The need for a more efficient and effective infrastructure for clinical research has been articulated by ARRA, as well as by the NIH clinical roadmap initiative. One of the greatest national inefficiencies of the current model of clinical research is the lack of a sustaining infrastructure (including shared resources, common data standards, and effective use of information technology) among researchers. Clinical investigator networks are the master key toward unlocking the nation's clinical research capacity. We propose a partnership between the Duke Clinical Research Institute (DCRI) and the American College of Cardiology (ACC) to develop a clinical investigator network based upon the data collection activities of the National Cardiovascular Data Registries (NCDR.) These registries have previously been used to quantify outcomes and identify gaps in the delivery of quality cardiovascular patient care in the United States. We seek to extend and unify these sites with a centralized clinical research network that will facilitates interoperable clinical research by enhancing site recruitment, training, performance, and accountability and by creating a sustained improvement in the efficiency and quality of the interaction between the clinical research subject, the clinician investigator, the expert guidelines committee, and policymakers. This approach has four components: First, we will implement programs and tools focused on building site capability with the ultimate goal of enhancing the recruitment, retention, and performance of clinical research sites. Second, we will facilitate standards and interoperability for cardiovascular clinical research through a partnership with the clinical data interchange standards consortium (CDISC) and the NCDR. Third, we will create and implement a proposal development system to solicit and bring the best ideas for research questions from initial concept to execution in the most efficient fashion, including preparation suitable for government, foundation, or industry funding, with a focus on encouraging public/private partnerships. Finally, we will develop a network informatics infrastructure that can be applied and used across multiple networks and provide an integrated electronic repository of tools and programs to assist the site in its study conduct activities while fostering communication across sites and networks.
The Duke Clinical Research Institute (DCRI) and the American College of Cardiology (ACC) propose a clinical investigator network based upon the data collection and informatics activities of the National Cardiovascular Data Registries (ACC-NCDR.) We will add randomization capabilities to the NCDR, thereby establishing a National Cardiovascular Research Infrastructure (NCRI). The NCRI will unify sites with a centralized clinical research network that will enhance site recruitment, training, performance, and accountability, and improve interactions between the clinical research subject, the clinician investigator, the expert guidelines committee, and policymakers.
| Anderson, H Vernon; Weintraub, William S; Radford, Martha J et al. (2013) Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project. J Am Coll Cardiol 61:1835-46 |
