Sharing Data from Cardiovascular Clinical Trials — A Proposal

A new consortium, ACCESS CV, aims to provide avenues for data sharing while minimizing risks and unintended consequences. It has identified challenges including data complexity, publication and selection bias, increased risk of type I errors, and patient privacy. Participants in clinical research vo...

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Veröffentlicht in:The New England journal of medicine 2016-08, Vol.375 (5), p.407-409
Hauptverfasser: Patel, Manesh R, Armstrong, Paul W, Bhatt, Deepak L, Braunwald, Eugene, Camm, A John, Fox, Keith A A, Harrington, Robert A, Hiatt, William R, James, Stefan K, Kirtane, Ajay J, Leon, Martin B, Lincoff, A Michael, Mahaffey, Kenneth W, Mauri, Laura, Mehran, Roxana, Mehta, Shamir R, Montalescot, Gilles, Nicholls, Stephen J, Perkovic, Vlado, Peterson, Eric D, Pocock, Stuart J, Roe, Matthew T, Sabatine, Marc S, Sekeres, Mikkael, Solomon, Scott D, Steg, Gabriel, Stone, Gregg W, Van de Werf, Frans, Wallentin, Lars, White, Harvey D, Gibson, Michael
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Sprache:eng
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Zusammenfassung:A new consortium, ACCESS CV, aims to provide avenues for data sharing while minimizing risks and unintended consequences. It has identified challenges including data complexity, publication and selection bias, increased risk of type I errors, and patient privacy. Participants in clinical research volunteer in order to support the development of scientific knowledge and help future patients. Inherent in their commitment is the belief that research will lead to new insights that will be disseminated. As clinical researchers, we fully support the concept of data sharing as fundamental to achieving this goal. We formed the Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies — Cardiovascular (ACCESS CV) to provide avenues for sharing data from cardiovascular clinical trials while minimizing risks and unintended consequences. The goal of the consortium is to create a strategy to thoughtfully operationalize the . . .
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMp1605260