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Optimizing the Use of Data Standards |
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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data StandardsWorking Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here. ‘CTCAE Upversioning – When should a sponsor organisation decide to upversion CTCAE, DAIDS, or any other toxicity grading standards? How should sponsors handle pooled analyses with varying grading scales?' Do you have a (FAQ project based) question? Send your questions to the team by emailing workinggroups@phuse.global. |
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Capturing Computational Workflows in Clinical Trials with BioCompute |
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The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group has published a new white paper, Capturing Computational Workflows in Clinical Trials with BioCompute which is now open for public review. This white paper explores how the BioCompute standard is being applied in real-world clinical trials, showcasing practical case studies that demonstrate its role in improving reproducibility, transparency, and regulatory communication across complex computational workflows. The team welcome feedback on the paper by 6 March . Please send responses to workinggroups@phuse.global. |
Framework for Integrating Omics Data with Other Clinical and Non-Clinical Data Sources |
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The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group has published a new white paper, Framework for Integrating Omics Data with Other Clinical and Non-Clinical Data Sourceswhich is now open for public review. This white paper proposes a framework for integrating multi-omics data with clinical and non-clinical datasets, combining BioCompute for workflow documentation and MultiAssayExperiment (MAE) for data management. It aims to improve standardisation, interoperability, and reproducibility to better support personalised medicine and regulatory use. The team welcome feedback on the paper by 31 March . Please send responses to workinggroups@phuse.global. |
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