The Nov. 28, 2007, issue of
eCliniqua ran
Part 1 of this interview with CDISC President and CEO Becky Kush, which focused on the growing use of
CDISC (Clinical Data Interchange Standards Consortium) standards. Part 2 focuses on the BRIDG initiative and CDISC’s role in today’s cutting-edge efforts to link clinical data with electronic health records (EHRs).
eCliniqua: What is the BRIDG model?
Kush: BRIDG refers to the Biomedical Research Integrated Domain Group model, which is a domain analysis model meant to link CDISC standards for clinical research to those from Health Level Seven (HL7), an organization that develops standards for healthcare. BRIDG helps machines understand each other and the meaning of what they are trying to exchange. Our first effort is to reach consensus around the meanings of the elements used in clinical research. For example, in terms of semantics, how is “enrollment” defined? How is “adverse event” defined?
I understand that BRIDG model version 1.0 was released in June. Why is this important?
Kush: The release of BRIDG model version 1.0 is significant because it represents a useful outcome from a three-year collaboration among CDISC, FDA, National Cancer Institute (NCI), and HL7, the four organizations that govern BRIDG. CDISC started developing this model in early 2004. Later that year, NCI’s caBIG (cancer Biomedical Informatics Grid) initiative joined the BRIDG effort to achieve interoperability among clinical trials research in cancer. BRIDG also been adopted by the HL7 Regulated Clinical Research Information Management (RCRIM) Technical Committee as its domain analysis model. RCRIM develops standards to improve information management during research, and BRIDG is the conceptual backbone to which all RCRIM and CDISC implementation models link. This creates interoperability across the medical research and healthcare worlds. Version 1.1 was released in November, and with that release, CDISC’s Study Data Tabulation Model (SDTM) and the Trial Design Model are now in BRIDG.
How is CDISC involved in the trend toward integrating clinical data with electronic health records?
Kush: The best way to answer that question is to explain various attempts to integrate the two through the CDISC Healthcare Link initiative led by Landen Bain. Last year at the Healthcare Information and Management Systems Society (HIMSS) annual meeting, CDISC did a big demo of the integration profile we developed for using EHRs for different purposes, such as clinical studies, biosurveillance, and safety reporting. We used the Retrieve Form for Data Capture (RFD) integration profile developed through Integrating the Healthcare Enterprise and CDISC’s Operational Data Model standard to show how an electronic health record can pull in a form that a doctor is using, such as a case report form (CRF), a biosurveillance form, or a drug safety reporting form, which can then be completed by the doctor within that system. The forms are populated with data that can go into the EHR, to the sponsor of clinical research, or to other stakeholders such as FDA.
How else is CDISC involved in the clinical research/EHR integration effort?
Kush: There are three upcoming implementations that are being conducted within the CDISC Healthcare Link initiative. Pfizer is spearheading a collaborative effort with Partners HealthCare in Boston and CRIX International on the use of the EHR for streamlining drug safety reporting. They are pre-populating the safety report form as much as they can, using information from the EHR. This implementation should launch by the end of 2007 or early in 2008. Eli Lilly is working with Cerner and Quintiles on clinical trials workflow whereby they are going to pull in a CRF and model it after our CDASH (Clinical Data Acquisition Standards Harmonization) initiative. This effort is still in development. A third implementation is being conducted by NIH and involves safety reporting to meet NIH, institutional review board (IRB), and FDA requirements as defined by a Federal Adverse Event Task Force. Sites are currently being evaluating for this project. In all three cases, standards for the adverse event data and other standards are being harmonized in BRIDG.
Are there any final comments you wish to make?
Kush: A lot of efforts aimed at linking EHRs with clinical research are coming together. For example, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the eClinical Forum are working on an EHR profile that describes what EHRs need in order to leverage them for clinical research. This effort is referencing several of the CDISC standards and initiatives.
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This article first appeared in Bio-IT World’s eCliniqua newsletter. Click here for a free subscription to eCliniqua.