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“Children are not just small adults – their bodies work in very different ways and they often undergo many changes as they grow from infancy towards adolescence and adulthood. Because their bodies work differently, it’s important to create child-specific medicines and treatments instead of just modifying adult doses and therapies.”

- Clinical trials in children - World Health Organization

Children develop differently than adults, both mentally and physically. Each organ in a child’s body is growing and developing until they reach adulthood. At each stage of a child’s growth, they may need different doses or different treatment for a condition or disease.

Some diseases or conditions only happen in children, such as childhood cancers or premature birth. Clinical trials are needed to learn more about childhood diseases and their treatment. Vaccines also need to be tested in children once their safety and effectiveness has been seen in adults.

Clinical trials in children are designed to help sponsors:

  • Understand how new drugs and treatments may affect children
  • Find the best doses and treatment options for children at different ages
  • Develop different ways for children to get or take a treatment (for example, chew tablets or drink a liquid rather than swallow a pill)

How are clinical trials in children different?

Children and adolescents may respond differently to treatment than adults, so it’s important that studies are done in several age groups. Many times, treatments that have been approved for use in adults have not yet been tested in children. So, additional clinical trials are done to make sure new medicines or treatments work and are safe for children to take.

If you are considering a clinical trial as an option for the child in your care, ask the child’s doctor and the clinical trial staff questions. They can give you the information you need to decide if the clinical trial is the right choice. It’s also important to know that there are extra protections in place for children who take part in clinical trials.

Illustration of a bird talking to three rabbits

If you decide that your child should take part in a clinical trial, you will need to sign an informed consent form on your child’s behalf. Sometimes, clinical trial staff may talk to a child about the research and ask for their assent to take part, when appropriate. An assent is a way for the child or teenager to show that they agree to join the clinical trial. It does not replace the informed consent form that a parent or legal guardian signs. Involving a child in these discussions and obtaining their assent depends on their maturity and independence. Also, obtaining a child’s assent must be consistent with each country’s regulations.

In addition to the information you can find on our website, there are resources specifically for parents and legal guardians, like you. Please see our resources tab in the FAQs.

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THE PURPOSE OF THIS WEBSITE IS TO OFFER EDUCATION AND INFORMATION TO PATIENTS AND THEIR FAMILIES AND FRIENDS, THE PUBLIC, AND HEALTHCARE PROFESSIONALS ABOUT THE CLINICAL TRIAL PROCESS. IN ADDITION, THE WEBSITE WILL PROVIDE SPECIFIC INFORMATION ABOUT ASTELLAS CLINICAL TRIALS. PLEASE READ THE COMPLETE ASTELLAS TRANSPARENCY POLICY TO LEARN ABOUT THE CLINICAL TRIAL INFORMATION AVAILABLE ON THIS WEBSITE