Introduction: 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. Objective: To overcome these challenges, the conect4children consortium has developed a cross-cutting paediatric data dictionary (CCPDD). Methods: 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.Results: 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.Discussion and Conclusion: 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.
The pandemic is here to stay- evident from the second wave that is severely affecting global population. Though vaccination is now available, the population size restricts its efficacy, especially in the third world countries. Therefore, to avoid a third wave, natural preventive therapeutics are the need of the hour. In this work the efficiency of phytochemicals from <i>Withania somnifera</i> to bind to a total of six SARS-CoV-2 targets have been shown.1 µs molecular dynamics simulations and essential dynamic analyses shed light on the changes induced by the phytochemicals and highlights their multipotent capabilities- 27-Hydroxywithanolide B was able to bind to three targets. Relative free energy of binding for all the phytochemicals were calculated by MM/PBSA. Minimum energy structures were extracted from their free energy landscapes and were subjected to PSN-ENM-NMA and network centrality analysis. Results showed that the phytochemical binding changes the residue-residue interaction network. Network communities increase while hubs and links decrease. Metapath rewiring occurs through residues Phe456 in spike protein, Thr26 and Tyr118 in main protease, Val49 and Phe156 in NSP3, Leu98 in NSP9, Leu4345 in NSP10, Phe440 and Phe843 in NSP12. This work tries to understand the mechanism of possible inhibition by the phytochemicals to combat SARS-CoV-2 with their capability of targeting multiple proteins. The insight from this study can be of great relevance to explore the changes in network properties induced by reported potential inhibitors against SARS-CoV-2 targets.
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