The CDISC SEND team have several new standards edging their way towards publication.

The SENDIG-Genetox is the CDISC SEND standard for the representation of in vivo genetic toxicology studies. This has completed an internal CDISC review and should soon be heading to a full public review. For those unaware, this first version of SENDIG-Genetox focuses on in vivo Micronucleus and in vivo Comet assays.

Currently in internal CDISC review, and also on the path towards its public review, is version 1.0 of the SEND Tumor Combinations. While not an Implementation Guide, it has been produced at the request of the FDA.  It was created by a working group of biopharmaceutical experts from the Society of Toxicologic Pathology, FDA, and members of the CDISC SEND team. Its primary goal is to assist pharmacology/toxicology reviewers and biostatisticians in statistical analysis of nonclinical tumor data. It is a spreadsheet to provide a user-friendly, high level hierarchy of tumor types or categories correlating the tumor names from the INHAND publications with those available in the NEOPLASM CDISC Controlled Terminology code list in SEND.

Further along in its publication process we have the SENDIG-DART v1.2. Regular readers will be well aware that I lead the CDISC team that produced this next version of the SEND standard for DART studies. This version was created in direct response to the FDA’s ‘Scope of SEND’ section of their study data Technical Conformance Guide. That addition by the agency let the industry know that juvenile toxicology studies are in scope of the SEND requirements. However, for studies where the data need to be analyzed by the postnatal day (i.e. analyzed by age rather than by dose), there are no examples included in any of the published SEND IGs.

SENDIG-DART v1.2 adds one new domain, that is the DP domain for development milestones. While the domain is new, there are no new variables added to the Implementation Guide (IG). The update shows how the existing concepts introduced in v1.1 can now be applied to juvenile studies.

As well as this addition, some existing sections were updated to add clarification, particularly in light of the results of the FDA’s Fit-For-Use (FFU) pilot. Feedback from the FFU pilot made it apparent that there was confusion around the representation of the study day, the dose day and the reproductive phase day. A new section has been added which describes how these are independent concepts and how each should be represented. I hope that this addition really clears things up for those implementing SENDIG-DART.

SENDIG-DART 1.2 is currently out for public review, so please take the time to review and comment on the document. Once complete with public review, and assuming that no significant issues are found, the document is due for publication in early 2023. For the public review, the document is accompanied by an updated version of the SEND Conformance Rules and a proof of concept study. The CDISC SEND DART team has put a huge amount of work and many volunteer hours into producing this update and its supporting materials. I’m very thankful to them for all the effort and expertise they offer.

‘til next time

Marc

Published by Marc Ellison

Self-confessed SEND nerd who loves geek-ing out about everything to do with SEND. Active CDISC volunteer and member of the CDISC SEND extended leadership team. Director of SEND solutions at Instem responsible for all our industry leading SEND products and services.