Combining Patient Centricity And Commercial Viability In Pediatric Product Development

By Srinivasan Shanmugam, Ph.D., Adare Pharmaceutical Services

Pediatric clinical trials are challenging for a number of reasons, with availability topping the list. Given the diverse age groups within pediatric populations, recruitment and enrollment is difficult. Long-term study is impossible because of this patient group’s rapid growth and development — not only in terms of age but also anatomically and psychologically. Additionally, ethical considerations mark every step of a pediatric clinical trial.

Filling these gaps in knowledge is onerous, since ethical issues, patient population heterogeneity, limited blood sampling, and patients’ rapid growth all inhibit studies focusing on pediatric populations.

The strategy to overcome these challenges includes a combination of dose flexibility and accuracy, plus improved dose convenience through taste masking and easy-to-swallow formulations. A variety of taste-masking technologies and easy-to-swallow formats are available, including orally disintegrating tablets (ODTs), chewables, and “sprinkles.” Novel formats also play a significant role.