As the incidence of diabetes continues to rise, more and more children are being affected by this life-changing chronic condition. Research from the International Diabetes Foundation shows that 78,000 children develop type 1 diabetes every year, and the incidence of type 2 diabetes in the pediatric population is also on the rise, with type 2 now accounting for more than 10% of newly-diagnosed diabetes in children between the ages of 12 and 16 years. Moreover, at 18 years of age the incidence of type 1 and type 2 diabetes is nearly identical.

DiagnosisDespite the growing demand for treatment options, there is currently an unmet need for innovative, safe therapies to treat type 2 diabetes in the pediatric population. Many compounds have recently been approved or are in late-stage development for adults; however; pediatric trials are still in the planning phases or are just beginning. Biopharmaceutical companies who have initiated pediatric trials are contending with a limited patient population (the vast majority of type 2 patients are adults) that is inherently difficult to recruit. Recruitment difficulties are further exacerbated by competing trials and early phase study designs which offer no potential therapeutic benefit to the patient.

It is also vital to understand that the protocol for a study in adults cannot be adapted for children merely by changing the age of eligible participants. Designing a protocol for a pediatric clinical trial requires an understanding of developmental physiology, emotional maturity, and the particular clinical and pathologic manifestations of the disease being studied. Careful attention must be paid to the specifics of the protocol as they pertain to pediatric participants. Similarly, principal investigator and investigational site selection must consider suitability for and previous experience with pediatric clinical research. The ideal pediatric trial site understands the need to “enroll the family”, and offers facilities to occupy siblings and expanded hours to accommodate busy family schedules.

Quintiles’ white paper, Diabetes Drug Development: A Perspective on Pediatric Indication Planning, explores the specific clinical, design, and operational considerations for pediatric clinical trials that biopharmaceutical companies need to consider when conducting research in this therapeutic area.