To determine if a new investigational drug is safe and effective, some study volunteers may take medication; others may take a 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 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, that you can stop participation freely at any time and that you will be compensated for your time and travel.
As a clinical study volunteer, you may be asked to:
- Visit a health-care provider regularly
- Take medication
- Have laboratory and diagnostic tests
- Change your diet and exercise habits
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 office?
- What tests will I need?
- Is there a chance I will receive a placebo?
- Have other people been treated with this drug before in clinical studies?
- Will I continue to see my own personal doctor?
- What are my treatment options if I don’t participate in the 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 clinical study.