Did you know that 80% of rare diseases impact children – and many of these are in the dermatological therapeutic area? Sadly, several rare, dermatological conditions impact children who may never live to adulthood without early intervention. In delaying treatment, these pediatric patients cannot always recover the loss of function if the skin cells die. So, not only is it important for drug developers working on new treatments for dermatologic diseases that affect children to include them in the clinical trials for new drugs, it is now mandated by the FDA. However, including children presents its own set of operational challenges.
Dermatology trials are somewhat unique, and even more so with children included in the trial. Let’s discuss some of the key considerations that should be taken into account when planning rare, dermatologic trials for children.