- What are clinical trials?
- Are there benefits to being a part of a clinical trial?
- Who is eligible?
- What is informed consent?
- What questions should be asked?
What are clinical trials?
Before any new medicine or medical device is placed on the market, it must be tested through clinical trials. Clinical trials are research studies, which require the participation of volunteer children, adults, and families. Results are then reviewed to determine if the drug, practice or medical device should be made available to the public. Clinical trials are a vital part of scientific research that play an important role in the development and evaluation of new medicines, treatments, and cures.
Are there benefits to being a part of a clinical trial?
Although the benefits vary according to each trial, there are some common advantages to being part of a clinical trial.
- may receive a new and promising drug that is not yet on the market
- may experience an improvement in their condition
- will receive thorough medical attention and testing at no cost
- will receive medication at no cost
- will learn more detailed information about the new medicine and the condition that it is treating or preventing
Who is eligible?
There are set criteria for entry in each clinical trial. The study physician will review you or your child’s history and the current clinical trials to see if he or she meets these criteria to enter a trial. Even if the selection criteria are met, the decision to enter a clinical trial is entirely up to you and your child.
What is informed consent?
From the beginning, the researcher will provide information, answer questions about the study and will continue to give updates during the study.
You will be given a consent form that outlines the study. If your child is old enough to understand he or she will be fully involved in the consent process. It is important to read the information and the consent carefully and understand the potential risks and benefits before signing. You (and your child if he or she is old enough to understand) decide if participating is the right thing to do. To protect everyone’s privacy, names and other personal information are kept confidential. You and your child can also change your mind about being in the study and withdraw at any time without any consequences to current or future care provided to you or your child.
What questions should be asked?
Before you enroll yourself or your child in a clinical trial, the study should be fully explained to you. Don’t be afraid to ask questions and learn about your and your child’s options. For example:
- What is the purpose of the study?
- What is required of me or my child?
- How long is the study?
- What tests are involved?
- What are the other choices for treatment if we don’t enter the study?
- What side effects might there be?