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.

翻译：儿童临床试验中采集的数据项标准化是一个重要但具有挑战性的问题。临床数据交换标准联盟（CDISC）的数据标准已为制药行业广泛理解，但缺乏对某些儿童特有概念的实现。当CDISC标准中缺少儿童相关概念时，企业和研究机构在儿童数据采集中采用多种方法，导致标准实施方式不同，并可能限制数据的重用价值。为应对这些挑战，conect4children联盟开发了跨领域儿童数据字典（CCPDD）。该字典分三个阶段构建：范围界定（包括向10家工业伙伴和34家学术伙伴发送调查问卷以评估需求）、长清单创建以及最终术语集的共识构建。字典在一次研讨会上最终确定，参会者来自学术界、医院、工业界及CDISC。与会者对每个数据项进行了详细讨论，并参与将数据项纳入CCPDD的最终投票。9家工业伙伴和34家学术伙伴回应了调查问卷，显示对CCPDD开发的整体兴趣。在对27个数据项进行最终投票后，3项被否决、6项推迟至下一版本，并征求CDISC的最终意见。首个包含25个数据项的CCPDD版本于2019年8月发布。该字典的持续使用有望确保采集标准化、可互操作的数据，便于后续整合及用于其他用途。该字典已用于三项临床试验的病例报告表创建。CCPDD还将作为CDISC正在开发的《儿童用户指南》的输入之一。