A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model
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A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model Cora Willoughby, MS Eli Lilly and Company, Indianapolis. Indiana
Doug Fridsma, MD, PhD University of Pittsburgh School of Medicine. Pittsburgh. Pennsylvania Lisa Chatterire, MS Digital Infuzion, Inc., Gaithersburg, Maryland John Speakaan National Cancer Institute, Rockville, Maryland
Julie Evans Clinical Data Interchange Standards Consortium. Austin, Texas Rebecca Kush, PhD Clinical Data Interchange Standards Consortium. Austin. Texas
Key Words Protocol; Clinical research; BRIDG: Standard; Model Corresponding Address Rebecca Kush. PhD. CDISC. 15907 Two Rivers Cove, Austin. TX 78717(e-mail: rkush @cdisc.org).
Today’s clinical trial processes are ineficiently mired in excessive documentation and unnecessary human intervention. The protocol lies at the heart of these opemtions, making it a prime candidatefor the benefits affordedby computer processing. With a vision to develop a standard machine-readableprotocd, the Protocol Representation (PR) group, a team within the Clinical Data Interchange Standards Consortium (CDlSC), identified a set of elements common to regulated clinical research protocds. These dements are being incorpomted into the Biomedical Research Integrated Domain Group (BRlDG) model, an information model of biomedical research initiated by CDISC and collaboratively developed and maintained by
INTRODUCTION Scientific communication in the biopharmaceutical industry occurs largely through documents, as evidenced by the elaborate document management processes and the volumes of paper that are features of traditional drug development and marketing. Although sophisticated techniques and tools are available for managing these documents, the number of documents that must be managed within any one organization continues to escalate. This increase in complexity limits our abilities to identify, to find, and to retrieve key items of information within and across these documents, as well as our ability to reuse the information effectively and efficiently. Mired in documentation, current clinical research processes are heavily dependent on human intervention, complex data integration steps, and interpretation. The translation and transcription of salient clinical information from these documents into other documents and databases, so that it can be used to drive related internal and external processes, including report generation and knowledge management, is essentially still a manual process. Perhaps the
CDISC, Health Level Seven (HL7), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and other stakeholders. l%ePR group plans to use BRIDG as a pathway to develop a standard structuredprotocol representation so that protocd information can be repurposed across multiple clinical research documents, databases, and systems from study start-up through reporting and regulatory submissions. The BRIDG mod4 provides a means of knowledge acquisition, a toof for communication, a f...sfor cdlaboration, a starting
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