Should I Participate in a Clinical Study?

What is a clinical research study?

A clinical study is research designed to test new investigational drugs, devices, or procedures to see if they work and are safe. This section attempts to answer some key questions as you decide, with the assistance of your physician and family, whether you should participate in a clinical study that tests a new investigational drug.

What can I expect if I participate in a clinical study?

To determine if a new investigational drug is safe and effective, some study participants may take medication; others may take placebo (sugar pill). If you decide to volunteer for a clinical study, you will learn about the potential risks and benefits of participating in a specific study when you review the study’s “informed consent” form with study personnel. You will also learn that you will be carefully monitored by doctors and nurses, that government health authorities and a medical ethics group will oversee the research, and that you can stop participation freely at any time.

As a clinical study volunteer, you may be asked to:

• Visit a health care provider regularly
• Take medication
• Have laboratory and diagnostic tests

Why are clinical studies important?

Almost all medications available today have gone through a clinical study. Because of clinical study research, we now have effective treatments for hundreds of diseases. Survival rates for breast cancer, HIV, and prostate cancer have all increased in the last decade due, in large part, to the research advances made by doctors and the participation of thousands of clinical study volunteers. Clinical study participants help researchers further the development of new treatments and new cures.

What are the benefits of participating in a clinical study?

Each study is different, but benefits of participation may include any of the following:

• Access to medication, medical care from specialists who know your condition, and laboratory services at no cost.
• An opportunity to receive a medical treatment that is not widely available.
• Knowledge that you are helping advance medical science.

What are the potential risks of participating in a clinical study?

While there is much to be gained by participating in a study, there are some potential risks as well:

• Side effects from the medication may occur
• In some studies you may receive a placebo, which contains no actual medication
• There are no guarantees that treatment will work.

You should carefully consider both the benefits and the risks of participation before enrolling in a study, as well as speak with your doctor.

What questions should I ask?

Choosing to participate in a clinical research study is an important decision. Here are some questions you may want to discuss with your doctor and your clinical study team:

• What is the purpose of this study?
• What are the potential benefits, and are there any foreseeable risks or discomforts?
• How long will I be in the study?
• How often will I need to visit the clinical/hospital?
• What tests will I need?
• Is there a chance I will receive a placebo in the study?
• Have other people been treated with this drug before in clinical studies? What were the results?
• Will I continue to see my own personal doctor?
• What are my treatment options if I do not participate in the study?
• Will there be any costs to me?
• Will I learn of the study results? If so, when?
• How many volunteers will participate in the study?
• Will my medical records remain confidential?

We encourage you to contact your doctor to discuss getting involved in a clinical study.