Here are the sources of information that are used for PaediatricData.EU and for related publications. As the website is further developed, data will be extracted from further sources and combined to create a unique set of information with added value. This work should be relevant and interesting for patients, parents, health professionals, institutions or organisations.
For more insights and technical access, an application programming interface (API) can be provided upon request to access some of the data sources. In addition, a software package is provided for accessing protocol- and result-related information on clinical trials in public registers .
Sources of data used in this website
|Topic (with link to source)||Originator||Programmatically accessible (API) in PaediatricData.EU||Example analysis in PaediatricData.eu|
|Paediatric investigation plans (PIPs)||European Medicines Agency||Yes||EMA PIPs web app (updated daily)|
|EU Clinical Trials Register paediatric trials||European Medicines Agency||Yes (protocol- and results-related information for all trials in the register)||Investigating adult cancer medicines in children|
|Assessment reports of paediatric data (Article 46)||European Medicines Agency||Yes||EMA EPARs web app (for centrally authorised products; updated daily; tab Assessment reports)|
|Assessment reports on paediatric data||Co-ordination Group for Mutual Recognition and Decentralised procedures||No|
|Centrally authorised medicines European Public Assessment reports||European Medicines Agency||Yes||Investigating adult cancer medicines in children|
EMA EPARs web app (updated daily)
|Written Requests (WRs) for pediatric studies: List of Determinations and List of WRs issued||Food and Drug Administration||Not yet||FDA WRs|
|Reviews of Pediatric Studies Conducted under BPCA and PREA: from 2012 to present and from 2007-2012||Food and Drug Administration||Not yet||FDA Assessments|
|ClinicalTrials.gov pediatric drug trials||U.S. National Library of Medicine||Yes (for all trials and information in the register)||Innovation|
Investigating adult cancer medicines in children