Rationale
Vision
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 clinical 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.
Unmet Needs
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.
Benefits
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