One of the major challenges in conducting clinical trials in children, especially in rare and orphan diseases, is the limited availability of patients and reluctance of many parents and caregivers to enroll their child in a trial with an experimental therapy. Read more about the FDA and EMA concept of pediatric extrapolation to minimize the number of children that need to participate in a clinical trial.
Overall, the progress made to date in pediatric clinical research is encouraging. However, there is still room for progress to be made to enable more approved drugs to be brought to market that will help to control diseases in children, as well as offer potential cures. With collaboration of regulators and stakeholders on the rise they are also working to make more pediatric medicines available to children who need them.
Dermatology trials are somewhat unique, and even more so with children included in the trial. This article discusses some of the key considerations that should be taken into account when planning rare, dermatologic trials for children.
Pediatric PK/PD modeling and simulation techniques are cornerstones of pediatric drug development. Read how PK/PD and other approaches to pharmacometrics address challenges of limited availability of suitable patients and parents’ inherent reluctance to expose children to unknowns.
Pediatric development plans are a requirement for all new medicines, indications, dosing forms, regimens, and routes of administration, and pediatric clinical research is on the rise. You need a partner who understands the compassionate, specialized clinical and regulatory expertise required when working with vulnerable pediatric populations and their families.