Interactions between the health care and clini- cal research communities are currently ineffi- cient. The present environment forces unneces- sary redundancy, from the capture of patient data in the clinician-patient encounter to multi- ple uses of that data. Clinical research opera- tions must become more integrated with health care processes to improve efficiencies in both patient care and research. Achieving a single in- stance of data capture to serve the combined needs of both environments should facilitate translation of knowledge from research into bet- ter patient care. A critical first step in achieving true interoperability is to develop formal data standards that are then adopted by the larger health care and research communities. The re- wards of interoperability include streamlined subject screening and enrollment procedures, improved reporting, merging and subsequent analysis of clinical data sets, and expansion of knowledge made possible by leveraging research data and results from other domains in the health care community—all of which would in- crease the quality of patient care. The aggrega- tion of data across multiple sites and the subse- quent reuse of that data do face challenges, particularly in ensuring patient privacy; how- ever, these can be overcome by technological in- novation and consensus-building among stake- holders. 393 INTRODUCTION The need for a more efficient and effective ap- proach to clinical research has been articulated by numerous public (1,2) and private (3,4) or- ganizations over the past several years. Enor- mous amounts of private and public funds are devoted to the organization of clinical trial groups to test individual drugs, devices, and treatment practices. However, once the research is completed, the groups are disbanded, only to be reconstituted at great expense when the next new project appears on the scene. The creation of a system that translates knowledge acquired during research into clinical practice is thus an important goal for the clinical research system. One of the greatest inefficiencies of the current model of clinical research in the United States is its lack of a sustaining infrastructure that in- cludes streamlined, one-time entry data collec- tion, common data standards and terminology, and cooperative use of data shared among re- searchers (5). More importantly, the findings of appropri- ately conducted clinical research must be inte- grated into patient care with more efficiency and effectiveness. As stated by M. L. Milleson in 1997, “There is an unsettling, if little known, truth about the practice of medicine. . . . Study after study shows that few physicians systemati- cally apply to everyday treatment the scientific evidence about what works best” (6). Clinical re- search provides the “evidence” in evidence- based medicine; however, clinical trials are only part of the cycle of therapeutic improvement (Figure 1). This cycle highlights opportunities to integrate quantitative strategies to improve the quality of patient care and has been adapted to focus on the underlying flow and interde- pendency of data (7). The conduct of research and the application of the knowledge gained must be aligned with the diagnostic process, treatment guidelines, and decision support tools, not only to improve patient care but also to lessen the burden that research places on sites. Patient care facilities conducting clinical re- search are central to the interaction between health care and research. Critical to the devel- opment of research tools, workflow, and knowl- Drug Information Journal, Vol. 41, pp. 393–404, 2007 • 0092-8615/2007 Printed in the USA. All rights reserved. Copyright © 2007 Drug Information Association, Inc. Data Standards: At the Intersection of Sites, Clinical Research Networks, and Standards Development Initiatives Brian McCourt, BA, CCDM Duke Clinical Research Institute, Durham, North Carolina Robert A. Harrington, MD Duke Clinical Research Institute, Durham, North Carolina Kathleen Fox, RN, BS Duke Clinical Research Institute, Durham, North Carolina Carol Dukes Hamilton, MD Duke Clinical Research Institute, Durham, North Carolina Kimberly Booher Duke Clinical Research Institute, Durham, North Carolina William E. Hammond, PhD Duke School of Medicine, Durham, North Carolina Anita Walden Duke Clinical Research Institute, Durham, North Carolina Meredith Nahm, MS Duke Clinical Research Institute, Durham, North Carolina This project has been funded in whole or in part with federal funds from the National Institutes of Health, under contract numbers HHSN268200425212C and HHSN268200425214C, “Re-engineering the Clinical Research Enterprise.” Key Words Functional interoperability; Semantic interoperability; Clinical data standards; Data reporting; Terminology; Data elements Correspondence Address Brian McCourt, Duke Clinical Research Institute, 2400 Pratt Street, Room 0311 Terrace Level, Durham, NC 27705 (e-mail: brian.mccourt@duke.edu). CLINICAL RESEARCH STANDARDS