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| | Becky Kush |
Since its inception in 1997, 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. Spearheading this effort is Becky Kush, Ph.D., president and CEO, who oversees a staff of 10 and provides vision to many dozens of dedicated volunteers from its 200 member organizations who have put a number of clinical research data standards into production and are working on additional initiatives with partners such as FDA and the National Cancer Institute (NCI). Becky Kush recently spoke with
eCliniqua about some of CDISC’s successes, latest projects and about her role in the organization. Because of the breadth of the ongoing work at CDISC, this will be a two-part series.
eCliniqua: As more regulatory bodies around the globe are starting to demand electronic submissions, what does that mean for CDISC?
Kush: We are at an exciting juncture. 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. Currently, there is a guidance on eSubmissions using the electronic common technical document (eCTD), which specifies use of the study data tabulation model (SDTM) and there is every reason to believe that the rule would require its use.
How is CDISC preparing for the increased demand for electronic submissions?
Kush: To get ready for this, FDA has asked us to train its reviewers on SDTM, and so far we have trained almost 200. Also, there has been a gradual increase in the request for education courses, both in a public forum and privately for some of our member companies. Most of our courses have been face-to-face training. Right now, we don’t have enough resources to accommodate what we anticipate coming next year, so we posted an RFP [request for proposals] and got a good response to get additional instructors. At the CDISC International Interchange in October, we rolled out a new virtual learning tool on the SDTM.
Can you explain the CDASH initiative and how CDISC got involved with it?
Kush: CDASH stands for Clinical Data Acquisition Standards Harmonization http://cdisc.org/standards/cdash/cdash.html, an opportunity that 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. CDASH focuses on defining standardized data collection fields in the CRF to collect safety data and medication information across applications and sponsors. The data fields are mapped to CDISC’s SDTM, and there will be an extensible markup language (XML) version based on the operational data model (ODM) transport standard used to collect data electronically.
In 2006, we took the lead for CDASH at the request of FDA and the Association of Clinical Research Organizations (ACRO) when that association realized that it needed more resources to complete the work and that a standards organization was best suited for this. There is now a collaborative group of fifteen organizations, including ACRO and several companies, academic institutions, government agencies, and other associations providing direction for CDASH.
Are CDISC standards catching on internationally?
Kush: Yes. We have incredibly active groups in Japan and Europe where we hold Interchanges every year. These groups are called CDISC Coordinating Committees in Europe and Japan, and they have ex-officio seats on our Board. They are very much a part of our organization, a very integral part. In Europe, we have user networks starting and they are language-based in Italian, French, German, English, and Scandinavian languages—Swedish and Danish—because people wanted to get together and discuss implementation issues. The U.S. has region-based user networks in the Delaware Valley, Atlantic region (New York, New Jersey, Pennsylvania), Chicago, Boston, Seattle, Washington, D.C., Research Triangle Park, the Bay Area, and the Midwest.
After 10 years with CDISC, how do you see your role in the organization?
Kush: I 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. I keep trying to focus on the vision and mission of CDISC. I also oversee our external relationships. We have just been voted into ISO [the International Organization for Standardization] with Liaison A status, a level that is enjoyed by only two or three organizations, and we also have a charter relationship with HL7 [an ANSI standards developing organization].
Read Part 2: Linking Clinical Data and Electronic Health Records.
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This article first appeared in Bio-IT World’s eCliniqua newsletter. Click here for a free subscription to eCliniqua.