Clinical trials in children

Why would I consider a clinical trial for my child?

As a parent, nothing is more important than the wellbeing of your child. If they have a condition or disease, you may be exploring all possible options for them. If you’re considering a clinical trial, you may be weighing the potential benefits against the potential risks. Let’s take a closer look.

Potential
benefits

  • Participant safety is taken very seriously and your child’s health would be monitored very closely
  • Results of the trial may improve knowledge about the condition being studied

Potential
disadvantages

  • Clinic visits can be time consuming
  • Some of the assessments involved may be uncomfortable for your child
  • The potential new treatment being tested in the trial may not work better than currently available treatments
  • Your child may experience side effects from their assigned trial drug

If enrolled in a clinical trial, participants may not all receive the investigational drug. Some may receive a placebo – a substance that looks like the investigational drug but does not contain the active drug.

Why do we need children to take part in clinical trials?

  • Potential new treatments for children cannot be approved using the results of trials involving adults
  • Effects of treatments on the body can vary with age and weight, and may vary depending on the child’s stage of growth and development
  • The same condition may affect children and adults differently
  • Some conditions only affect children
  • The way adult treatments are given is not always suitable for children. For example, many children find it easier to swallow a liquid than a tablet. Trials help us find out if the investigational drug is generally safe and effective in different formulations

How would my child’s health be protected?

Regulatory authorities make sure that the rights of your child are protected:

  • All clinical trials are approved and monitored by special committees called Institutional Review Boards (IRBs) or Ethics Committees (ECs). These are independent committees responsible for:
    • Reviewing the trial design, the information you and your child are given before you agree to take part, how your child is recruited for the trial, and any other written information given to you and your child
    • Monitoring aspects of a trial and making sure that any serious changes in your child’s health are reported
  • The health of your child would be closely monitored throughout a trial
  • If your child’s health got worse while they were taking part in a trial, the trial team would discuss options with you and your child
  • Your child could leave the trial at any point and their usual care would not be affected

How would the consent process work for my child?

Children can take part in a clinical trial if (and only if) their parents or legal guardians give informed consent on their behalf.

Children who are seven years old or older may be required by local regulatory bodies to give their assent – to make sure that they understand what will happen during the trial and to let them know that they don’t have to take part and can leave at any time. By giving their assent, they’re agreeing to take part in the trial. This is in addition to the informed consent given by parents or legal guardians.

How would my child’s privacy be protected?

All health information, personal data, and trial data are confidential and secure.

Only the trial team – people hired to perform or manage the trial – would be able to see personal data.

Any data shared with the company conducting the trial would not include you or your child’s personal information.

Immigration status is generally not collected in clinical trials and won’t be collected in any Biogen clinical trial.

Could taking part in a clinical trial interfere with my child’s education and/or participation in extracurricular activities?

This could vary, depending on the place where the clinical trial visits take place. Some sites may offer flexible appointments to avoid disrupting your child’s normal routine. If you’re interested in your child taking part in a trial, be sure to ask about this, especially if it would affect your decision.

Where should I go next?

For more information on children taking part in clinical trials, please visit the following:
Find a trial

If you or the person you care for are interested in finding a trial.

SEARCH NOW
Medical conditions

Find out more about our research for a specific condition.

LEARN MORE

Explore information about pediatric research outside of Biogen Trial Link:
iactc.org

The Institute For Advanced Clinical Trials For Children.

VISIT WEBSITE
icanresearch.org

ICAN – The International Children’s Advisory Network.

VISIT WEBSITE