Data Sharing Statements for Clinical Trials — A Requirement of the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an e...

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Veröffentlicht in:The New England journal of medicine 2017-06, Vol.376 (23), p.2277-2279
Hauptverfasser: Taichman, Darren B, Sahni, Peush, Pinborg, Anja, Peiperl, Larry, Laine, Christine, James, Astrid, Hong, Sung-Tae, Haileamlak, Abraham, Gollogly, Laragh, Godlee, Fiona, Frizelle, Frank A, Florenzano, Fernando, Drazen, Jeffrey M, Bauchner, Howard, Baethge, Christopher, Backus, Joyce
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Sprache:eng
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Zusammenfassung:The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups. 1 Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the . . .
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMe1705439