Clinical trials in the pediatric population: an option or an obligation?28-04-2016
The working group of the European Medicines Agency (EMA), which was used to set the foundations for the Pediatric Regulation, determined that over 50% of the medications used in children had not been studied at all for potential effects of their administration to this age group, and that physicians often used medications authorized for adults, adjusting the dose based only on an individual's weights.
In order to ensure that products administered to the pediatric population have been specifically authorized for such use in proper pharmaceutical forms, a Pediatric Committee was created within the EMA, and, since the Pediatric Regulation entered into effect, companies must present data on the potential use of medications in minors based on a pediatric research plan approved by the Agency.
To compensate for any additional expenses incurred as a result of these measures, the conduct of clinical trials in minors may result in the granting of additional market exclusivity rights, as well as a six-month extension for the supplementary protection certificate, or the concession of two additional years to the 10-year period of commercial exclusivity of orphan medications. Furthermore, the concept of Marketing Authorization for Pediatric Use was introduced, which provides 10 years of exclusivity in the market for new pediatric indications for medications that are not protected by a patent.
At Bioclever CRO, we make available our wide experience in study design, start-up, management, monitoring, data analytics and clinical trial results exploitation also for the pediatric population to investigators and the pharmaceutical industry.