Clinical trials in the pediatric population: an option or an obligation?28-04-2016
The pediatric population includes from newborns to adolescents, and each subpopulation has different biological and pharmacological characteristics, which means that adapting clinical research based on age groups considerably increases the costs of drug development and authorization.
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.
Therefore, the submission of a Pediatric Research Plan together with a Marketing Authorization Application for a new medication is not an option but an obligation, having to regularly notify compliance, whether it is considered appropriate to postpone clinical trials in children until obtaining data in adults or, in the case of indications in which pediatric research does not apply, justify the reason for this exception.
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.