The Standard for Exchange of Nonclinical Data (SEND) is the newly required format for submissions of nonclinical data to the US Food and Drug Administration (FDA) for carcinogenicity studies, and single and repeat dose toxicity studies. The framework of SEND was modeled after the Standard Data Tabulation Model which was established for clinical submissions. Both frameworks were created by the Clinical Data Interchange Standards Consortium (CDISC) with the goal of standardizing and digitizing data for the FDA reviewer.
SEND is not currently required for submission under the FDA Animal Rule. However, there is an increasing desire to use the SEND format for data visualization and warehousing purposes. Under the current SEND modeling paradigm, acute radiation syndrome (ARS) studies introduce several complications during the formation and review of the dataset. For example, SEND has no ability to include Day 0, which is counter to the traditional design of ARS studies that use Day 0 for challenge doses (i.e., day of radiation).
Additionally, modeling the challenge agent and test article within the Trial Domains are not demonstrated within the current guidelines, making best practices and standardization across different studies and sites nearly impossible. Since existing SEND guidelines do not contain Animal Rule domains, the framework will have to be modified to support ARS studies. SNBL USA is part of the CDISC Animal Rule team currently working on drafting guidance standards for Animal Rule studies. Once established, this guidance standard will be subject to FDA and public input prior to being issued as a requirement.