The Importance of Pediatric Clinical Trials
Children are constantly changing and growing. At each of the stage of growth, children may need different doses of medicine, different sizes of devices or different types of therapy. An 11-month-old’s body is going to handle medications completely different from the way a 6-year old or an 18-year old’s body will.
Pediatric clinical trials help us research medications on specifically aged children. With Pediatric medical research, the more precise the research study, the more effective the desired result.
There are many examples of pediatric clinical research. A common clinical research study on children are vaccine studies that help find a treatment for existing or new diseases in order to improve the health of children in the future.
If you are considering putting your child in a pediatric clinical trial it is important to have a general understanding of the phases of the research study. Pediatric clinical trials have 4 study phases:
Pediatric Clinical Trials Phase I
Researchers test a new medication in a small group of people for the first time to evaluate safety, determine safe dosage and identify side effects. This research is usually done first in healthy adult volunteers.
Pediatric Clinical Trials Phase II
Taking part in Phase II has fewer risks than Phase I, by this point researchers will have more information on the medication than in Phase I. This phase will be done on a
larger group of healthy volunteers. Researchers will be looking for minor side effects of the medication, how well it works and possibly alternative methods of administering the medication.
Pediatric Clinical Trials Phase III
Phase III will be conducted on an even larger study group, with the purpose to compare to the most commonly used medication for treatment. Much more is known about the medication at this point. Researchers will be studying if the medication is more effective than existing treatment, how the side effects compare to existing treatment and the long term benefits of the medication.
Phase III studies are randomized, meaning the pediatric patients are split into 2 or more groups. Each group receives a different treatment to compare the new medications to other methods of treatment.
Pediatric Clinical Trials Phase IV
This phase of the clinical trial is done after the FDA has approved the medication to be marketed, these studies are to continue collecting information on the long term use of the medication on various populations.
JBR Clinical Research is the leader in Pediatric Clinical Trials in Utah. For more information about current pediatric research studies, please visit our current pediatric study pages: Pediatric Vaccine 4 to 6 Year Olds and Pedatric Meningitis Vaccine or Children’s Dental Procedure. You may also call us directly at 801-261-2000.