  Standardization of data items collected in paediatric clinical trials is an
important but challenging issue. The Clinical Data Interchange Standards
Consortium (CDISC) data standards are well understood by the pharmaceutical
industry but lack the implementation of some paediatric specific concepts. When
a paediatric concept is absent within CDISC standards, companies and research
institutions take multiple approaches in the collection of paediatric data,
leading to different implementations of standards and potentially limited
utility for reuse. To overcome these challenges, the conect4children consortium
has developed a cross-cutting paediatric data dictionary (CCPDD). The
dictionary was built over three phases - scoping (including a survey sent out
to ten industrial and 34 academic partners to gauge interest), creation of a
longlist and consensus building for the final set of terms. The dictionary was
finalized during a workshop with attendees from academia, hospitals, industry
and CDISC. The attendees held detailed discussions on each data item and
participated in the final vote on the inclusion of the item in the CCPDD. Nine
industrial and 34 academic partners responded to the survey, which showed
overall interest in the development of the CCPDD. Following the final vote on
27 data items, three were rejected, six were deferred to the next version and a
final opinion was sought from CDISC. The first version of the CCPDD with 25
data items was released in August 2019. The continued use of the dictionary has
the potential to ensure the collection of standardized data that is
interoperable and can later be pooled and reused for other applications. The
dictionary is already being used for case report form creation in three
clinical trials. The CCPDD will also serve as one of the inputs to the
Paediatric User Guide, which is being developed by CDISC.
