In collaboration with the FDA through a public-private partnership, the SEND Implementation for Cross-Study Analysis Initiative is pursuing the development of proposed solutions for the implementation and use of CDISC SEND data packages with the aim of facilitating cross-study analysis of preclinical trials. Open-source guidance on SEND as applied to study analysis, intended for use by CROs, regulators, and sponsors, has the potential to contribute to a broader knowledge base across early-stage R&D and support faster, more improved decision-making.
The CDISC SEND format is growing in adoption across the industry, but variability in its use/implementation prevents meaningful and accessible single-study analysis as well as cross-study analysis on a broader scale, limiting the potential value of SEND. An examination of SEND implementation variabilities, as well as existing challenges in the use of SEND data packages for analysis, is needed to enable meaningful analysis use cases.
With consistent SEND study data packages, Organizations can:
- More easily compare data generated across multiple studies, leading to more informed decision making to bring better compounds to patients faster
- Generate more efficient processes to deliver data leading to decreased cycle times for both CROs and Sponsors
- Reduce the need for sponsors and CROs to develop and maintain internal SEND standards
- Improve the quality of data sets and reduce errors to streamline Regulatory review and analysis
Learn About Our Progress & Get Involved
As we pursue the development of proposed solutions for the implementation and use of CDISC SEND (Clinical Data Interchange Standards Consortium) (Standard for Exchange of Nonclinical Data) data packages with the aim of facilitating cross-study analysis, we plan to share our progress through various public channels like manuscripts, Congress presentations, and forums as well as webinars and workshops. We invite you to read about our development work below and get information about upcoming events and progress by joining our mailing list.
- 2021 White Paper in PHUSE: Harmonization of SEND Implementation to Enable Historical Control Data Analysis, the Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology
- 2021 Manuscript in Chemical Research & Toxicology: Leveraging the Value of CDISC SEND Datasets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals
- The SEND Harmonization for Cross-Study Analysis team has published a second manuscript co-authored in collaboration with the FDA under the Public-Private Partnership in Chemical Research in Toxicology’s Computational Toxicology Special Edition (Chem. Res. Toxicol. 2021, 34, 2, 483–494).
- 2020 Manuscript in Regulatory Toxicology & Pharmacology: SEND harmonization & cross-study analysis: A proposal to better harvest the value from SEND data
- 2019 Luncheon & Overview, “SEND Harmonization Initiative Solutions to Enable Cross-Study Analysis”