Applied Clinical Trials
For those working with clinical data standards, figuring out when to use HL7 standards versus CDISC standards can prove challenging to say the least.
Historically, CDISC was the first organization to promote the use of data standards within clinical research. CDISC has developed a suite of standards such as SDTM, SEND, ODM, ADaM, Define.xml, LAB, CDASH and others. Over time, HL7, which develops standards for broader health care uses, has been more directly involved in standards for clinical research such as SPL, RPS, and ICSR. This apparent overlap has created confusion.
To help industry professionals differentiate between standards, Wayne R. Kubick, MBA, Senior Vice President of Phase Forward Lincoln Safety Group, will be presenting a session entitled “Standards Shock Therapy: Monitoring the State of CDISC and HL7 Standards for Clinical Research and Regulatory Submissions,” on June 15 from 2 p.m. to 3:30 p.m. at the 46th Annual DIA meeting.
“The purpose of this session is to try to clarify for people who are involved with data standards and the industry the difference between CDISC and HL7 standards, what they should be doing today, and what they should be doing in the future,” Kubick said. “This is actually the third time I’ll be holding this session. We’ve basically (in the past) presented here is where we are with CDISC, here is where we are with HL7, and here is what we need to be doing now.”
Different organizations and individuals have varying views on the state of CDISC and HL7.
For instance, FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have recently stated they believe the CDISC standards are best suited to their current needs. Meanwhile, members of the FDA’s Office of the Commissioner have also noted the strategic importance of moving to HL7 standards in the near future.
To represent the broad spectrum of opinions regarding this topic, the DIA hosts a panel discussion with professionals from various backgrounds.
Every year the panel includes a CDISC, HL7, and FDA representative. This year, David P. Iberson-Hurst, Vice President, Technical Strategy, CDISC, UK, will represent CDISC, Jason Rock, Chief Technology Officer, GlobalSubmit Inc. will speak for HL7, and Jonathan Levine, Senior Scientific Policy Analyst, FDA Office of the Commissioner will give the FDA’s point of view. For his part, Kubick believes that CDISC standards are the best choice to use currently, but that in the future people may gravitate more towards using HL7, which is committed toward developing a broader framework for full semantic interoperability among all health care related participants.
“My opinion is the CDISC standards are very well oriented for the way we represent clinical trials data today based on the data we have in our possession and we have been collecting over time. HL7 is a very promising way to go in the future once we make the full transition to an electronic health records environment,” Kubick said.
Kubick explained that one of the main differences between HL7 and CDISC is that while CDISC was designed to support the current industry processes for managing and analyzing clinical data, HL7 was more focused on basic data interoperability among all health care participants.
“HL7 is much nearer to the world of health care than clinical research so it requires a significant reorganizing and restructuring of data from what sponsors currently know,” Kubick said. “From my perspective (HL7) requires a great deal of change in our process and understanding of how we use data right now which I find will be difficult to adopt initially. But I think as the world gets more and more electronic and we move more and more towards electronic health care records then HL7 will become increasingly important and probably CDISC will turn more toward content, analysis and reporting than developing data transport standards.”
This eClinical session will also look at a case study, the CDISC Content to Message project, which is examining an HL7 message structure for representing SDTM, SEND, and Define.xml content for regulatory submissions.
Though the session will have some of the same elements of past years, there will be plenty of new information for those who have attended in the past to soak up.
“This is a field of continuous change and significant evolutionary development. A lot of things have changed over the last year. It’s definitely a constantly changing thing so we are doing the best we can to help people navigate through that confusion,” Kubick said.