Connect4Children (c4c), funded by the Innovative Medicines Initiative 2 Joint Undertaking, a public–private partnership between the European Union and the European pharmaceutical industry, has just released a publication on the need for standardized disease-specific data and reviewed multiple initiatives, data resources, and data standards that could be utilised for this purpose.
It is widely recognised that there are not enough medicines tested for all relevant ages of the paediatric population. To overcome this, it is imperative that clinical data from different sources are interoperable and can be pooled for larger post hoc studies. c4c has collaborated with the Clinical Data Interchange Standards Consortium (CDISC) to develop cross-cutting data resources that build on existing CDISC standards in an effort to standardise paediatric data. The natural next step was an extension to disease-specific data items. c4c brought together several existing initiatives and resources relevant to disease-specific data and analysed their use for standardising disease-specific data in clinical trials. Several case studies that combined disease-specific data from multiple trials have demonstrated the need for disease-specific data standardisation, and three relevant initiatives were identified. These include European Reference Networks, European Joint Programme on Rare Diseases, and Pistoia Alliance.
Check out the full publication here: https://www.mdpi.com/2306-5729/9/4/55