A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model

Abstract

Today’s clinical trial processes are inefficiently mired in excessive documentation and unnecessary human intervention. The protocol lies at the heart of these operations, making it a prime candidate for the benefits afforded by computer processing. With a vision to develop a standard machine-readable protocol, the Protocol Representation (PR) group, a team within the Clinical Data Interchange Standards Consortium (CDISC), identified a set of elements common to regulated clinical research protocols. These elements are being incorporated into the Biomedical Research Integrated Domain Group (BRIDG) model, an information model of biomedical research initiated by CDISC and collaboratively developed and maintained by CDISC, Health Level Seven (HL7), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and other stakeholders. The PR group plans to use BRIDG as a pathway to develop a standard structured protocol representation so that protocol information can be repurposed across multiple clinical research documents, databases, and systems from study start-up through reporting and regulatory submissions. The BRIDG model provides a means of knowledge acquisition, a tool for communication, a focus for collaboration, a starting point for application development, a means to standards development and harmonization, and an informatics research platform to support clinical research.