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An academic ECG cor...
An academic ECG core lab perspective of the FDA initiative for digital ECG capture and data management in large-scale clinical trials
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- Johanson, Per, 1963 (author)
- Gothenburg University,Göteborgs universitet,Hjärt-kärlinstitutionen,Cardiovascular Institute
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Armstrong, P W (author)
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Barbagelata, N A (author)
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Chaitman, B R (author)
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Clemmensen, P (author)
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- Dellborg, Mikael, 1954 (author)
- Gothenburg University,Göteborgs universitet,Hjärt-kärlinstitutionen,Cardiovascular Institute
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French, J (author)
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Goodman, S G (author)
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Green, C L (author)
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Krucoff, M W (author)
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Langer, A (author)
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- Pahlm, Olle (author)
- Lund University,Lunds universitet,Klinisk fysiologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Clinical Physiology (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine
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Reilly, P (author)
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Wagner, G S (author)
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Krucoff, MV (author)
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(creator_code:org_t)
- 2005
- 2005
- English.
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In: Drug Information Journal. - 0092-8615. ; 39:4, s. 345-351
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Abstract
Subject headings
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- Maximal utility of accessible data is attractive to all partners in clinical research, whether it directly improves patient care or more accurately allows identification of the safety and efficacy of a new drug or procedure. The Food and Drug Administration (FDA) has presented a guideline draft addressing digitization of electrocardiogram (ECG) data in clinical trials to improve the standards for collection, analysis, and storage of safety information on new medical therapies. This FDA initiative has led to discussions and collaboration among the FDA, the pharmaceutical industry, the electrocardiographj, manufacturers, and the academic as well as the nonacademic EGG core labs. In this article, we present a broad-based viewpoint from two groups of academic EGG core labs, the Alliance of Academic EGG Core Labs and the Virtual Electronic EGG Corelab International Consortium. We have chosen to widen the perspective from using digitized EGG data in safety trials only, as addressed by the FDA guideline draft, to a discussion on the possibilities and the potential problems when using digitized EGG data also in large clinical trials focusing on efficacy measurements. We conclude that the benefit of digital data mining is probably well worth an initial incremental effort and expense.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
Keyword
- acute coronary syndromes
- ECG
- clinical trials
- prognosis
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Johanson, Per, 1 ...
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Armstrong, P W
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Barbagelata, N A
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Chaitman, B R
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Clemmensen, P
-
Dellborg, Mikael ...
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show more...
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French, J
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Goodman, S G
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Green, C L
-
Krucoff, M W
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Langer, A
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Pahlm, Olle
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Reilly, P
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Wagner, G S
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Krucoff, MV
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Respiratory Medi ...
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Drug Information ...
- By the university
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Lund University
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University of Gothenburg