By Christy Kubin, BS, Data Architect (SEND), Brian Argo, BS, Data Architect (SEND), and Jamie Megna, BS, Data Architect (SEND)
SEND is the Clinical Data Interchange Standards Consortium (CDISC), Standard for Exchange of Nonclinical Data (SEND). It is an implementation of the Study Data Tabulation Model (SDTM) for nonclinical studies. This description is not particularly helpful to most people; therefore, we have outlined SEND in further detail, to include a history of the standard while discussing its impact on the industry.
Exciting developments in the area of data standards are poised to directly impact nonclinical data regulations in the near future. The CDISC developed the SDTM to outline a universal standard for the structure and content of datasets for individual clinical study data, and this standard is now being implemented for nonclinical data. The FDA has selected the SDTM as their accepted standard for data presentation; and eventually, all nonclinical data is expected to conform to this format. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released binding guidance on December 17, 2014 that sets requirements for the submission of SEND datasets.
These standards have been successfully implemented in the clinical area; directions for implementing SDTM for clinical data are outlined in the Study Data Tabulation Model Implementation Guide (SDTMIG). The guidance for implementing SDTM for nonclinical data is contained in the SEND Implementation Guide, which is commonly referred to as the SENDIG. SENDIG version 3.0 was released for use on June 20, 2011, following a successful three-year piloting period with the FDA. SENDIG 3.1 will be released on the CDISC website later in 2015.
A universal set of standards for nonclinical datasets is a groundbreaking development, as standardized data opens the door for data integration and more efficient regulatory reviews. While the original drive behind the SEND development was to allow the FDA to increase the quality and efficiency of their regulatory reviews, Sponsors have been quick to recognize the potential in-house benefits. One approach to leveraging the SEND standard is to create a data warehouse based on the SEND format. This warehouse will allow data import from multiple sources such as different CROs and in-house projects into one location. The standardized data format allows for querying and data analysis across a multitude of studies. It will also allow for more sophisticated, comprehensive historical controls. The availability of cross-study analysis, as well as historical controls, will support data-based decision making across the industry.
MPI Research is actively involved in SEND standards development and implementation, allowing us to ensure successful SEND dataset package creation for our Sponsors.