Are Clinical Trials are Safe for Kids?

Many medicines and treatments are given to children that may have been tested only in adults.  According to the Children and Clinical Studies article “Why Do Research in Children?”, this occurs in more than 70 percent of cases. Research dedicated to children can help uncover the best doses, the development of medications that are easier for children to take yet are still safe and how medicines affect children as they grow and develop.

“For example, testing of one antibiotic showed that babies needed higher doses than older children to get rid of their infection. Many medicines are filtered out of the body and handled differently by a child’s developing kidneys,” continues the Children and Clinical Studies article.

How well and fast medications are absorbed, metabolized, and eliminated can vary among infants, children, teens, adults, and the elderly. Metabolism, body composition (weight, muscle mass), liver and kidney function, and digestive function vary as we age. Therefore, some diseases and conditions occurring in both children and adults but that act differently—such as arthritis, heart disease, and diabetes—need to be studied for each age group separately in order to ensure the treatments and medications that are developed work as expected.

But are studies safe?

There are risks associated with participation in a research study, such as side effects or ineffectiveness. But, laws require every clinical investigator to safeguard participants through strict rules regarding study plans or protocols and patient monitoring. The Institutional Review Board (IRB), made up of doctors, scientists, and citizens, must approve every single clinical trial in the United States and make sure that the risks are as low as possible. And, there are special regulations for studies involving children in place. According to a summary of these regulations posted by the Office for Human Research Protections, the IRB also considers the “potential benefits, risks, and discomforts of the research to children and assess[es] the justification for their inclusion in the research.” In short, the benefits need to outweigh the risks in order for the study to be approved.

Many trials are also closely supervised by a Data and Safety Monitoring Committee made up of experts who monitor studies as they are in progress. As further assurance, if your child is taking part in a Phase III study, you are trying a new treatment that is not available anywhere else and that
has been tested several times already.

In addition to all of the safety standards described above, all clinics have a thorough informed consent process that will ensure you know exactly what the trial is about, what is expected, what your rights are, and will give you the chance to ask questions so that you are completely comfortable and confident in the decision for your child to participate. If not, you can elect at any time to stop participating.

Per the National Institutes of Health (NIH), “groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research…As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.”

Meridien Research conducts a wide variety of clinical research studies at our six Central Florida clinics and needs you and your child! For more information or to see if you or someone you know may qualify to participate, please contact us today at 1-888-777-8839 or visit