As a parent have you ever thought about the medicines that you give your children? Have they been proven as safe and effective? In reality, only about a quarter of all approved drugs marketed in the United States have had clinical trials performed involving pediatric patients. Doses for children are often merely adjusted for their smaller weight, but there are many other differences in children that can affect how drugs act in the body. The lack of pediatric testing and labeling can place children at risk of under- or over-dosing, and the lack of age-appropriate formulations, such as liquids or chewable tablets, can result in improper administration of drugs.
In the past ten years, however, studies have increased; and they are reporting important data. For instance, Ibuprofen which is commonly used to reduce fever and swelling had no dosing information for children less than 2 years of age, but studies in thousands of infants established a safe and effective dose in infants and children from 6 months to 2 years.
Studies with a marketed sedative, led to a new oral formulation for use in infants and children. In addition, the study results showed that this drug has a high risk for an adverse event in children with congenital heart disease and pulmonary hypertension. In the controlled setting offered by clinical research, it is possible to identify these side effects before they become life-threatening to the participants and that knowledge is applied for future labeling.
It may seem like a scary proposition to put your child on an “investigational medication” but most of the studies that are being done are testing medications currently approved at adult doses – and being given to children anyway!
Many physicians agree that the care received during a clinical study is higher than the normal standard of care because data is being collected that requires more extensive studies and more frequent visits. Of course, that translates to a little extra time and effort for the parents and the children, but your sacrifice could save a child’s life.
If your child has a serious condition, you may be more willing to consider a study in hopes of finding a cure. Even a healthy child can have an emergency or develop a disease requiring medication. Knowing that the proper measures had been taken to determine the safety and effectiveness in children would be comforting.
If you decide to consider taking part in a research study, always remember that you are a volunteer. Make sure that all your questions are answered before you agree to participate. Several sources on the internet tell you exactly what to ask; if you don’t feel comfortable, realize that you may withdraw at any time.
If you participate in a study, share with your child the importance of compliance and make them proud of the responsibility that they have taken on. Most importantly, let them know how proud you are that they are helping children in the future. Personally, I think it calls for ice cream!