Supporting the Use of SEND for the Implementation of Virtual Control Groups
Project Description |
This project will draw on the PHUSE Nonclinical Topics Working Group’s extensive SEND expertise to develop best practices for populating SEND datasets with data from virtual control animals. As other initiatives continue to clarify how study design factors influence virtual control selection – such as the impact of anaesthesia protocols on rat electrolyte levels (Gurjanov et al., 2023) – the project will also define how these factors should be consistently represented within SEND. If gaps in the current SEND standard are identified, recommendations for CDISC updates will be drafted. Initially, the scope will focus on study types long established in SEND to ensure sufficient data for evaluating best practices. The team will also consider future needs for study designs not yet fully modelled in SEND. In parallel, the project will collaborate with the Nonclinical Scripts initiative to provide an open forum for sharing and hosting open‑source tools supporting virtual control selection and database infrastructure. |
Project Leads | |
|---|---|
Christy Kubin, Charles River Laboratories | |
Kevin Snyder, Certara | |
William Houser, Bristol-Myers Squibb | |
Alex Pearce, PHUSE Project Coordinator |
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