Increasing number of data sources

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, and for clinical trial information, a software package is provided .

Sources of data used in this website

Topic (linked to source)OriginatorProgrammatically accessible (API) in PaediatricData.EUExample analysis in PaediatricData.eu
Paediatric investigation plans (PIPs)European Medicines AgencyYesEMA PIPs web app
Written Requests (WRs) for pediatric studies issuedFood and Drug AdministrationNo
Written Requests (WRs) for pediatric studies completedFood and Drug AdministrationYesFDA WRs
Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – presentFood and Drug AdministrationYesAssessments
Reviews of Pediatric Studies Conducted under BPCA and PREA from 2007-2012Food and Drug AdministrationYesAssessments
ClinicalTrials.gov pediatric drug trialsU.S. National Library of MedicineYesInnovation
Investigating adult cancer medicines in children
EU Clinical Trials Register paediatric trialsEuropean Medicines AgencyYesInnovation
Investigating adult cancer medicines in children
Assessment reports of paediatric data (Article 46)European Medicines AgencyNo
Assessment reports on paediatric dataCo-ordination Group for Mutual Recognition and Decentralised proceduresNo
Centrally authorised medicines European Public Assessment reportsEuropean Medicines AgencyYesInvestigating adult cancer medicines in children

EMA EPARs web app

References

Herold, Ralf. 2018. Ctrdata: R Package to Aggregate and Analyse Information on Clinical Trials from Public Registers. https://github.com/rfhb/ctrdata.