This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko who leads the CDISC team developing the SEND standard for Genetic Toxicology. I asked him “What is the current scope and timeline of the SEND Genetox Implementation Guide?”, and here’s what he had to say:
“Some context is in order first. The CDISC SEND GeneTox team, founded in 2015, has been working in an evolving state, as there have been many changes to scope, leadership and even CDISC practices. The initial scope and intent was to model and create domains to support in vivo Micronucleus and Comet assays, as well as in vitro Micronucleus and in vitro Ames assays. In addition to the representation of the raw data and trial design for in vivo data, the team planned to find a way to represent historical control data. In vitro data and historical control data are two concepts which no CDISC team had ever ventured to undertake.
As the team worked through the scope initiatives, it became apparent that in vitro and historical control data had not been attempted for a good reason. It was extremely challenging to represent data without a subject attached to the data. After many trials and tribulations, it was decided to reduce the scope to the smallest effective scope, which would provide investigators and agencies a way to standardize the genetox data at least for in vivo. This could set a foundation for the future as well as lessons learned. This would be similar to the process of SENDIG v3.0 being released: industry implementing and then lessons learned driving future releases. Thus, the scope was reduced to in vivo Micronucleus and in vivo Comet assays. Then with agency feedback, it was determined historical data did not need to be included. The rationale was that either methodologies would be too complex to represent historical data, or it would severely increase the size/width of the GeneTox SEND domain representing the raw data. Neither was ideal; thus it was agreed to remove historical data.
Upon decision of the refined scope, work in the SEND GeneTox IG has been moving quickly. Granted new CDISC practices have been introduced along the way. Currently the draft IG is almost complete, including 3 detailed examples to represent the following:
- in vivo Micronucleus slide based assay,
- in vivo Micronucleus flow based assay and
- in vivo Comet assay.
The team has already worked with the Controlled Terminology team to develop controlled terminology and is working with the SEND Conformance Rules team. As part of newer CDISC processes, not only must an IG contain examples, but for CDISC Internal and Public Review, it must be accompanied by the Conformance Rules as well as Proof of Concept datasets. This will allow a more thorough review as well allow agencies and vendors to assess with their SEND tools. The current roadmap puts the SENDIG-GeneTox out for public review in early Q3 2022, with approval and publication hopefully by end of Q1 2023. It has been a road of challenges and changes, but the team came together and are getting it done.”
I thought that was a great update for Mike to share.
As usual, feel free to join the conversation and drop me a note at marc.ellison@instem.com
Till next time,
Marc
Sensible SEND Blog 