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Standards Questions

By Ann Neuer
CDISC's Becky Kush looks forward to new FDA rules.

Dec. 17, 2007 | Celebrating its 10th anniversary this year, CDISC - the Clinical Data Interchange Standards Consortium - has become a major voice in the pharmaceutical industry for its work in developing platform-independent data standards for the electronic acquisition and exchange of clinical trial data and metadata. The group was recently voted into the International Organization for Standardization (ISO) with Liaison A status - a level enjoyed by only a few organizations, and maintains a charter relationship with HL7 (Health Level Seven), the health care standards body.

Spearheading CDISC is president and CEO Rebecca (Becky) Kush who, with her staff of ten, provides vision to dozens of dedicated volunteers from its roughly 200 member organizations. Those organizations have implemented many clinical research standards and are working on additional initiatives with partners such as FDA and the National Cancer Institute (NCI).

"We are at an exciting juncture," Kush told Bio-IT World. "FDA is writing a proposed rule to require electronic submissions of clinical data in New Drug Applications (NDAs), Biological License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs) in a format that FDA can process, review, and archive."  The FDA has issued a guidance on eSubmissions using the electronic common technical document (eCTD), which specifies use of the Study Data Tabulation Model (SDTM). Kush says, "There is every reason to believe that the rule would require its use."

Training the Corps
FDA has asked CDISC to train its reviewers on SDTM. Kush says her team has trained almost 200 people so far. There is also growing demand for education courses, both in public forums and privately for constituents. CDISC is recruiting additional instructors to keep up with demand. Most of the courses have been face-to-face training, but at the CDISC International Interchange in October, CDISC launched a new virtual learning tool on SDTM.

An exciting initiative is CDASH (Clinical Data Acquisition Standards Harmonization). Says Kush: "This opportunity grew out of the FDA Critical Path initiative to develop standards to support data collection in the case report form (CRF) at the level of the investigative site." In 2006, FDA and the Association of Clinical Research Organizations (ACRO) requested CDISC take the lead. "CDASH focuses on defining standardized data collection fields in the CRF to collect safety data and medication information across applications and sponsors," Kush says. "The data fields are mapped to CDISC's SDTM, and there will be an XML version based on the Operational Data Model (ODM) transport standard used to collect data electronically."

Another initiative called BRIDG - the Biomedical Research Integrated Domain Group model - is an effort to link CDISC clinical standards to healthcare standards developed by HL7. "This effort is intended to reach consensus around the meanings of the elements used in clinical research," says Kush. "For example, in terms of semantics, how is 'enrollment' defined? How is 'adverse event' defined?" Last June, CDISC and partners released BRIDG model version 1.1 - the fruits of a three-year collaboration with FDA, NCI, and HL7. The National Cancer Institute's caBIG (cancer Biomedical Informatics Grid) initiative is also part of the BRIDG effort, seeking to achieve interoperability among clinical trials research in cancer.

Catching On
There is growing acceptance of CDISC standards internationally. "We have incredibly active groups in Japan and Europe, where we hold interchanges every year," Kush says. These European and Asian coordinating committees are "a very integral part" of CDISC, she says. Several user networks have sprung up in Europe in various languages, "because people wanted to get together and discuss implementation issues."

Ten years post launch, Kush says her main focus is to "hold everything together, ride the political waves. Seriously, my role is to continue to paint the CDISC vision to make sure we see that shining star and see where we are headed. The technical people need to look at the details but unless they can also see the grand picture, they may get lost as to why they are doing what they are doing." 

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