Abstract
EMWA team responds to ICMJE requirements on sharing clinical trial data
In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of Internal Medicine.1 The ICMJE stated its belief “…that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world – foundations, government agencies, and industry – now mandate data sharing”. The editorial outlined ICMJE’s proposed requirements to help meet this obligation, and encouraged feedback on the proposed requirements at www.icmje.org by 18 April 2016.
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References
- Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing clinical trial data: A proposal from the International Committee of Medical Journal Editors. Ann Intern Med. 2016;164(7): 505-506.
- Retraction Watch. Sharing data is a good thing. But we need to consider the costs. [cited April 2016]. Available from: http://retractionwatch.com/2016/01/28/ sharing-data-is-a-good-thing-but-we-needto- consider-the-costs/
- LinkedIn. European Medical Writers Association. Available from: https://www.linkedin.com/grp/post/ 2717752-6102832116159049732
- LinkedIn. The Publication Plan. Available from: https://www.linkedin.com/groups/ 1886265/1886265-6130063859827957764
- TransCelerate BioPharma Inc. Common Protocol Template [cited 2016 Apr 1]. Available from: http://www.transceleratebiopharmainc.com /initiatives/common-protocol-template/
- U.S. Food and Drug Administration. FDA and NIH release a draft clinical trial protocol template for public comment [cited 2016 Apr 1]. Available from: http://blogs.fda.gov/fdavoice/?s=protocol
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- Phillip Leventhal (Evidera, Lyon, France)
Co-Editor:
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
- Clare (Chi-Chih) Chang
- Jonathan Pitt
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting Ltd., Cambridge, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Claire Gudex (University of Southern Denmark, Odense, Denmark)
- Sam Hamilton (Newcastle Upon Tyne, UK)
- Anu Alahari
- Evguenia Alechine
- Kelly Goodwin Burri (Stryker GmbH, Selzach, Switzerland)
- Stephen Gilliver
- Amy Whereat
- Jennifer Clemens
- Karim Montasser
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)