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An academic ECG core lab perspective of the FDA initiative for digital ECG capture and data management in large-scale clinical trials

Johanson, P; Armstrong, P W; Barbagelata, N A; Chaitman, B R; Clemmensen, P; Dellborg, M; French, J; Goodman, S G; Green, C L and Krucoff, M W, et al. (2005) In Drug Information Journal 39(4). p.345-351
Abstract
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... (More)
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. (Less)
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publication status
published
subject
keywords
acute coronary syndromes, ECG, clinical trials, prognosis
in
Drug Information Journal
volume
39
issue
4
pages
345 - 351
publisher
Pergamon
external identifiers
  • wos:000233187900002
  • scopus:27744461668
ISSN
0092-8615
language
English
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yes
id
2bd8f0a9-1736-40fb-8a7e-b4d962b77fd2 (old id 213932)
date added to LUP
2007-08-03 11:08:20
date last changed
2017-01-01 05:15:32
@article{2bd8f0a9-1736-40fb-8a7e-b4d962b77fd2,
  abstract     = {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.},
  author       = {Johanson, P and Armstrong, P W and Barbagelata, N A and Chaitman, B R and Clemmensen, P and Dellborg, M and French, J and Goodman, S G and Green, C L and Krucoff, M W and Langer, A and Pahlm, Olle and Reilly, P and Wagner, G S},
  issn         = {0092-8615},
  keyword      = {acute coronary syndromes,ECG,clinical trials,prognosis},
  language     = {eng},
  number       = {4},
  pages        = {345--351},
  publisher    = {Pergamon},
  series       = {Drug Information Journal},
  title        = {An academic ECG core lab perspective of the FDA initiative for digital ECG capture and data management in large-scale clinical trials},
  volume       = {39},
  year         = {2005},
}