This Research Topic is introduced and supported by the European Paediatric Translational Research Infrastructure (EPTRI).
As evidenced by the COVID-19 pandemic and officially underlined by the US- Centers for Disease Control and Prevention "a child’s health is the public’s health" and ‘investing in more effective & safe paediatric drugs and other health products will have a massive positive impact on subsequent adult health’.It is well-known that children’s bodies are different from adults' and can be affected differently by drugs, especially in the long term, which requires ad hoc studies and research. On the contrary, until now only about 35% of medicines have been approved to be used in children and only a fraction of registered clinical trials have been devoted to paediatric patients. This discrepancy has been mainly attributed to the lack of funding (public and private) and several barriers encountered to completing developmental studies and trials tailored to children.
However, in more recent years, the US and EU Paediatric Regulations, including the obligation to submit paediatric investigational plans (PIPs), the development of official and scientific guidelines, and important international initiatives supporting paediatric research have stimulated an increasing number of paediatric studies as well as a significant increase in the interest of academia and industry to set up new technologies and methods for paediatric drug development. The FDA reports that there are more studies conducted on children in the last few years than in the previous 30 years combined. Moreover, in the premises of the ongoing revision of the Paediatric Regulation, the European Commission noted that an increasing number of Paediatric Investigation Plans (PIPs) have been agreed and completed, allowing more paediatric studies and clinical trials including children conducted in the EU.
In this Research Topic, we aim to contribute to the international progress in paediatric research by supporting and facilitating the publication of high-quality studies on a variety of aspects of drug development that can have an impact on children’s therapeutics and health.
The Topic will encompass a range of article types including original research, conceptual and systematic reviews, meta-analyses, mini-reviews, clinical reports, case studies, perspective articles, article commentaries, and opinion articles, discussing and describing the results of:
1. Basic and pre-clinical research that provides new knowledge on human growth and ontogeny influencing drugs effects and drug development
2. Research on new biomarkers targeting common or rare paediatric diseases or diseases that can affect children as well as adults
3. Research on technologies, standardised models, and analytical tools/IT tools that can be applied in a paediatric setting (drugs and medical devices)
4. Modelling, simulation, and extrapolations methods applied to paediatric medicines developmental phases mainly devoted to the right dose identification and risk/benefit preclinical evaluation.
5. Innovative paediatric-tailored formulations, including 3D applications
6. Investigation & scrutiny of clinical and RWD data on the use of medicines in children and adolescents.
7. Research on the ethical and legal framework for paediatric studies including the consenting process, raising awareness and improving patients engagement in paediatric research
This Research Topic is introduced and supported by the European Paediatric Translational Research Infrastructure (EPTRI).
As evidenced by the COVID-19 pandemic and officially underlined by the US- Centers for Disease Control and Prevention "a child’s health is the public’s health" and ‘investing in more effective & safe paediatric drugs and other health products will have a massive positive impact on subsequent adult health’.It is well-known that children’s bodies are different from adults' and can be affected differently by drugs, especially in the long term, which requires ad hoc studies and research. On the contrary, until now only about 35% of medicines have been approved to be used in children and only a fraction of registered clinical trials have been devoted to paediatric patients. This discrepancy has been mainly attributed to the lack of funding (public and private) and several barriers encountered to completing developmental studies and trials tailored to children.
However, in more recent years, the US and EU Paediatric Regulations, including the obligation to submit paediatric investigational plans (PIPs), the development of official and scientific guidelines, and important international initiatives supporting paediatric research have stimulated an increasing number of paediatric studies as well as a significant increase in the interest of academia and industry to set up new technologies and methods for paediatric drug development. The FDA reports that there are more studies conducted on children in the last few years than in the previous 30 years combined. Moreover, in the premises of the ongoing revision of the Paediatric Regulation, the European Commission noted that an increasing number of Paediatric Investigation Plans (PIPs) have been agreed and completed, allowing more paediatric studies and clinical trials including children conducted in the EU.
In this Research Topic, we aim to contribute to the international progress in paediatric research by supporting and facilitating the publication of high-quality studies on a variety of aspects of drug development that can have an impact on children’s therapeutics and health.
The Topic will encompass a range of article types including original research, conceptual and systematic reviews, meta-analyses, mini-reviews, clinical reports, case studies, perspective articles, article commentaries, and opinion articles, discussing and describing the results of:
1. Basic and pre-clinical research that provides new knowledge on human growth and ontogeny influencing drugs effects and drug development
2. Research on new biomarkers targeting common or rare paediatric diseases or diseases that can affect children as well as adults
3. Research on technologies, standardised models, and analytical tools/IT tools that can be applied in a paediatric setting (drugs and medical devices)
4. Modelling, simulation, and extrapolations methods applied to paediatric medicines developmental phases mainly devoted to the right dose identification and risk/benefit preclinical evaluation.
5. Innovative paediatric-tailored formulations, including 3D applications
6. Investigation & scrutiny of clinical and RWD data on the use of medicines in children and adolescents.
7. Research on the ethical and legal framework for paediatric studies including the consenting process, raising awareness and improving patients engagement in paediatric research