Frequently Asked Questions

Medical advances and improvements to clinical care have been made possible by clinical trials and the participation of volunteers. While there are many benefits to participating in clinical trials, there can also be risks, which is why it is important to speak with a physician before deciding to participate.

Below are answers to frequently asked questions about clinical trials so you and your family can make the most informed decision.

Download a pdf of our Frequently Asked Questions

What is a clinical trial?

A clinical trial is a form of research that uses human volunteers (called participants) to help answer specific questions about new ways to prevent, diagnose and treat diseases. Clinical trials are extremely important because they allow researchers to work with patients suffering from the exact condition they are trying to treat.

What types of clinical trials are available?

There are several forms of clinical trials. Some trials test new drugs, procedures or other treatments, and others look for better ways to prevent diseases in people who have either never had a disease or are trying to keep one from coming back. Diagnostic trials are used to develop better ways to diagnose a particular disease or condition; screening trials help identify the best way to detect certain health conditions. Other trials help find ways to improve the care and quality of life of people with long-term illnesses and diseases.

What do the different phases of trials mean?

Clinical trials take place in “phases,” and each phase helps researchers answer specific questions.

Phase I: These trials are used to test brand new drugs, devices or procedures to find out how safe they are and identify possible side effects. They usually involve 20 to 80 people.

Phase II: These trials are used to further evaluate the effectiveness and safety of a drug, device or procedure. The researchers keep track of any medical benefits, as well as side effects. They usually involve 100 to 300 people.

Phase III: These trials compare a new treatment or procedure to existing treatments to figure out which works best. Evaluation of side effects and effectiveness continues. They usually involve 1,000 to 8,000 people. 

Phase IV: Once a drug or procedure is approved by the U.S. Food and Drug Administration (FDA) and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment. 

Who participates in clinical trials?

Both people in good health and people with certain diseases or conditions participate in clinical trials. They do this to help researchers find better treatments. People may also participate to receive care or treatment only available as part of a clinical trial.

How does clinical research make a difference?

Clinical research helps us learn about the safety and effectiveness of all drugs, procedures and other treatments. Medical advances like new drugs and surgical procedures are made possible because of clinical trials and the voluntary participation of individuals.

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

It is important to understand that all medical research involves some amount of risk. Since risks and benefits are different for each clinical trial, make sure you talk to members of the research team before making a decision. They can tell you about the known risks and benefits of the trial, as well as other available treatment options to help you and your loved ones decide whether or not to participate.

Why should I consider participating in a clinical trial?

If you suffer from a health condition, have a personal interest in research or simply would like to improve the care of patients in the future, participating in clinical trials may be for you. Keep in mind that participation is voluntary, so if you change your mind at any point during the study, you have the right to stop participating. Just make sure to talk to your doctor first.

How do I find out if there are clinical trials for a specific condition or disease?

All clinical trials include guidelines about who can participate, called eligibility criteria. It is best to talk with your doctor before enrolling in a clinical trial. He or she can help figure out whether or not you are eligible to participate. In addition to the specific disease or condition, other guidelines may include age, gender, previous treatments, and other known medical conditions or family medical history.

What questions should I ask if I am thinking about participating in a clinical trial?

The National Institutes of Health provides a list of questions a person should ask when considering taking part in clinical trials. You can find this list by visiting www.nih.gov/health/clinicaltrials. While there may be benefits to participating in clinical trials, there can also be risks, so it is important to talk with a physician before deciding to participate.

Where else can I find information about clinical trials?

There are several websites that provide information about clinical trials, including:

National Institutes of Health websites: www.nih.gov and www.clinicaltrials.gov

The Winship Cancer Institute of Emory University: www.winshipcancer.emory.edu 

National Cancer Institute: www.cancer.gov/clinicaltrials 

Emory Institutional Review Board: www.irb.emory.edu/participants 

How can I find out more about clinical trials offered at Emory?

Emory clinical trials are available on the National Institutes of Health website. You can find cancer-related clinical trials at the Winship Cancer Institute of Emory University.

For more information on clinical trials at Emory Healthcare, please ask your Emory physician or call the Emory HealthConnection at 404-778-7777.