American industry and the U.S. Cardiovascular Clinical Research Enterprise an appropriate analogy?

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Translational Medicine Institute, Durham, North Carolina.
Journal of the American College of Cardiology (Impact Factor: 15.34). 08/2011; 58(7):677-80. DOI: 10.1016/j.jacc.2011.03.048
Source: PubMed
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    ABSTRACT: Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care.
    Journal of the American College of Cardiology 05/2013; 61(18):1835–1846. · 15.34 Impact Factor
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    ABSTRACT: The purpose of this study was to quantitatively examine the association of patient- and trial-specific factors with participation in cardiovascular randomized clinical trials. Randomized clinical trials are central to evidenced-based medicine, but low patient participation rates and potentially modifiable barriers are not well understood. At a large U.S. academic health system, we examined screening logs from December 1, 2005, to February 28, 2011, from 15 cardiovascular randomized clinical trials. We identified 655 patients who were screened and potentially eligible for participation in at least 1 trial. We used multivariable Poisson regression to quantify the risk of not participating in a trial associated with patient- and trial-specific factors. The median age was 63 years (interquartile range: 54 to 72), 35% were women, and the median Charlson Index was 2 (interquartile range: 1 to 5). Forty-two percent of patients did not participate in a trial. In multivariable regression (C-Index 0.85), trial-specific factors strongly associated with not participating included intensive trial-related testing (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.63 to 2.20) and anticipated trial participation >6 months (RR: 4.10; 95% CI: 2.30 to 7.29). Patient-specific factors associated with not participating included older age (RR: 1.23; 95% CI: 1.11 to 1.36, per 10-year increase if age ≥65 years), out-of-state residence (RR: 1.26; 95% CI: 1.04 to 1.54), and female sex (RR: 1.17; 95% CI: 1.01 to 1.35). Race was not associated with participation. While patient-specific factors were associated with not participating in cardiovascular trials, longer trial duration and intensive trial-related testing were most strongly associated with risk for patients not participating. Innovative trial designs fostering convenience may most enhance trial participation.
    Journal of the American College of Cardiology 02/2013; 61(7):762-9. · 15.34 Impact Factor
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    ABSTRACT: Numerous challenges-financial, regulatory, and cultural-are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as well as the broader clinical trial enterprise. To promote consensus around the solutions needed to address the adverse trends in clinical research, the Duke Clinical Research Institute convenedstakeholders from academia, industry, and government. article summarizes the proceedings of this meeting and addresses: (1) adverse trends in the United States and multinational clinical trials, (2) the key issues that underlie these adverse trends, and (3) potential solutions to these problems.
    American heart journal 06/2013; 165(6):837-847. · 4.56 Impact Factor


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