Aparito started its journey focused on the needs of paediatric patients with rare diseases and it’s part of our DNA. The Atom5TM platform played a key role in numerous paediatric studies and those studies enabled us to enhance and refine our platform’s array of capabilities that it boasts today. We understand that children’s needs can often be radically different from those of adults and the experience gained from years of children’s clinical trial support makes Aparito uniquely placed to aid researchers who work with paediatric populations.
Paediatric clinical trials
The paediatric medicines regulation was adopted in 2007 to encourage private companies and public institutions to develop adapted medicines for children from birth until 17 years of age.
“The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults” says the European Medicines Agency (EMA) of the regulation.
When planning clinical trials for the paediatric population, especially for rare diseases, the researchers need to take into account that children cannot be seen as small adults.
There is a wide range of “paediatric” populations with constantly evolving features including physiological, developmental, psychological and pharmacological until full maturation. Different efficacy profiles can be observed and safety reactions need to be carefully looked at to avoid severe or unexpected safety incidents for the child in particular for the vulnerable infants and neonates population.
In the Putting Paediatrics’ Needs First in Clinical Research webinar from Aparito and a panel of child health medical experts, different key aspects were discussed: the duty to conduct paediatric trials, the benefits of remote patient monitoring and how it could improve children’s healthcare (in particular with the COVID-19 pandemic) and the necessity of collaboration between all parties including researchers, regulators, healthcare professionals, patients and their parents would speed up the overall process.
Aparito’s work in paediatric clinical trials breaks a lot of new ground, from the use of remote video tools to evaluate the ability to ingest food for paediatric patients affected by a rare metabolic disease and Precision Management of epilepsy in South African children. Our regulatory knowledge, experience in paediatric trials, and our highly-configurable Atom5TM platform make Aparito perfectly placed to support paediatric clinical research.