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A clinical study is research designed to test new investigational drugs, devices, or procedures to see if they work and are safe. This newsletter attempts to answer some key questions as you decide, with the assistance of your doctor and family, whether you should participate in a clinical study.
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
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.
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.
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?
- What were the results?
- Will I continue to see my own personal doctor?
- What are my treatment options if I don't participate in the study?
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