Newcastle University Reports Findings in Clinical Trial Research (Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration).

Newcastle University has collaborated with the conect4children (c4c) project and the Clinical Data Interchange Standards Consortium (CDISC) to develop the Pediatrics User Guide (PUG), which aims to standardize and reuse data in pediatric clinical trials. The PUG consists of cross-cutting data items that are routinely collected in pediatric clinical trials, addressing the lack of child-specific CDISC standards. The development of the PUG involved several stages, including scoping, modeling, and review. The PUG has been published on the CDISC website and is intended to facilitate efficient planning and delivery of pediatric clinical trials. The long-term use of the PUG will enable the pooling of data from multiple trials, which is particularly important for medical domains with small populations. [Extracted from the article]