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What is a Clinical Study?
Before new treatments can be given to people who need it, a team of doctors and researchers must perform a clinical study to make sure the medicine
Is safe, and
Works well in people
Some studies might compare:
The study medicine
VS
Current treatment or placebo (looks like the study medicine but has no active ingredient)
These types of studies are usually randomized. This means that participants are placed in a treatment group by chance, similar to flipping a coin.
In some studies, all participants receive the same study medicine. However, they may be given different amounts (doses) of the study medicine based on age or weight.
Clinical studies are an important step in finding new and better treatments for people around the world!
All study medicines need to pass three clinical study phases:
Phase I
Small number of healthy people (e.g., 20-50)
How does the body react?
Highest tolerated dose?
Phase II
Larger number of people with a specific disease or condition (e.g., 50-100)
Does it work?
Short term side effects or risks?
Phase III
Largest number of people with a specific disease or condition (e.g., hundreds or thousands)
Gather more information about safety and how it works in people
Sometimes clinical studies may require fewer participants, especially for studies involving rare diseases.
What are the positives and negatives of participating in a clinical study?
Potential positives
- Frequent health checks
- Contribute to research to find a new treatment
- Help other people
Potential negatives
- Have side effects or other health risks
- Visits to the study clinic may be inconvenient
Pediatric clinical studies
- Designed for children under the age of 18
- Require that you, as the parent(s) or caregiver(s) of the child, agree to participate
What happens in pediatric clinical studies?
In clinical studies, patients:
- Receive the study medicine being tested
- Complete different medical tests that help doctors and researchers learn about the study medicine
- Are closely monitored to make sure it is safe for them to continue in the study
- Visit the study clinic regularly with their parent(s) or caregiver(s)
Before participating in a clinical study:
You, as the parent(s) or caregiver(s), need to read and sign an Informed Consent Form (ICF)
The ICF includes information about:
- What you and your child’s participation would involve
- Your rights as participants
- Depending on your child's age and your country requirements, your child may be asked to sign a similar form called an Assent form
The Assent form:
- Will be read by or to your child
- Describes the study in an easy-to-understand way
- Requires a signature or drawing by your child to confirm participation, or verbal agreement
- Joining a clinical study is completely voluntary. This decision requires careful consideration to ensure it is right for you, your child, and your family. Please speak to your doctor to learn more.