The Food and Drug Administration (FDA) reports that only about 20 percent of drugs are currently labeled for pediatric use, despite the fact that children respond to drugs differently than adults. So by necessity, pediatricians often prescribe drugs to children that have not yet been approved for use in children. This is why pediatric clinical trials are so important. Without adequate, well-controlled pediatric clinical trials, we can’t be sure that our children are being prescribed safe and effective drugs at the proper dosage.
Pediatric studies are critical to the future of healthcare, which is why clinics are working hard to make these studies as safe, comfortable, and beneficial as possible for participants.
Why Pediatric Clinical Research Is So Important
The fact that most drugs prescribed for children have not been tested in children is enough to give any parent pause. No caregiver wants to rely on inaccurate data when approving their child’s treatment plan.
Pediatric clinical research is key to developing treatments for childhood disease and illnesses. Since so few products are labeled for pediatric use, doctors often find themselves making difficult choices when it comes to treating childhood illness, including prescribing drugs designed and licensed for adults to children without adequate safety and dosing data. Successful pediatric clinical studies have the potential to create new standards of care, increase dosage accuracy, and potentially even save lives.
How Pediatric Clinical Research Works
Pediatric clinical trials range from very small pilot studies to large nationwide studies. Many studies compare the effects of a new drug with those of a placebo or existing treatment. Some studies are also targeted toward the hyper-specific age range of the intended drug; for instance, if drug manufacturers hope to target infants with a drug, then the drug must be tested on infant participants.
To learn about the necessary components of a successful pediatric study, review the FDA’s General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.
Overcoming Pediatric Research Challenges
Pediatric studies present unique challenges and must be carefully designed to ensure both patient comfort and data viability.
Challenge #1: Communicating with Participants and Their Families
Many parents have concerns about pediatric research outcomes and safety, so patient care coordinators must work to clarify all trial procedures for families, explaining the process in clear terms for both the parent and the child.
If you’re considering participating in a clinical trial, feel free to ask as many questions about the study as you like. Your patient care coordinator will be ready to answer all of your (and your child’s) questions about the study’s protocols and goals. Rest assured that you will hear thorough explanations of all the procedures involved before you sign your child up for the study.
Challenge #2: Scheduling Conflicts
Between the child participant’s school schedule and parents’ work schedules, making time for pediatric research trials can be challenging. Fortunately, clinics may be able to accommodate scheduling conflicts by conducting research during school breaks, after school, and even on weekends. In addition, some studies limit visits to the clinic to make the schedule easier for children and their parents. For example, a child participating in a trial involving ADHD management may be asked to record journal entries at home instead of making frequent visits to the clinic.
Challenge #3: Participant Comfort and Support
When a child is unwell, the child and his or her family often must deal with a great amount of stress, anxiety, and discomfort. For this reason, pediatric studies should be designed to maximize participant comfort and convenience. Ideally, the family will find the clinic’s environment warm and welcoming. Patient care coordinators should work hard to make the experience pleasant and positive for everyone involved, including the parents and siblings of participants. Some clinics may provide special designated areas at the clinic for relaxation, playtime, or work.
Pediatric clinical research is a key part of making medical treatments safer and more comfortable for children and adolescents. Clinics like QPS work to overcome challenges like caregiver communication, scheduling conflicts, and patient comfort to make trials as stress-free as possible for everyone involved. With the help of willing participants, pediatric trials have the potential to transform pediatric medicine and save lives.
Have you ever thought about participating in a clinical trial? You could be a part of history! And QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted over 1,000 FDA-regulated studies, paying out over $35 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical trial.
To get started, you simply need to fill out an online application. Within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.