The CDISC SDTM model is considered the most stable of the CDISC standards: version 3.1.1 of the Implementation Guide (IG) was published in August 2005; 3.1.2 in November 2008 which has remained the accepted standard. However, in this year’s European Interchange, CDISC revealed an aggressive timeline of therapeutic area (TA) SDTM domain development. From slides 17 and 18 of the presentation you can see that 14 new TA domains are intended to be developed in 2012 alone. The overall goal is to standardise efficacy data elements from 57 TAs in 7 years.
The standard CDISC review process is to post an internal review of a standard, respond to the comments and update the standard, post for public review, respond to the comments, update the standard and then release it as a final version. All of this takes time, so will the development of these new SDTM domains be any different?
The speed of release will obviously reflect the complexity of the Therapeutic Areas. The Alzheimer’s standard consists of specific guidance to the MH, Non-Subject Medical History (NSMH – under development by SDTM team, which may well change as part of the Associated Person (AP) domain), biomarker guidance for LB, SC and the ADAS-cog questionnaire standard. So no custom domain development as such, more specific use of domains that are already available. Similarly the Pain TA standard makes extensive use of the QS domain (there are some 19 data collection instruments that have been mapped to QS), and includes detailed guidance for existing domains, but no new domains have been developed in support of this TA.
In contrast, the TB standard includes 4 new draft domains: Microscopic Findings (MI), Device in Use (DU), Morphology (MO) and Skin Response (SR), as well as guidance covering a raft of other SDTM domains, which obviously takes more time to prepare. (View the CDISC news with more details of released and pending TA domains.) However, we are nearing the end of 2012 and only 4 out of the 14 TAs due for release in 2012 have been released for review. Has CDISC and CFAST (Coalition For Accelerating Standards and Therapies) been too ambitious? Or will we see a raft of standards released in the last quarter of 2012? According to a recent CDISC news post, it could be a bit of both: there are currently 5 standards in development, which is still short of the target set for 2012.
With this proliferation of TA standards, will this mean we have to learn lots of new SDTM domains? Well, yes and no, depending on the TA. As stated above, the Alzheimer’s, Pain and TB standards build on the domains already available in the SDTM IG 3.1.2, with some new domains developed for TB. What it does mean is that there is a whole lot more documentation to review in order to ensure you are up to date with the SDTM standard. This requires time and resource ‘away from the day job’ which companies must devote to the review and dissemination of these new standards. Then there is the question of how the new TA standards are incorporated in any company CDISC standards. Do you do this gradually with any TA standards that are pertinent to your research? Do you update only when a new SDTM Implementation Guide is published with the new TAs incorporated? A lot to think about, and a lot to review if the CDISC – CFAST TA standards development proceeds as planned.