During a clinical study, your child may be asked to take a medicine or undergo a procedure that is not part of their routine care plan. Some of these interventions can cause side effects. Identifying side effects is one of the reasons researchers conduct studies.
It's normal to be concerned about side effects your child could experience in a clinical study. Keep in mind that studies are designed to be as safe as possible, and your child will be carefully monitored for adverse reactions throughout the study.
How can I find out about potential side effects?
Before you enroll your child in a clinical study, researchers are required to tell you (and your child, depending on her age) about the possible risks of the intervention being studied. You're given an informed consent document to sign that contains this information. Read through the document carefully and talk it over with the study team if you have questions.
What kinds of side effects might my child experience?
Not all interventions cause side effects. If they do, not everyone experiences them or reacts in the same way. Your child's response to a medicine can depend on individual factors such as genetics and underlying health issues.
Potential side effects range widely depending on the type of study and intervention being tested. They may include minor problems such as headaches, nausea, diarrhea, sleepiness, or a rash. Occasionally, participants may have more serious problems such as liver or kidney damage, or even death.
In some studies, researchers give children an inactive treatment called a placebo (to compare with the study product) that's very unlikely to cause side effects. However, you and your child won't know it's a placebo.
What should I do if my child experiences side effects?
It's important to pay attention to any symptoms your child experiences or tells you about during the study. Report these to the study team immediately, starting from the date you sign the informed consent form, through the very last clinical study visit. This helps keep your child safe and provides researchers with important information about the intervention they're testing.
Your child's study team should be able to provide guidance on how to deal with milder side effects. However, if the side effects are severe, you may be asked to withdraw from the study. Remember, you have the right to remove your child from the study at any time. Refer to your informed consent document for resources on who to call if your child experiences an adverse reaction or if you want to leave the study.