Pediatric Trials FAQs
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Pediatric Trials FAQs
Q: Can children participate in clinical trials?
Yes. Clinical trials may be conducted in children of all ages from birth through adolescence. Like clinical trials in adults, pediatric clinical trials are research studies designed to answer specific questions about a new medical treatment, or new ways of using known treatments in children. Participation of a child (or pediatric subject) in a clinical trial follows the same rules as adults and are based on an inclusion/exclusion criteria. Additional safeguards may be required based on regulation or laws when children are participating in clinical trials to ensure the safe and ethical treatment of this population.
Q: How does assent differ from informed consent?
Granting “assent” expresses a willingness to participate in research by persons who are too young (as defined by law or regulation) to give informed consent but who are old enough to generally understand the proposed research, the expected risks and possible benefits, and the activities expected of them as subjects. If assent is granted, informed consent must still be obtained from the subject's parents or guardian.
Q: Can my child stop participating in a clinical trial?
Yes. You may withdraw your child from participation in a clinical trial or your child may decide to leave a clinical trial, at any time. When withdrawing from the trial, the parent or guardian should let the research team know about it, and the reasons for leaving the study.
Q: What should a parent consider before their child participates in a clinical trial?
Parents (or guardians) should consider as much as possible about the clinical trial and consenting to allow their child to participate in a clinical trial. Both the parents and the child should feel comfortable asking the health care team questions. In addition to the general questions listed for consideration before participating in a trial, parents should also consider the following questions:
- Will my child be able to cope with a trial?
- What if my daughter is of childbearing age?
- Could my child’s condition worsen during the trial? What will happen if it does?
- What will happen with my child’s treatment after the study ends?
- If my child’s treatment appears successful, can treatment continue after the study ends?
