In the prior CDISC Blog, Dave Iberson-Hurst explored the ‘disappearing’ timelines for the HL7 transport mechanisms for CDISC content. Since these HL7 standards (which by the way will be co-owned by CDISC and HL7 if and when they are ready) are not yet available nor tested, what does FDA want to see now (TODAY) when it comes to data standards?
I will share in this blog certain messages that came through strongly from FDA representatives on the afternoon of 12 November at the CDISC Interchange.
First, Dr. Sharfstein’s keynote presentation contained powerful and transformative phrases such as:
It behooves us all to move to standards as an industry.
FDA values standards.
Reliable data standards are critical for effective health policy; they are the building blocks for reusing data and, without data standards, systems are islands.
FDA is really committed to CDISC.
And, there is a connection between Ethics and Data Standards--- a high quality analysis needs high quality data submitted.
From the FDA Panel, here are messages about what to do NOW:
- Use CDASH at the beginning of new studies.
- This will eliminate much of the ‘back-end’ mapping that is occurring now to try to put data collected in various ways into the SDTM format. CDASH is based upon SDTM; if one is going to submit data in SDTM format, collecting it in CDASH makes sense!
- Using CDASH ‘up front’ in studies has also been shown to significantly reduce time and cost for study start-up. (See the Gartner Business case or read the CDISC book.)
- Use define.xml now for eSubmissions to CDER and CBER.
- The HL7 transport format is not available yet, hence the request to use define.xml for the transport of data in the CDISC standard format (SDTM) for eSubmissions.
- Use SDTM and adhere as closely as possible to the standard.
- eSubmissions coming into FDA in a standard format are going to get “a different review” from those that are in non-standard format. With standard data, issues can be addressed earlier in the process. Reviewers are being trained in SDTM and ADaM. Reviewers receiving data in a standard format are going to be more comfortable with the review and may tend to be more positive as a result.
The FDA is engaged in creating a modern review environment and process. They are committed to setting up a means to determine the adherence to the SDTM standard in submissions they receive and to providing feedback--- to CDISC on the standard, and to those providing eSubmissions on their adherence. This feedback is intended to be helpful to all of us such that SDTM can be refined, additional data elements (e.g. for the efficacy data) can be developed and the FDA can be more transparent and share their methods openly.
Also occurring the week of the Interchange and of relevance to this topic:
- FDA representatives spent the better part of 9 November with CDISC Operations discussing their desire to see more efficacy standards to augment the CDISC safety standards and how CDISC can help in this regard.
- FDA representatives were at the CDISC Board meeting on 10 November to discuss how to best work with CDISC and its stakeholders. They offered to share their 12-18 month plan with the CDISC Executive Committee to help ensure that the CDISC goals are aligned with theirs.
- Dr. Sharfstein committed to raising the concern voiced during the Q&A session about the need for a plan indicating what the FDA wants to see now, what they want in the future and how they are going to get from here to there…along with the CDISC community. He followed up on this the very next day and we are anticipating additional information from FDA in this respect.
Rebecca Kush, CDISC CEO & President