.

Where are the Trials Held?
Many clinical trials may be available right in your own community. Ask your physician for specific information or search on-line to find a current trial in your region.

How Do I Learn More About a Specific Clinical Trial?
Through a process called “Informed Consent,” you will learn the key facts about a particular clinical trial before making a decision about participating. Your doctor will explain the purpose and requirements of the study, including any potential drawbacks and benefits. If you agree to take part in the trial, you will be asked to review and sign a form that outlines the study’s details prior to participating.

How Do I Get More Information?
Consult your physician to find out whether or not there is a clinical trial that would be appropriate for your care or you may call our research coordinator, Jessica Gerlach, CCRP at 845-333-1133.

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. The IRB reviews and has authority to approve, require modifications in (to secure approval), or disapprove all research activities. This group review serves an important role in the protection of the rights and welfare of human research subjects. All protocols must be approved by the IRB prior to enrolling any study patients. Garnet Health Medical Center’s IRB is made up of an equal amount of hospital employees and community members.

Anyone interested in learning more about our clinical trials or the IRB may contact our research coordinator: Jessica Gerlach, CCRP (Certified Clinical Research Professional) at 845-333-1133 or jgerlach@ormc.org.