The mission with the PaediatricData.EU website is ultimately to promote progress of medical research and treatment development for children through showing how changes proposed by established stakeholders translate into practice, and through more quantitatively informing further policies.
Thw website was created to present ideas about how to evaluate the progress in treating children with a serious disease, in particular children with cancer. For children with cancer, progress in outcomes is a long-standing issue. Children require specific medicines for their specific diseases. The approach has reversed, from protecting children from research and preventing them from experiencing its benefits, to now protect children through research and participation. (See discussion for example in .)
Examples of indicators described in this website show the complexities in improving outcomes for children and in measuring progress. (See for other sets of indicators for example ).
Feedback and suggestions are welcome and invited with the form below.
Expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. 2017. “Ethical Considerations for Clinical Trials on Medicinal Products Conducted with Minors.” https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2017_09_18_ethical_consid_ct_with_minors.pdf
“The European Roadmap to Horizon 2020 for Children and Adolescents with Cancer - A Long Term Sustainable Strategy.” 2015. SIOPE - the European Society for Paediatric Oncology. March 20, 2015. https://www.siope.eu/2015/03/20/the-european-roadmap-to-horizon-2020-for-children-and-adolescents-with-cancer-a-long-term-sustainable-strategy/
European Medicines Agency. 2017. “10-Year Report to the European Commission - General Report on the Experience Acquired as a Result of the Application of the Paediatric Regulation.” https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/paediatrics_10_years_ema_technical_report.pdf
Nuffield Council on Bioethics. 2015. “Children and Clinical Research.” Nuffield Bioethics. May 2015. http://nuffieldbioethics.org/project/children-research/
Rössig, C, H Juergens, M Schrappe, A Moericke, G Henze, A von Stackelberg, D Reinhardt, et al. 2013. “Effective Childhood Cancer Treatment: The Impact of Large Scale Clinical Trials in Germany and Austria.” Pediatric Blood & Cancer
60 (10): 1574–81. https://doi.org/10.1002/pbc.24598
Bourgeois, Florence T., Srinivas Murthy, Catia Pinto, Karen L. Olson, John P. A. Ioannidis, and Kenneth D. Mandl. 2012. “Pediatric Versus Adult Drug Trials for Conditions With High Pediatric Disease Burden.” Pediatrics
, July. https://doi.org/10.1542/peds.2012-0139