Only you can make the decision about whether or not to participate in a clinical trial. Before you make your decision, you should:
- learn as much as possible about your disease and the trials that are available to you.
- Then, talk about this information and how you feel about it with your doctor and/or nurse, family members and friends to help you determine what is right for you.
What are the potential risks and benefits of clinical trials?
Potential benefits include:
- Playing an active role in your own health care
- Gaining access to new research treatments before they are widely available
- Obtaining expert medical care at leading health care facilities during the trial
- Helping others by contributing to medical research
The potential risks include:
- Unpleasant, serious or even life-threatening side effects to experimental treatment
- Ineffectiveness of experimental treatment for the participant
- Requiring more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements
How are participants protected?
The government has a system designed to protect human research subjects. Before a government-funded clinical trial can begin, the trial plan (also called a protocol) must be approved. During the trial, review committees make sure that the plan is being followed and participants are being protected.
Regulations require the researchers performing studies to thoroughly inform patients about a study's treatments and tests and their possible benefits and risks before a patient decides whether or not to participate in any study. This process is called informed consent.
What is informed consent?
Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. In addition to talking about these facts with the research doctor or nurse, they will be included in a written consent form that you can take home to read and discuss. The consent form will include details about:
- the study approach
- the intervention given in the trial
- the possible risks and benefits
- the tests you may have
Don't hesitate to ask questions until you have all the information you need (see Participating in a Trial: Questions to Ask Your Doctor). While informed consent begins before you agree to participate in a trial, you should feel free to ask the health-care team any questions you have at any point. Informed consent continues as long as you are in the study. You can change your mind and leave the study whenever you want -- before the study starts or at any time during the study or follow-up period.
Could I receive a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
What happens during a trial?
If you decide to participate in a clinical trial, you will work with a research team. Team members may include doctors, nurses, social workers, dieticians, and other health care professionals. They will provide your care, monitor your health carefully, and give you specific instructions about the study.
Participating in a trial may mean that you might have more tests and doctor visits than you would if you weren't in the study. Team members also may continue to stay in contact with you after the trial ends. To make the trial results as reliable as possible, it is important for participants to follow the research team's instructions. That means having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.